Davinci- what a scam

Electrocautery-associated vascular injury during robotic-assisted surgery.
Cormier B1, Nezhat F, Sternchos J, Sonoda Y, Leitao MM Jr.
Author information
Abstract
BACKGROUND:
The robotic surgical platform is increasingly used in gynecology and, similar to laparoscopy, it has risks of electrocautery-associated injury.
CASE:
We present three cases of injury caused by failures of the monopolar scissors' insulating sheath while coagulation and cutting currents were set at 35 W. In case 1, an external iliac vein injury required blood transfusion and emergent laparotomy. In case 2, a full-thickness external iliac artery injury was repaired robotically. In case 3, a partial-thickness external iliac artery injury also was repaired robotically.
CONCLUSION:
Unintended electrosurgical arcs can occur from monopolar instruments. Insulation failure is a common finding in this type of injury. Surgeons should avoid excessive instrument collisions and should change the monopolar scissors' insulating sheath if there are any concerns of a defect in its integrity.
PMID:22825276 [PubMed - indexed for MEDLINE]

6.

Stray Electrical Currents in Laparoscopic Instruments Used in da Vinci® Robot-Assisted Surgery: An In Vitro Study
To cite this article:
Carlos E. Mendez-Probst, George Vilos, Andrew Fuller, Alfonso Fernandez, Paul Borg, David Galloway, and Stephen E. Pautler. Journal of Endourology. September 2011, 25(9): 1513-1517. doi:10.1089/end.2010.0706.
Published in Volume: 25 Issue 9: September 8, 2011
Online Ahead of Print: August 4, 2011
ABSTRACT
Background and Purpose: The da Vinci® surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure. We used objective measures to report the prevalence and magnitude of such stray currents.
Materials and Methods: Thirty-seven robotic instruments were tested using an electrosurgical unit (ESU) at pure coagulation and cut waveforms at four different settings. Conductive gel-coated instruments were tested at 40W, 80W, and maximum ESU output (coagulation 120W, cut 300W). The magnitude of stray currents was measured by an electrosurgical analyzer.
Results: At coagulation waveform in open air, 86% of instruments leaked a mean of 0.4W. In the presence of gel-coated instruments, stray currents were detected in all instruments with means (and standard deviation) of 3.4W (±2), 4.1W (±2.3), and 4.1W (±2.3) at 40W, 80W, and 120W, respectively. At cut waveform in open air, none of the instruments leaked current, while gel-coated instruments leaked a mean of 2.2W (±1.3), 2.2W (±1.9) and 3.2W (±1.9) at 40W, 80W, and 300W, respectively.
Conclusions: All tested instruments in our study demonstrated energy leakage. Stray currents were higher during coagulation (high voltage) waveforms, and the magnitude was not always proportionate to the ESU settings. Stray currents have the potential to cause electrical burns. We support the programmed end of life of the da Vinci.
26-Mar-14
83348-L2-0001
26-Mar-14
Sacred Heart Health System
5151 North 9th Avenue
Pensacola, FL 32504-8795
ATTENTION Robotics Coordinatoratty Wilson
26-Mar-14
26-Mar-14


more boomsouce fucking pinto

 

More boomsauce for the investors and future victims (Plaintiffs).

The da Vinci line of robotic surgical systems for minimally invasive surgeries features monopolar scissors used to cut normally and to cauterize tissue through the application of monopolar electricity via an electrode, according to court papers. The defective devices were prone to tiny cracks, allowing electricity to enter into the patient's body and thus damaging tissue and internal organs, court filings said.

The plaintiff alleged that Intuitive found out about the defect through medical device reports that it had received from hospitals treating injured patients. The company allegedly responded by issuing secret recalls, unbeknownst to the U.S. Food and Drug Administration, and misclassified or failed to file the MDRs.

After the FDA allegedly met with Intuitive to discuss the misclassified or unfiled MDRs, the company reported a 40 percent higher number of MDRs, resulting in an FDA safety probe in January 2013 that caused company stock to drop 11 percent on Feb. 28, 2013, and 3 percent on Mar. 4 of that year.

The plaintiff alleged that Intuitive didn't properly file the MDRs to investors, misleading them into believing the company's forecast was strong despite the da Vinci defect.

While Judge Davila on Thursday tossed some claims in the securities class action, he said the plaintiff had sufficiently alleged that statements the company made over the safety and efficacy of the surgical equipment — while it was allegedly suppressing the MDRs — were misleading.

"Taking Plaintiff’s contentions as true, the court concludes that it is plausible that the reasonable investor would find the existence of these numerous unreported MDRs to significantly alter the total mix of information available and that defendants’ statements created an impression of da Vinci’s safety that materially differed from reality," the judge held-Law360, Los Angeles (August 22, 2014, 6:02 PM ET)
OUCH

 

First, I don't work for Intuitive.

If it is such a bad company and nobody likes them, why do I keep seeing new machines my accounts? Upgrades to Xi, new systems in accounts that had none, 2nd consoles for training, etc.

Robot neither helps nor hurts my business - interesting component of the O/R.

 

Why do you say it's a bad company? As a whole Intuitive has less product defects and recalls than any other device company. It's just that they're such a powerful stock, everyone hears of every little issue that is going on. Other device companies like Covidien and J&J are experiencing these same investigations and same MDR issues on the same if not higher level. Because Intuitive is in the news all the time, people think they are the only company facing these issues. That is far from the truth. The robot is a great tool, that is only get better w/ the advancements and refinements. As you mentioned, if it was so bad, your hospitals wouldn't be investing...

 

Hellooooo...marketing is the name of the game!

 

davinci is the PINTO. As for Intuitive being in the news a lot lately, one can only conclude that Intuitive has been aggressively marketing this PINTO ( PIG with lipstick is still a PIG ). People are are going to learn though the news that they should never trust this machine and that the builders didn't care about safety. Intuitive only cared about pushing sells and pushing cases that didn't have to happen.

"Apparently, surgeons don’t like to report problems with the Da Vinci system because they are afraid they will be blamed, and since the reporting system is voluntary for physicians, they don’t have to report. I can also tell you that the FDA never required any testing on human beings before they allowed the system to be sold. Instead, it was cleared for the market as “substantially equivalent” to scalpels and other surgical tools that were not part of a robotic system – which is obviously not an appropriate standard."---Diana Zuckerman, Ph.D. President National Center for Health Research

 

Pinto?! You're on crack. Open surgery is the pinto. Lap is the Honda, and da Vinci is the cadillac. I'm so tired of the marketing argument. Why is this "marketing" not working for any other device company?? Hospitals aren't stupid. They're not going to market something that they feel is unsafe, just to garner patients in the short term. Robotics is only going to further advance. How can you describe it as the pinto??

 

How can anybody say the DeVinci is like the Ford Pinto? EASY... The DeVinci is currently facing up to 1000 and counting lawsuits claiming it is unsafe. Intuitive is in globe resolution with 37 of the cases now. Like the PINTO, it KILLS and maims people! Just wait, on or near December 5, 2014 the other shoe will fall. Follow this case and watch and learn.

1-12-CV-237723: Zarick, et al. v. Intuitive Surgical, Inc.
Number: 1-12-CV-237723
Title: Zarick, et al. v. Intuitive Surgical, Inc.
Case category: Complex Litigation
Filing date: 12/12/2012

https://www.scefiling.org/cases/casehome.jsp?caseId=823

 

From reading this. The da vinci sure sounds like a Pinto.


Case: 1:14-cv-00225-MRB Doc 1 Filed: 03/12/14 Page: 1 of 46 PAGEID 1
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF OHIO
lows
I A. (7, li 9.2
ERIKA STARR Civil Action No.
1817 Bluefield Place, Apt. #1
Cincinnati, OH 45237
J. BARRETT
And
COMPLAINT AND
NICK GRIFFITH JURY TRIAL DEMAND
1817 Bluefield Place, Apt. #1
Cincinnati, OH 45237
Plaintiffs,
r-
V.
IN) i'41731,
INTUITIVE SURGICAL, INC.


Plaintiffs, Erika Starr and Nick Griffith, by and through Counsel, hereby state their
Complaint against Defendant Intuitive Surgical, Inc. as follows:
THE PARTIES
1. Plaintiff, Erika Starr, is a resident and citizen of Cincinnati, Hamilton County, Ohio.
2. Plaintiff, Nick Griffith, is a resident and citizen of Cincinnati, Hamilton County, Ohio.
3. Plaintiffs are a lawfully married couple and have three minor children.
4. Plaintiff, Erika Starr was 38 years of age at the time she sustained her injuries.
Case: 1:14-cv-00225-MRB Doc 1 Filed: 03/12/14 Page: 2 of 46 PAGEID 2
5. Plaintiffs are residents of Hamilton County, Ohio and are entitled to collect damages are
a foreseeable result of Defendant Intuitive Surgical, Inc.'s (hereinafter "INTUITIVE")
conduct.
6. Defendant INTUITIVE is a foreign business corporation, duly organized and existing
under and by virtue of the laws of the State of Delaware with a principal place of
business in the State of California at 1266 Kifer Road, Building 100, Sunnyvale, CA
94086-5304. Its registered agent for service is CT Corporation System, 450 West
Market, Suite 800, Indianapolis, Indiana 46204.
JURISDICTION AND VENUE
7. At all times material to this Complaint, Defendant conducted and transacted business
within the State of Indiana and in Hamilton County, by advertising, soliciting, selling,
promoting, and distributing da Vinci Robotic Surgical System to hospitals, healthcare
facilities, healthcare systems, healthcare providers, and ultimately to consumers,
including Plaintiffs Heather and Matthew Bays.
8. Jurisdiction is conferred on this Court by the provisions of 28 U.S.C. 1332 (a), et seq.,
by virtue of diversity of citizenship where the matter in controversy, exclusive of interest
and cost, exceeds $75,000.00.
9. Venue is appropriate in the Southern District of Indiana because the acts of negligence
and the injuries sustained as a result of the negligence took place in Hamilton County
within the State of Indiana.
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FACTUAL ALLEGATIONS
A. Nature of the Case
10. Plaintiffs, Erika Starr and Nick Griffith, bring this case against Defendant INTUITIVE
for damages associated with the use of the da Vinci Surgical System and its
iinstrumentation,ncluding but not limited to, the Monopolar Curved Scissors.
Specifically, as a direct result of the use of the da Vinci S Surgical System and its
instrumentation, including the Monopolar Curved Scissors on or about March 13, 2013,
Plaintiffs suffered physical and emotional injuries, including Plaintiff Erika Starr
suffering a bowel perforation and/or thermal burns and subsequent infections that caused
severe and permanent injuries, serious physical and mental pain and suffering, medical,
hospital and surgical expenses, lost wages, and the impairment to earn money.
B. da Vinci Surgical System
11. Defendant INTUITIVE is a Delaware corporation with its principal place of doing
business in Sunnyvale, California.
12. Defendant INTUITIVE is a publically traded company on the NASDAQ exchange, with
a current market value of more than two billion dollars.
13. On its website Defendant INTUITIVE asserts that it is the global technology leader in
surgical robotic products and promotes and advertises its products extensively.
14. Defendant INTUITIVE designed, manufactured, tested, marketed, distributed and
aggressively sold, promoted and labeled the da Vinci 8 Surgical System and its
instrumentation, including but not limited to, the Intuitive Surgical EndoWrist Instrument
Hot Shears Monopolar Curved Scissors (hereinafter "Monopolar Curved Scissors") to
hospitals, healthcare facilities, healthcare systems, including but not limited Christ
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Hospital, healthcare providers and ultimately to consumers, including Plaintiffs Erika
Starr and Nick Griffith, in the State of Ohio.
15. Defendant INTUITIVE is the holder ofthe U.S. Food and Drug Administration
(hereinafter "FDA") approved medical device, the da Vinci 0 Surgical System and its
iinstrumentation,ncluding the Monopolar Curved Scissors.
16. The da Vinci 8 Surgical System as manufactured by Defendant INTUITIVE is used to
perform surgery, including cardiac, colorectal, general, gynecology, head and neck,
thoracic and urology surgery throughout the United States, including in the State of Ohio.
17. At all relevant times, Defendant INTUITIVE performed pre and post market medical
device surveillance in connection with the reporting of complaints and adverse events
associated with the use of the da Vinci 8 Surgical System and injuries and deaths that
patients received while having surgery with the da Vinci 0 Surgical System.
18. Defendant INTUITIVE has promoted its device as (a) safe and (b) safer than other
comparative methods of surgery including, in the case of traditional laparoscopy and/or
laparotomy.
19. The defects in Defendant INTUITIVE's products were inherent and existed at the time it
left the Defendant INTUITIVE's facilities.
20. Defendant INTUITIVE utilizes prominent websites aimed at consumers, seeking to
create demand and assurances for the use of its robotic device by patients who consult
surgeons.
21. Defendant INTUITIVE sold its device through a calculated program of intimidation and
market management, forcing hospitals and physicians to purchase it in order to appear to
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be competitive, and creating a fear in their minds that if they did not have this technology
they would lose business to competitors.
22. Defendant INTUITIVE reinforced its calculated program, as stated in the preceding
paragraph, by placing, on its website for potential patients, names of certain physicians
who had performed surgeries with this device.
23. Hospitals have paid in excess of $1.5 million dollars for the product, and more than 2,500
such machines have been marketed and sold by Defendant INTUITIVE and Defendant
INTUITIVE has sold five (5) year maintenance contracts at a cost of approximately
$100,000 per year per machine, and the da Vinci Surgical System has been used in
over 400,000 surgeries.
24. On or about August 5, 2011, Defendant INTUITIVE submitted a Special 510(k) Device
Modification for the Monopolar Curved Scissors Tip Cover Accessory, the description of
which is, "an electrically isolating sleeve that is placed over the distal tip of the
Monopolar Curved Scissors. The Tip Cover Accessory acts to isolate the metal parts of
the instrument so that only the intended electrode (the scissor blades) is exposed for
surgical application."
25. On October 7, 2011, the FDA responded to Defendant INTUITIVE's Special 510(k)
Device Modification for the Monopolar Curved Scissors Tip Cover Accessory and
permitted Defendant INTUITIVE to market the device.
26. In October 2011, as a response to complaints and medical device reports for arching
through damaged tip covers that caused patient injuries, Defendant INTUITIVE initiated
a field correction by sending letter to da Vinci Surgical System clients with suggestions
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and recommendation for the proper use ofthe Tip Cover Accessory and for the correct
generators that should be used with monopolar instruments.
27. In October 2011, Defendant INTUITIVE initiated a separate field correction by sending
letters to da Vinci Surgical System clients with information for inspecting the
instrument cannulas, proper flushing of the instruments and proper transportation of the
da Vinci 8 Surgical System between buildings.
28. In September 2012, Defendant INTUITIVE revised its medical device reporting
practices, resulting in increased reports of device malfunction reports and
administratively changed how medical device reports previously reported as adverse
events were subcategorized resulting in an increase in events in the "serious injury"
category.
29. Between 2011 and 2012, there was a spike in the number of adverse event reports filed
with the FDA's Manufacturer and User Facility Experience (MAUDE) by 34% and
during the same time period there was an increase with the number of procedures using
the da Vinci 8 Surgical System by 26%.
30. As of January 2013, Defendant INTUITIVE submitted additional 500 medical device
reports to the FDA increasing the additional injuries and deaths reported.
31. As of January 2013, there were over 4,600 adverse events reported in the MAUDE
database with the FDA, some of which contained information concerning patient injuries
and deaths.
32. In January 2013, after an increase in adverse event reports and injuries, the FDAasked.
surgeons whose hospitals belong to the agency's Medical Product Safety Network to
participate in a survey about the da Vinci Surgical System. Surgeons were asked about
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user training, common equipment errors, patient selection and the complications they
endured and how the complications with the da Vinci 0 Surgical System compared with
conventional surgeries, and what procedures are the best and least suited for the da Vinci
8 Surgical System.
33. In March, 2013, the American College of Obstestricians and Gynecologists [hereinafter
"ACOG"] declared, "Expertise with robotic surgery is limited and varies widely among
hospitals and surgeons". ACOG further declared, "Studies have shown that adding this
expensive technology [da Vinci 8 robotic surgery] for routine surgical care does not
improve patient outcomes. Consequently, there is no good data proving that robotic
surgery is even as good as let alone better than existing, and far less costly, minimally
invasive alternatives."
34. In March, 2013, ACOG concluded its statement, "Aggressive direct—to—consumer
marketing of the latest medical technologies may mislead the public into believing that
they are the best choice. Our patients deserve and need factual information about all of
their treatment options, including costs, so that they can make truly informed healthcare
decisions. Patients should be advised that robotic surgery is best used for unusual and
complex clinical conditions in which improved outcomes over standard minimally
invasive approaches have been demonstrated."
35. In March 2013, the Board of Registration in Medicine, Quality and Patient Safety
Division in the Commonwealth of Massachusetts issued an Advisory on Robot-Assisted
Surgery making recommendations on:
a. Training, proctoring and assessment of proficiency with robotic surgery;
b. Patient selection and risk assessment;
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c. Informed decision making and noted that "Careful attention should be paid to the
influences of direct to patient marketing and other factors that may introduce
different dynamics into the patient selection process;" and
d. Perioperative considerations.
36. Prior to March 13, 2013, Defendant INTUITIVE was aware that patients had sustained
bowel perforations, injuries and/or thermal burns and other injuries during the use ofthe
da Vinci 8 Surgical System and its instrumentation.
37. Prior to March 13, 2013, Defendant INTUITIVE was aware that patients with adhesions
were at an increased risk to suffer bowel perforations when having surgery with the da
Vinci 0 robotic surgery and/or that intra-abdominal adhesions were a relative and/or
absolute contraindication to having surgery via the da Vinci 8 robot.
38. On March 13, 2013, Plaintiff Erika Starr had an exploratory laparoscopic da Vinci
robotic surgery that included the removal of a left retroperitoneal cyst at Christ Hospital.
39. On or about April 19, 2013, Defendant INTUITIVE recalled the monoplar scissors
because the instruments "may develop micro-cracks near the distal (scissor) end ofthe
shaft following reprocessing. This may create a pathway for electrosurgical energy to
leak to tissue during use and potentially cause thermal injury.... These micro-cracks may
not be visible to the user."
40. On or about April 26, 2013, the FDA announced that it had launched an investigation into
Defendant INTUITIVE and its medical device, the da Vinci 8 Surgical System.
41. On or about May 2013, Defendant INTUITIVE started shipping a new revised version of
the Monopolar Curved Scissors.
8
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42. On July 16, 2013, the FDA issued a warning letter to Defendant INTUITIVE stating that
Defendant INTUITIVE failed to do the following, including but not limited to:
a. Notify the FDA of the field correction letters Defendant INTUITIVE sent out to
da Vinci 8 Surgical System Clients in October 2011 concerning the monopolar
scissors;
b. Notify the FDA of the field correction letters Defendant INTUITIVE sent out in
October 2011 to da Vinci 8 Surgical System clients concerning thyroidectomies
indications not being cleared;
c. Notify the FDA of the field correction letters that Defendant INTUITIVE sent out
in October 2011 to da Vinci 8 Surgical System clients concerning the inspection
of the instrument cannulas, proper flushing and transportation ofthe da Vinci 0
Surgical System between buildings;
d. Take appropriate action despite having knowledge that patient injuries associated
with intraoperative cleaning of energized instruments such as the Monopolar
Curved Scissors and Fenestrated Bipolar Scissors.
43. Plaintiffs were advised that Plaintiff Erika Starr needed to have da Vinci 8 robotic
surgery.
44. Plaintiffs were presented with information promoting the benefit of a da Vinci 8 robotic
surgery over all other methods of surgery. Specifically, Plaintiffs were informed that due
to the da Vinci 8 robotic approach Erika Starr would heal faster, have a better outcome
and have less pain.
45. Based on representations made and information provided to her, the Plaintiff agreed to
proceed with the da Vinci robotic surgery.
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46. During her da Vinci robotic surgery on March 13, 2013, PK gyrus bioPolar grasper, a
Prograf grapser and Monopolar Curved Scissors manufactured and distributed by
Defendant INTUITIVE were used intraoperatively.
47. Plaintiff Erika Starr's surgery on March 13, 2013 resulted in her suffering a thermal
injury and/or perforation to her small bowel, peritonitis, sepsis, pulmonary embolus,
pericardial effusion and bilateral pleural effusions and additional surgeries, care and
treatment, prolonged hospitalization and increased medical expenses, loss of wages, and
loss of enjoyment of life.
48. Plaintiff continues to suffer from chronic abdominal pain, severe abdominal issues and
other issues. Through this time period Erika Starr has been unable to maintain normal
relationships and responsibilities and was totally dependent on her husband, Nick Griffith
and she has suffered emotional distress and was unable to work for a period of time.
49. The use of Defendant INTUITIVE's robotic device in surgery presents substantial risks
of complications and injuries, including, but not limited to, ureter injuries, thermal burns,
de-vascularzation of the vaginal cuff impeding healing, partial thermal injury burns to
bowel, post-surgical abscesses, tears, bleeding, hematomas, sepsis, fistulas and otherwise.
50. More specifically, Defendant INTUITIVE's robotic device can cause damage to the
bowel, rectum, blood vessels, arteries, ureters, bladder and vaginal cuff.
51. On occasion these complications and injuries cause and/or contribute to infectious
processes from thermal injury causing abscess formation and can lead to excessive pain,
suffering and permanent emotional and physical disability.
52. Defendant INTUITIVE has been aware and was aware long before March 13, 2013 of the
aforesaid risks and complications associated with the use ofthe da Vinci Surgical
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System and the Monopolar Curved Scissors and its other assessories and has failed to
take proper precautions including failure to make property notifications to hospitals,
patients, doctors and the FDA.
53. Defendant INTUITIVE did not provide adequate warnings to physicians and patients
about the risks and complications associated with the use of its robotic device, including
but not limited to advising healthcare providers such as Dr. Marcia Bowling and Dr.
Aparna Dacha of the increased risks of bowel perforations with patients with adhesions
and/or the relative and/or absolute contraindication of the use of the da Vinci robot for
surgery for patients with adhesions.
54. Defendant INTUITIVE has not done, nor sponsored any testing as to long-term outcomes
in comparison to other surgical and laparoscopic methods.
55. Defendant INTUITIVE had not revealed timely, through publications or reports to the
FDA and other governmental bodies, the true extent of complications and injuries, which
then known to have been occurring in actual practice.
56. Defendant INTUITIVE had been suppressing reports and complaints of complications
and performance errors due to the use of its said device prior to Plaintiff s suigery.
57. Defendant INTUITIVE does not adequately train physicians nor proctor them properly
on the use of its device, thereby inducing them to cause complications and injuries, which
would be avoided in the hands of properly trained physicians.
58. Defendant INTUITIVE represents that they will have skilled technicians in the operating
room or on emergency call in the event of problems arising with its said device, but often
has neglected to do so.
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59. Defendant INTUITIVE has aggressively over-promoted its device to hospitals,
physicians and the public, including potential consumers, combined with minimizing the
risks and complications associated with its use.
60. The da Vinci 8 surgical robot was defective in that it relied upon the use of monopolar
energy to cut, burn, cauterize tissue, whereas safer methods were available.
61. The device has inadequate insulation for its arms thereby allowing electrical current to
pass into tissue outside of the operative field thereby causing extensive injury.
62. The insulation on the shafts of the said device had becdme torn and worn in places,
without the awareness of the physician user allowing electrical current to pass into tissue
outside ofthe operative field causing damage.
63. Defendant INTUITIVE had failed to warn users and consumers of the said robotic device
about the inadequate insulation on the arms and the potential for electrical current to pass
into tissue outside of the operative field.
64. Due to design defects, Defendant INTUITIVE's devices had malfunctioned during the
course of operative use causing injury, requiring additional surgeries and procedures to
deal with complications of robotic use.
65. Defendant INTUITIVE had failed to warn users and consumers of its said device of the
design flaws stated in the preceding paragraphs, although it has reached out directly to
consumers to promote its asserted advantages.
66. Defendant INTUITIVE, in points of time, had specific knowledge and awareness ofthe
dangers of monopolar current and that there were safety modalities commercially
available that could have greatly diminished or eliminated some ofthese risks, yet the
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Defendant INTUITIVE elected not to include these safety features on the da Vinci 8
Robotic gynecology platform.
67. Defendant INTUITIVE had obtained and continued to maintain approval of the uses of
its device from the FDA by failing to fully inform them of its knowledge of risks and
complications associated with the use of its device.
68. As a direct result of Defendant INTUITIVE's conduct, Plaintiff Erika Starr has suffered
and has had extensive surgeries and injuries and will be need in all likelihood care and
treatment into the future.
FIRST CAUSE OF ACTION STRICT LIABILITY
69. Plaintiffs incorporate by reference each and every paragraph of this Complaint as though
set forth in full in this cause of action.
70. At the time of Plaintiff Erika Starr's injuries, Defendant INTUITIVE's da Vinci
Surgical System and its instrumentation, including but not limited to, the Monopolar
Curved Scissors, PK gyrus biopolar grapser, and/or the Prograf grasper were defective
and unreasonably dangerous to foreseeable consumers, including Plaintiff.
71. The da Vinci 8 Surgical System and its instrumentation, including but not limited to the
Monopolar Curved Scissors, PK gyrus biopolar grapser and/or the Prograf grasper were
in the same or substantially similar condition as it was when it left the possession of
Defendants.
72. Plaintiffs did not misuse or materially alter the da Vinci 8 Surgical System and/or its
instrumentation.
73. Defendant INTUITIVE is strictly liable for Plaintiffs' injuries in the following ways:
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a. The da Vinci 8 Surgical System and its instrumentation as designed,
manufactured, sold and supplied by Defendant, was defectively designed and
placed into the stream of commerce by Defendants in a defective and
unreasonably dangerous condition;
b. Defendant INTUITIVE failed to properly market, design, manufacture, distribute,
supply and sell the da Vinci Surgical System and its instrumentation;
c. Defendant INTUITIVE failed to warn and place adequate warnings and
instructions on the da Vinci Surgical System and its instrumentation, including
but not limited to the Monopolar Curved Scissors, PK gyrus biopolar grapser
and/or the Prograf grasper;
d. Defendant INTUITIVE failed to adequately test the da Vinci Surgical System
and its instrumentation, including but not limited to, the Monopolar Curved
Scissors PK gyrus biopolar grapser and/or the Prograf grasper;.
e. Defendant INTUITIVE failed to provide timely and adequate post-market
warnings and instructions after they knew ofthe risk of injury associated with the
use of the da Vinci Surgical System and its instrumentation, including but not
limited to, the Monopolar Curved Scissors; PK gyms biopolar grapser and/or the
Prograf grasper;
f. A Feasible alternative design existed that was capable of preventing Plaintiffs'
injuries.
74. Defendant INTUITIVE's actions and omissions were the direct and proximate cause of
Plaintiffs' injuries.
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75. Defendant INTUITIVE's conduct as described above, was extreme and outrageous.
Defendant INTUITIVE risked the lives of consumers and users of their products,
including Plaintiff's, with the knowledge of the safety and efficacy problems and
suppressed this knowledge from the general public. Defendants made conscious
decisions not to redesign, re-label, warn or inform the unsuspecting consuming public.
Defendant's outrageous conduct warrants an award of punitive damages.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
SECOND CAUSE OF ACTION NEGLIGENCE
76. Plaintiffs incorporate by reference each and every paragraph of this Complaint as though
set forth in full in this cause of action.
77. Defendant INTUITIVE had a duty to exercise reasonable care in the manufacture,
labeling, sale and distribution ofthe da Vinci 8 Surgical System and its instrumentation,
including but not limited to, the Monopolar Curved Scissors, PK gyms biopolar grapser
and/or the Prograf grasper; including a duty to assure that the product did not cause
unreasonable, dangerous injuries and/or deaths to patients.
78. Defendant INTUITIVE owed Plaintiffs a duty to exercise reasonable care when
designing, testing, manufacturing, marketing, advertising, promoting, distributing, and/or
selling da Vinci 8 Surgical Systems and its instrumentation for surgery.
79. Defendant INTUITIVE failed to exercise ordinary care in the manufacture, sale,
warnings, quality assurance, quality control and distribution of the da Vinci S urgical
System and its instrumentation in that Defendant INTUITIVE knew or shown have
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known that the da Vinci 8 Surgical System and its instrumentation created a high risk of
unreasonable harm.
80. Defendant INTUITIVE was negligent in the design, manufacture, advertising, warning,
marketing and sale of the da Vinci Surgical System and its instrumentation, including
but not limited to, the Monopolar Curved Scissors and violated R.C.§2307.74,
R.C. 2307.75, R.C. 2307.76, R.C. 2307.77 in that among other things Defendant:
a. Failed to use care in designing and manufacturing the da Vinci 0 Surgical System
its instrumentation so as to avoid the aforementioned risks to individuals;
b. Failed to accompany the da Vinci Surgical System and its instrumentation with
proper warnings regarding all possible adverse events including injuries and
deaths associated with its use, and the comparative severity and duration of such
injuries and/or the complications of deaths. The warning given did not accurately
reflect adequate instructions for use, potential complications, and potential known
hazards and design defects that Defendant INTUITIVE was aware ofprior to
March 13, 2013 associated with the use ofthe da Vinci Surgical System and its
instrumentation;
c. Failed to provide adequate training, proctoring and instruction to hospitals,
healthcare systems and medical care providers as to the appropriate use ofthe da
Vinci Surgical System and its instrumentation;
d. Placed unsafe products into the stream of commerce; and
e. Were otherwise careless or negligent.
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81. At all relevant times to this action, Defendant INTUITIVE owed a duty to properly warn
Plaintiffs, the healthcare community and the public of risks, dangers and adverse side
effects of the da Vinci 8 Robotic surgery platform as soon as it became known.
82. Defendant INTUITIVE breached its duty by failing to exercise ordinary care in the
preparation, design, research, testing, development, manufacturing, inspection, labeling,
marketing, promotion, advertising and selling of da Vinci 8 Robotic Surgery, as set forth
below:
a. Failing to test da Vinci 8 robot properly and thoroughly before promoting the
robotic surgical platform using monopolar energy and its instrumentation to the
market;
b. Failing to analyze properly and thoroughly the data resulting from the premarketing
tests of monopolar energy and its instrumentation used in the da Vinci
8 robotic surgery.
c. Failing to report to the FDA, the healthcare community, and the general public
those data resulting from pre-and-post marketing tests of the da Vinci 8 Robotic
surgery platform which indicated risks and relative and/or absolute
contraindications associated with the use ofthe da Vinci 8 robot;
d. Failing to conduct adequate post-market monitoring and surveillance of postsurgical
complications, including the complications ofbowel injuries, thermal
burns and adhesions associated with the da Vinci 8 robotic surgery using
monopolar energy and its instrumentation;
e. Failing to conduct adequate analysis of adverse event reports and data maintained
a conscious disregard for this data;
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f. Designing, manufacturing, marketing advertising, distributing and promoting the
da Vinci robotic surgery directly to consumers, including Plaintiff, without
adequate warning of the significant and dangerous risks of monopolar current and
the risks associated with the Monopolar Curved Scissors, PK gyms biopolar
grapser and/or the Prograf grasper and the da Vinci 8 robotic surgery and without
proper instructions to avoid the harm which could foreseeably occur as a result of
using monopolar energy and its instrumentations on the existing da Vinci 8
robotic surgery.
g. Failing to exercise due care when advertising and promoting da Vinci 8 robotic
surgery;
h. Negligently continuing to manufacture, market, advertise and promote da Vinci 0
robotic surgery after Defendant INTUITIVE knew or could have known ofthe
risks of serious injury and/or death associated with using monopolar current to
perform certain aspects of the surgery;
i. Failing to use due care in the preparation and development of the da Vinci 0
robotic surgery to prevent the aforementioned risk of injuries to individuals
through the use of monopolar current;
j. Failing to use due care in the design of the da Vinci 0 robot and its
instrumentation with special regard to the insulation of the robotic arms and
instruments to prevent the aforementioned risk of injuries to individuals during
the routine course of surgery;
k. Failing to conduct adequate pre-clinical testing and research to determine the
safety of the use of monopolar current and the insulation of the robotic
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instruments to be used in robotic surgery, with special regard to the reusing of the
instruments up to ten times in ten different patients;
1. Failing to conduct adequate pre-clinical testing and research and post marketing
surveillance to determine the safety of the da Vinci robotic and its instruments
to be used in robotic surgery with patients that have had previous abdominal
surgeries and/or in patients that have adhesions.
m. Failing to conduct adequate intra-operative surveillance and post-operative
complication studies to determine the safety of the use of monopolar energy
and/or proper use of its instrumentation during the surgical robotic surgery
procedure taught by Intuitive Surgical, Inc. while Defendant INTUITIVE knew or
should have known that intra-operative surveillance and post-operative
complication analysis would be the only means to determine the relative risk of
using monopolar when performing a robotic surgery causing severe thermal injury
to patients' bowel, in the absence of clinical trials which cannot be conducted for
this purpose, and that such surveillance would be necessary for a due diligence
program that would have altered Defendant INTUITIVE to the need to change the
technique for the use of monopolar current or to withdraw it from the market
altogether prior to this Plaintiff s surgery.
n. Failing to completely, accurately and in a timely fashion, disclose the results of
the pre-marketing testing of issues with monopolar energy and post-marketing
surveillance of monopolar energy, and the contraindications and increased risk for
patients with adhesions related injuries and complications to Plaintiff, consumers,
the medical community and the FDA.
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o. Failing to accompany marketing materials promoting the da Vinci robotic
surgery using monopolar current with proper warnings regarding all possible
adverse side effects associated with the use of the same;
p. Failing to accompany marketing materials promoting the da Vinci 8 robotic
surgery with proper warnings regarding all possible adverse side effects
associated with the use of the same, including but not limited to providing
warnings and contraindications for use and increased bowel injuries for patients
with prior surgeries and/or adhesions.
q. Failing to use due care in the manufacture, inspection and safety evaluation of the
da Vinci robotic surgery to prevent the aforementioned risk of injuries to
individuals who underwent a da Vinci 8 robotic surgery;
r. Failing to use due care in the promotion of da Vinci 8 robotic surgery to prevent
the aforementioned risk of injuries to individuals;
s. Failing to use due care in the promotion of da Vinci 8 robot to prevent the
aforementioned risk of injuries to individuals who were to undergo robotic
surgery;
t. Failing to use due care in the selling of the monopolar scissors to prevent the
aforementioned risk of injuries to individuals who underwent da Vinci 8 Robotic
Surgery;
u. Failing to provide adequate and accurate training and information to the sales
representatives who sold the da Vinci 8 Robot;
v. Failing to provide adequate accurate training and information to healthcare
providers for the appropriate use ofthe da Vinci Robot for surgery.
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w. Failing to conduct or fund research into the development of safer robotic surgical
instruments which would pose the least risk of causing severe thermal injury to
bowel, bladder, ureter and blood vessels;
x. Failing to educate healthcare providers and the public about the safest use ofthe
monopolar scissors and grasper instrumentation in da Vinci Robotic surgery;
y. Failing to give healthcare providers adequate information to weigh the risks of
serious injury and/or death for a given patient using the da Vinci Robotic
Surgery platform and technique featuring the use of monopolar current; and
z. Being otherwise reckless, careless and/or negligent.
83. Defendant INTUITIVE placed into the stream of commerce its aforesaid device, which
was defective in its labeling and warnings, as previously pleaded.
84. Defendant INTUITIVE placed into the stream of commerce its aforesaid device, which
was defective in its testing and approval, as previously pleaded and did not cause
notification to Plaintiffd and others similarly situated until long after it had knowledge of
the damages of the aforesaid robotic device and in this case not until after March 13,
2013 and after Plaintiff's surgical procedures.
85. At the time the device left the possession of Defendant INTUITIVE it was in an
unreasonably dangerous and defective condition for application for robotic surgery using
monopolar energy.
86. Despite the fact that Defendant INTUITIVE knew or should have known that the da
Vinci robotic surgery platform using monopolar current had increased the risk of
serious injury and/or death, Defendant INTUITIVE continued to promote and market the
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da Vinci robotic surgery to consumers, including Plaintiffs Erika Starr and Nick
Griffith, when safer and more effective methods of treatment were known to be available.
87. Defendant INTUITIVE designed, manufactured, packaged, marketed, distributed,
promoted and sold the da Vinci 8 Robot and its instrumentation, placing the da Vinci 8
Robotic Surgical system and its instrumentation into the stream of commerce.
88. The da Vinci 8 Robot was designed, tested, inspected, manufactured, assembled,
developed, labeled, sterilized, licensed, marketed, advertised, promoted, sold, packaged,
supplied and/or distributed by Defendant INTUITIVE in a defective and unreasonably
dangerous condition to consumers, including Plaintiffs.
89. The da Vinci 8 Robot was expected to reach, and did reach, users and/or consumers,
including Plaintiffs, without substantial change in the defective and unreasonably
dangerous condition in which it was manufactured and sold.
90. Plaintiff's surgeon used the da Vinci 8 robot for gynecology and general surgery
including monopolar current as instructed by and certified by and in the foreseeable
manner normally intended, recommended, promoted and marketed by Defendant
INTUITIVE. Upon information and belief, Plaintiff's surgeon attended a surgical lab for
hands-on initial training and were proctored for by a proctor employed by Defendant
INTUITIVE.
91. The da Vinci 8 gynecological and general surgery platforms were unreasonably
dangerous in that, as designed, it failed to perform safely when used by ordinary
consumers, including Plaintiff's surgeon, including when it was used as intended and in a
reasonably foreseeable manner.
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92. The da Vinci 8 robotic surgery was unreasonably dangerous, in that, as designed, the
risks of serious injury and/or death, including bowel, rectum, bladder, ureter, abscess
formation, permanent scarring or vascular injury, posed by its monopolar current risks
exceeded any benefit the robotic approach was designed to or might in fact bestow.
93. The da Vinci robotic surgery was unreasonably dangerous, in that, as designed, it was
dangerous to an extent beyond that contemplated by the medical community, and
ordinary patients, including the Plaintiffs.
94. The da Vinci 8 robot was defective in its design, in that, it neither bore nor was packaged
with, nor accompanied by, warnings adequate to alert the medical community, including
Plaintiff s surgeon, to the risks described herein, including, but not limited to, the risk of
serious injury and/or death, including bowel, bladder or vascular injury posed by its
monopolar current risks and the use of its instrumentation in general. The da Vinci 0
Robot was not accompanied by adequate labeling, instructions for use and/or warning to
fully apprise the medical, hospital, operating room and or scientific communities, and the
potential patients, including Plaintiffs, or the potential risks and serious side effects
associated with its use, thereby rendering Defendant INTUITIVE liable to the Plaintiff.
95. There were safer alternative energy modalities available including bipolar energy and
ultrasonic energy and traditional laparoscopic and/or laparotomy surgery available.
96. Monopolar energy, as used and taught on the da Vinci 0 robot, was unsafe for normal
reasonably anticipated use in performing surgery and removal of cysts.
97. In light of the potential and actual risk ofharm associated with the use of monopolar
energy so close to bowel, bladder, ureter, vaginal cuff and blood vessels, a reasonable
person who had actual knowledge of this potential and actual risk of harm would have
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concluded that the da Vinci robotic surgery platform should not have been marketed in
that condition.
98. Although Defendant INTUITIVE knew or should have known of the defective nature of
rts da Vzncl 8 robotic surgery platform using monopolar current, it continued to design,
manufacture, market and promote the use of its da Vinci 8 robotic surgery platform so as
to maximize sales and profits at the expense ofthe public health and safety. Defendant
INTUITIVE thus acted with conscious and deliberate disregard of the foreseeable harm
caused by the continued use of monopolar energy on its robotic platform.
99. Plaintiffs could not, through the exercise of reasonable care, have discovered the risk of
serious injury and/or death associated with and/or caused by the da Vinci robotic
surgery platform featuring monopolar current. Plaintiffs, if aware ofthese additional
risks could have chosen surgical procedures with similar efficacies but without these
additional risks. As a result, Plaintiffs suffered the injuries as described herein.
100. Information given by Defendant INTUITIVE to the medical community and to the
consumers concerning the safety and efficacy of the da Vinci 8 robotic surgery platform,
especially the information contained in the advertising and promotional materials, did not
accurately reflect the serious and potentially fatal side effects and consequences.
101. Had adequate warnings and instructions been provided, Plaintiff's surgeon and doctors
would not have suggested a robotic approach, and Plaintiff would have had a much lower
risk of the harmful side effects described herein and/or could have made an informed
judgment.
102. As a direct and proximate consequence of Defendant INTUITIVE's negligence, willful,
wanton, and/or intentional acts, omissions, misrepresentations and/or otherwise culpable
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acts described herein, the Plaintiffs Erica Starr and Nick Griffith sustained injuries and
damages alleged herein.
103. As a direct and proximate cause of Defendant INTUITIVE's negligence, among other
things, the Plaintiff Erica Starr suffered injuries which caused her to undergo additional
surgeries and medical procedures, medical expenses, endured pain and suffering and will
continue to do so in the future, lost wages, has suffered mental anguish and will continue
to do so in the future, has incurred medical expenses and loss of enjoyment of life.
104. Plaintiff has incurred and Defendant INTUITIVE is liable for certain expenses, including
hospital, surgical and medical treatment, transportation costs to various medical facilities
as a result of, among other things, loss of income, pain and suffering as a result of
Defendant INTUITIVE's conduct which was in conscious disregard of consequences.
105. As a result of its said conduct, Defendant INTUITIVE has become strictly liable to
Plaintiff.
106. Defendant INTUITIVE's conduct in continuing to market, sell and distribute the
aforesaid devices after obtaining knowledge and consciously disregarding they were
defective and not performing as represented and intended, showed complete indifference
to and/or a conscious, wanton disregard for the safety of others justifying an award of
punitive damages for aggravating circumstances in such a sum which will serve to deter
Defendant INTUITIVE and other from similar conduct in the future.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
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THIRD CAUSE OF ACTION NEGLIGENT TRAINING & PROCTORING &
NEGLIGENT CERTIFICATION
107. Plaintiffs repeat, reiterate and reallege each and every allegation and cause of action
contained herein as if the same were set forth more fully at length herein.
108. Defendant INTUITIVE was negligent and careless in the design, testing, manufacturing,
labeling and promotion of its aforesaid device, as pleaded in previous paragraphs.
109. In specific, Defendant INTUITIVE failed to warn users and consumers of the risk of
complications associated with the use of its said device in patients with adhesions and the
risks of monopolar current use, including the damage to the bladder, bowel, ureter,
vaginal cuff, and blood vessels; the bladder and ureter which was a proximate cause of
Plaintiff Erica Starr's additional surgery and medical treatments resulting in long term
pain and suffering.
110. Upon information and belief, Defendant INTUITIVE took it upon itself to "train" and
"certify" Plaintiff's surgeons on the use of the da Vinci 8 robotic surgery platform using
monopolar current. Upon information and belief, the Defendant INTUITIVE specifically
trained Plaintiff's surgeons on the use of monopolar energy and the monopolar scissors.
111. Upon information and belief, Defendant INTUITIVE did not properly proctor and/or
properly instruct Plaintiff's surgeons and attending staff as to the sage use of its device
nor how to detect complications which its said device causes and is known to cause.
112. Defendant INTUITIVE had a financial incentive to promptly train, proctor and certify
Plaintiff's surgeons without regard to whether or not Plaintiff's surgeons was truly skilled
and competent on the da Vinci robotic surgery platform.
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113. As a direct and proximate cause of Defendant INTUITIVE's negligence, among other
things, the Plaintiff Erica Starr suffered injuries which caused her to undergo additional
surgeries and medical procedures, medical expenses, endured pain and suffering and will
continue to do so in the future, lost wages, has suffered mental anguish and will continue
to do so in the future, has incurred medical expenses and loss of enjoyment of life.
114. Plaintiff has incurred and Defendant INTUITIVE is liable for certain expenses, including
hospital, surgical and medical treatment, transportation costs to various medical facilities
as a result of, among other things, loss of income, pain and suffering as a result of
Defendant INTUITIVE's conduct which was in conscious disregard of consequences.
115. Defendant INTUITIVE'S negligence was a direct and proximate cause of all of the
Plaintiffs' injuries.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
FOURTH CAUSE OF ACTION NEGLIGENT MISPRESENTATION
116. Plaintiffs repeat, reiterate and re-allege each and every allegation and cause of action set
forth herein as if the same were set forth more fully at length herein.
117. Prior to the da Vinci 8 surgical system and its instrumentation being used in Plaintiff
Erica Starr's surgery and after her surgery, Defendant INTUITIVE misrepresented that
the da Vinci 8 surgical system and its instrumentation were safe and an effective and had
medical benefits of shorten surgery time, less hospitalization time and fewer
complications than traditional laparoscopy and/or laparotomy surgery.
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118. Defendant INTUITIVE failed to disclose material facts regarding the safety and efficacy
of having a surgery using the da Vinci 8 surgical system, including information
regarding the increased adverse events and injuries, including thermal burns, lacerations,
perforations, bleeding, infections, additional surgeries and death.
119. Defendant INTUITIVE had a duty to provide Plaintiff Erica Starr's, physicians, and other
consumers with true and accurate information and warning of any known risks and
complications of the da Vinci 8 surgical system and its instrumentation that it marketed,
distributed and sold.
120. Defendant INTUITIVE knew or should have known, based on prior experience, adverse
event reports, studies and knowledge as to the risks, complications and safety failures
with the da Vinci 8 surgical system and its instrumentation and that it had a duty to
disclosure the dangers associated with the da Vinci 8 surgical system and its
instrumentation.
121. Defendant INTUITIVE made the representations and failed to disclose the material facts
with the intent to induce consumers, including Plaintiff Erica Starr to act in reliance on
undergoing surgery with the da Vinci 8 surgical system.
122. Plaintiffs justifiably relied on Defendant's representations and nondisclosures by
undergoing surgery with the da Vinci 8 surgical system.
123. As a direct and proximate cause of Defendant INTUITIVE's negligence, among other
things, the Plaintiff Erica Starr suffered injuries which caused her to undergo additional
surgeries and medical procedures, medical expenses, endured pain and suffering and will
continue to do so in the future, lost wages, has suffered mental anguish and will continue
to do so in the future, has incurred medical expenses and loss of enjoyment of life.
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124. Plaintiff has incurred and Defendant INTUITIVE is liable for certain expenses, including
hospital, surgical and medical treatment, transportation costs to various medical facilities
as a result of, among other things, loss of income, pain and suffering as a result of
Defendant INTUITIVE's conduct which was in conscious disregard of consequences.
125. Defendant INTUITIVE's misrepresentations and omissions regarding the safety ofthe da
Vinci surgical system and its instrumentation was the direct and proximate cause of
Plaintiffs' injuries.
126. Defendant INTUITIVE's conduct, as described above, was extreme and outrageous.
Defendant risked the lives of consumers and users of their product, including Plaintiff,
with the knowledge of the safety and efficacy problems and suppressed this knowledge
from the general public. Defendants made conscious decisions not to redesign, re-label,
warn or inform the unsuspecting consuming public. Defendant's outrageous conduct
warrants an award of punitive damages.
127. As a direct and proximate cause of Defendant INTUITIVE's negligence, among other
things, the Plaintiff Erica Starr suffered injuries which caused her to undergo additional
surgeries and medical procedures, medical expenses, endured pain and suffering and will
continue to do so in the future, lost wages, has suffered mental anguish and will continue
to do so in the future, has incurred medical expenses and loss of enjoyment of life.
128. Plaintiff has incurred and Defendant INTUITIVE is liable for certain expenses, including
hospital, surgical and medical treatment, transportation costs to various medical facilities
as a result of, among other things, loss of income, pain and suffering as a result of
Defendant INTUITIVE's conduct which was in conscious disregard of consequences.
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129. Defendant INTUITIVE'S conduct was a direct and proximate cause of Plaintiffs'
injuries.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
FIFTH CAUSE OF ACTION-FRAUD
130. Plaintiffs repeat, reiterate and re-allege each and every allegation and cause of action set
forth herein as if the same were set forth more fully at length herein.
131. Defendant INTUITIVE fraudently misrepresented the safety and comparative efficacy of
its device, upon which Plaintiff's surgeons relied, to Plaintiff's detriment.
132. Defendant INTUITIVE misrepresented the safety and comparative efficacy of its device,
upon which the hospital and surgery department where Plaintiff was operated on relied,
in purchasing and using the device to Plaintiff's detriment.
133. Defendant INTUITIVE was aware and/or should have been aware, of the known dangers
of monopolar current in regard to unsuspected current leaving the shaft of a poorly
insulted instrument. Furthermore, Defendant INTUITIVE suggested to hospitals that
multiple uses of the robotic instruments could be done yet Defendant INTUITIVE did so
without regard to re-testing of the insulation along the shaft of their robotic instruments
or at the wrist of the robotic instrument.
134. Defendant INTUITIVE was aware or should have been aware, of the known dangers of
monopolar current in regard to capacitive coupling, which like insulation failure can
cause a thermal injury to occur in adjacent structures like bowel, rectum, bladder, ureter,
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vaginal cuff, or blood vessel. Defendant INTUITIVE was aware and with conscious
disregard of the known increased incidence of ureter and other tissue damage as a result
of thermal burns, de-vascularization and abscess formation due to the use of monopolar
current while performing the da Vinci 8 robotic total laparoscopic surgery.
135. Defendant INTUITIVE was aware that there were safer energy modalities yet caused to
be maintained teaching and the use of the monopolar current in the da Vinci 8 robotic
surgery. Defendant INTUITIVE did so based on not wanting to pay for the cost of
having to license these safer energy technologies.
136. Defendant INTUITIVE was also aware or should have been aware of the Active
Electrode Monitoring System, or AEM Technology, which shields and monitors
instruments continuously directing stray energy, the cause of stray electrosurgical burns,
away from the patient. With the AEM system, the patient is never at risk for stray
electrosurgical burns due to insulation failure and capacitive coupling. Despite having
specific knowledge of this safety system the Defendant INTUITIVE chose not to
purchase it for the da Vinci 8 robotic surgery platform using monopolar current.
137. Defendant INTUITIVE concealed from consumers and users, including those mentioned
in the preceding paragraphs, and the risks associated with adhesions and other risks of
complications of which it was aware, which would have been material to consumers and
users in making the decision to use the said device.
138. Defendant INTUITIVE suppressed reports of adverse outcomes with the use of its
device, which would have been material to consumers and users in making the decision
to use the said device.
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139. Defendant INTUITIVE over-promoted its device and minimized the risks, for the
purpose of making sale of its device, its maintenance and the use of replaceable parts and
skewed the cost-benefit ratio inaccurately in its favor.
140. The said conduct was so willful, wanton, malicious and reckless that it merits the
imposition of punitive damages.
141. As a direct and proximate cause of Defendant INTUITIVE's fraud, among other things,
the Plaintiff Erica Starr suffered injuries which caused her to undergo additional surgeries
and medical procedures, medical expenses, endured pain and suffering and will continue
to do so in the future, lost wages, has suffered mental anguish and will continue to do so
in the future, has incurred medical expenses and loss of enjoyment of life.
142. Plaintiff has incurred and Defendant INTUITIVE is liable for certain expenses, including
hospital, surgical and medical treatment, transportation costs to various medical facilities
as a result of, among other things, loss of income, pain and suffering as a result of
Defendant INTUITIVE's conduct which was in conscious disregard of consequences.
143. Defendant INTUITIVE'S fraudulent conduct was a direct and proximate cause of
Plaintiffs' injuries.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
SIXTH CAUSE OF ACTION-FRAUDULENT CONCEALMENT
144. Plaintiffs hereby incorporate by reference all previous paragraphs of this complaint as if
fully set forth herein and further alleges as follows:
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145. Defendant INTUITIVE had the duty and obligation to disclose to Plaintiff and to her
physicians the true facts concerning the da Vinci robotic surgery platform, that is, that
the da Vinci robot was dangerous and defective and was likely to cause serious health
consequences to users, including injuries as described in this complaint.
146. Defendant INTUITIVE concealed important facts from Plaintiffs and from Plaintiff's
physicians which facts include, but are not limited to, that Defendant INTUITIVE had
received numerous adverse events reports of serious injuries and/or death, including
burns, tears, dehiscence, bleeding, hematomas, bowel injuries, sepsis and fistulas prior to
Plaintiff's surgery on March 13, 2013.
147. Defendant INTUITIVE made affirmative representations to Plaintiffs and her physicians
that the da Vinci 8 robotic surgery platform was safe as set forth above while concealing
the material facts set forth herein.
148. Defendant INTUITIVE had the duty and obligation to disclose to Plaintiffs and to her
physicians the true facts concerning the da Vinci robotic surgery platform which facts
include, but are not limited to, serious injuries and/or death including burns, tears,
dehiscence, bleeding, hematomas, bowel injuries, sepsis and fistulas prior to Plaintiff's
surgery.
149. At all times during the course of dealing between Defendant INTUITIVE and Plaintiffs,
and/or Plaintiffs' healthcare providers, and/or the FDA, Defendant INTUITIVE
misrepresentation the safety ofthe da Vinci Surgical System and its instrumentation.
150. At all times during the course of dealing between Defendant INTUITIVE and Plaintiffs,
and/or Plaintiffs' healthcare providers, and/or the FDA, Defendant INTUITIVE
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misrepresented the effectiveness and safety of the da Vinci 0 Surgical System and its
instrumentation.
151. Defendant INTUITIVE knew or were reckless in not knowing that its representations
were false.
152. In representations to Plaintiffs, and/or Plaintiffs' healthcare providers, and/or the FDA,
Defendant INTUITIVE fraudulently concealed and intentionally omitted the following
material information:
a. That the da Vinci Surgical System was not as safe as other forms of surgery;
b. That the risks of adverse events with the da Vinci Surgical System was higher
than other forms of surgery;
c That the risks and complications associated with the da Vinci 0 Surgical System
were not adequately tested and/or known by Defendant;
d. That Defendant was aware of dangers, injuries and deaths occurring to other
patients in otherwise routine surgeries when Defendant's product, the da Vinci 0
Surgical System was used;
e. That the da Vinci 0 Surgical System was defective and that it had
instrumentation, including but not limited to, the Monopolar Curved Scissors that
caused thermal injuries, burns, perforations, lacerations, bleeding, infections and
death;
f. That healthcare providers throughout the country were not all receiving the same
level of training and proctoring on the use ofthe da Vinci Surgical System;
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g. That Defendant intentionally sought to reduce the number of proctored surgeries
and the number of training hours of physicians before physicians operated on
patients;
h. That physicians needed to be monitored more and needed additional training,
including training on monopolar energy prior to operating with the da Vinci 8
Surgical System;
i. That the da Vinci 8 Surgical system and its instrumentation were manufactured
negligently;
j. That the da Vinci 8 Surgical system and its instrumentation were manufactured
defectively;
k. That the da Vinci Surgical system and its instrumentation were manufactured
improperly;
1. That the da Vinci Surgical system and its instrumentation were designed
negligently;
m. That the da Vinci 8 Surgical system and its instrumentation were designed
defectively; and
n. That the da Vinci 0 Surgical system and its instrumentation were designed
improperly.
153. Defendant INTUITIVE was under a duty to disclose to Plaintiffs and their physicians,
hospitals, healthcare providers, and/or the FDA the defective nature of the da Vinci 8
Surgical System and its instrumentation.
154. Defendant INTUITIVE had sole access to material facts concerning the defective nature
of its products and their propensity to cause serious and dangerous injuries and death and
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caused damage to persons who had surgery with the da Vinci 8 Surgical System,
including the Plaintiffs.
155. Defendant INTUITIVE intentionally, willfully, and maliciously concealed or suppressed
the facts set forth above from Plaintiff's physicians and Community Health Hospital and
therefore from Plaintiff with the intent to defraud as alleged herein.
156. Neither Plaintiffs nor her physicians were aware ofthe concealed facts set forth herein.
Had they been aware of those facts, they would not have acted as they did, that is, that the
da Vinci robotic surgery platform would not have been the chosen surgical modality of
Plaintiff and her physicians.
157. The Plaintiff was denied the right to be informed ofthe numerous adverse events
including serious injuries including burns, tears, dehiscence, bleeding, hematomas, sepsis
and fistulas associated with the da Vinci Robotic Surgery platform and Plaintiff would
have opted for a different surgical procedure if put on notice of adverse events known to
Defendant INTUITIVE.
158. As a proximate result of the concealment or suppression of the facts set forth above
Plaintiff and her physicians' reasonably relied on Defendant INTUITIVE's deception,
and Plaintiff underwent surgery utilizing the da Vinci robotic surgery platform and
subsequently sustained injuries and damages as set forth in this complaint. Defendant
INTUITIVE's concealment was a direct and proximate cause in causing all of Plaintiffs'
injuries as stated herein.
159. In doing the acts here alleged, Defendant INTUITIVE acted with oppression, fraud and
malice and Plaintiff is entitled to punitive damages in an amount reasonably related to
Plaintiff's actual damages and to Defendant INTUITIVE'S wealth and sufficiently large
36
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to be an example to others and to deter Defendant INTUITIVE and others from engaging
in similar conduct in the future.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
SEVENTH CAUSE OF ACTION-BREACH OF EXPRESS WARRANTY
160. Plaintiffs repeat, reiterate and re-allege each and every allegations and cause of action set
forth herein as if the same were set forth more fully at length herein.
161. Defendant INTUITIVE made express warranties of safety to the buyers and consumers of
the device utilized during Plaintiff Erica Starr's surgery, upon which the buyers and users
as agents of Plaintiff Erica Starr relied, to her detriment. Defendant INTUITIVE
expressly caused to be represented to the Plaintiffs, Erica Starr and Nick Griffith (and to
other consumers and the medical conmunity) that the da Vinci robotic surgery was
safe, efficacious and fit for its intended purposes that it was ofmerchantable quality, that
it did not produce un-warned of dangerous side effects and that it was adequately tested.
162. Defendant INTUITIVE breached expressed warranties with respect to the da Vinci
robotic surgery in the following ways:
a. Defendant INTUITIVE represented through its labeling, advertising, marketing
materials, detail persons, seminar presentations, surgeon training sessions,
publications, notice letters, and regulatory submissions that the da Vinci robotic
surgery was safe, and fraudulently withheld and concealed information about the
substantial risks or serious injury and/or death associated with using monopolar
current on the existing da Vinci surgery platform;
37
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b. Defendant INTUITIVE represented that the da Vinci 8 robotic surgery was a safe
and/or safer than alternative surgical methods, and fraudulently concealed
information which demonstrated that the da Vinci robotic surgery approach was
not safer than alternatives available on the market, and;
c. Defendant INTUITIVE represented that the da Vinci robotic surgery was more
efficacious than other alternative surgical methods, and fraudulently concealed
information that it was not more efficacious than alternative surgical methods.
163. The da Vinci 8 robotic surgery does not confirm to Defendant INTUITIVE's express
representations, because it is not safe, efficacious, has numerous serious un-warned of
side effects, causes severe and permanent injuries including death, and was not
adequately tested.
164. The da Vinci robotic surgery including the use of monopolar current did not perform as
safely as an ordinary physician, as an agent ofthe patient, would have expected when
used as intended or in a reasonably foreseeable manner.
165. Plaintiffs Erica Starr and Nick Griffith, and Plaintiff s surgeons and others in the medical
community relied upon Defendant INTUITIVE's express warranties, resulting in the
Plaintiff's da Vinci robotic surgery.
166. Plaintiff, after ascertaining through her own injuries that the da vinci 8 robotic surgery
violated express warranties, hereby supply notice to Defendant INTUITIVE of same
through the filing of this lawsuit.
167. By selling the said device, Defendant INTUITIVE made implied warranties of safety,
merchantable quality and fitness for use, which was breached when Plaintiffs were
injured surgery.
38
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168. As a direct and proximate consequence of Defendant INTUITIVE's breach of express
warranty and/or intentional acts, omissions, misrepresentations and/or otherwise culpable
acts described herein, the Plaintiffs sustained injuries and damages alleged herein.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.

181. It is inequitable and unjust for Defendant INTUITIVE to retain this money because the
Plaintiff did not, in fact, receive the safe and efficacious surgical procedure Defendant
INTUITIVE represented da Vinci robotic surgery to be.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE fof
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
TENTH CAUSE OF ACTION INFORMED CONSENT/FAILURE TO
WARN/INADEQUATE WARNINGS AND INSTRUCTIONS
182. Plaintiffs incorporate by reference each and every paragraph of this Complaint as though
set forth in full in this cause of action.
41
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183. Defendant INTUITIVE violated R.C. §2307.76 failed to properly obtain informed
Plaintiffs and failed to provide proper warnings, and/or provided inadequate warnings
and instructions to physicians, healthcare providers, healthcare facilities and hospitals and
consumers, including Plaintiffs of the risks associated with the use of the da Vinci 0
robotic surgical system within surgeries, including the use within surgery surgeries.
184. Defendant INTUITIVE knew or, in the exercise of reasonable care, should have known
about the risks associated with the da Vinci 0 surgical system and its instrumentation and
failed to properly inform Plaintiffs and failed to properly warn physicians, healthcare
providers and consumers, including Plaintiffs of the risks associated with the use of the
da Vinci 0 robotic surgical system and the design defects within the da Vinci robotic
instrumentation.
185. Defendant INTUITIVE failed to disclose these material risks to Plaintiffs and consumers,
including the risks of thermal burns, tissue damage, infections, post-operative
complications, additional surgeries and delayed healing.
186. Defendant INTUITIVE failed to provide post-marketing warnings, inadequate warnings
and/or instructions concerning the risk of injuries, including but not limited bowel
injuries, post-operative infections and additional surgeries and medical care and
treatment, that a manufacturer exercising reasonable care would have provided
concerning that risk, in light ofthe likelihood that the da Vinci 0 surgical robot and its
instrumentation would cause harm such as the harm suffered by Plaintiff and in light of
the likely seriousness of that harm.
42
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187. If Defendant INTUITIVE had disclosed such material risks, Plaintiffs would have sought
a different method of surgery including traditional laparoscopic surgery and would not
have sustained the injuries that Plaintiffs had endured.
188. Defendant INTUITIVE's failure to disclose these material risks was a direct and
proximate cause of Plaintiffs injuries.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
ELEVENTH CAUSE OF ACTION VIOLATION OF OHIO'S CONSUMER
PROTECTION ACT
189. Plaintiffs incorporate by reference each and every paragraph of this Complaint as though
set forth in full in this cause of action.
190. The State of Ohio prohibits unfair, false, misleading or deceptive acts or practices in trade
and commerce.
191. Plaintiff, Erica Starr had a surgery with the da Vinci Surgical System and suffered
ascertainable losses and injuries as a result of Defendant INTUITIVE's actions in
violation of consumer protection laws.
192. Unfair methods of competition or deceptive acts or practices that were prescribed by law,
including the following:
a. Representing that the goods or services have characteristics, ingredients, uses,
benefits or quantities that they do not have;
b. Advertising goods or services with the intent not to sell them as advertised; and
43
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c. Engaging in fraudulent or deceptive conduct that creates a likelihood of confusion
or misunderstanding.
193. Defendant INTUITIVE'S conduct was the direct and proximate cause of Plaintiffs'
injuries.
WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
TWELFTH CAUSE OF ACTION LOSS OF CONSORTIUM
194. Plaintiffs incorporate by reference each and every paragraph of this Complaint as though
set forth in full in this cause of action.
195. Plaintiff, Nick Griffith, at all times herein was the lawfully married spouse of Plaintiff,
Erica Starr.
196. As a direct and proximate cause of the negligence of Defendant INTUITIVE, Erica Starr
sustained injuries to her ureter, the abdomen and subsequent abscess and chronic
inflammation and scarring sustained by Erica Starr while undergoing a da Vinci
Robotic Surgery and the pelvis pain, formation of intra-abdominal abscesses, sepsis, and
pain, permanent scarring and the emotional consequences; Plaintiff and her husband have
been deprived the normal companionship, company, affection, regard, assistance,
comfort, personal relations and emotional stability from Erica Starr.
197. These physical and emotional consequences of the injuries have negatively impacted the
quality and caused undue hardship to that relationship.
198. Defendant INTUITIVE'S conduct was the direct and proximate cause of Plaintiffs'
injuries.
44
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WHEREFORE, Plaintiffs demand judgment against Defendant INTUITIVE for
compensatory, treble and punitive damages, together with interests, costs of suit, attorneys' fees
and all such other relief as the Court deems proper.
DEMAND FOR JURY TRIAL
Plaintiffs demand a trial by jury on all counts and issues contained herein.
GLOBAL PRAYER FOR RELIEF
WHEREFORE, Plaintiffs respectfully demand judgment against Defendant INTUITIVE
for the following relief:
1. Judgment against Defendant INTUITIVE for compensatory damages in excess of
the minimum dollar amount necessary to establish the jurisdiction of this Court, and for such
amount as a jury may find fair and reasonable as shown by the evidence;
2. Punitive damages;
3. Plaintiffs' attorney fees and costs herein expended;
4. Pre- and post- judgment interest at the lawful rate;
5. Trial by jury; and
6. Any and all other relief to which they may be entitled.
Respectfully submitted,
41i Aweil grnnifer awrence
e L. Gilday
THE LAWRENCE FIRM, P.S.C.
606 Philadelphia Street
Covington, KY 41011
(859) 578-9130
(859) 578-1032 facsimile
illawrence@lawrencefirm.com
algilday@lawrencefirm.com
Counselfor Plaintiffs
45
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And
Jennifer A. Moore
GROSSMAN & MOORE, PLLC
One Riverfront Plaza
401 W. Main Street, Suite 1810
Louisville, KY 40202
(502) 657-7100
(502) 657-7111 facsimile
imoore@gmMjurvlaw.coin
Counselfor Plaintiffs
Dated: March 12. 2013

 

5,374 adverse events were reported, including 455 patient injuries, 86 deaths, 3,933 device malfunctions and 19 recalls issued by the company; the events involved 109,709 devices and instruments on the market. And counting... How can these fuckheads who work for this shitty company sleep at night? Just find I imagin until one day they are kicked out for questioning the status qua. We can only hope some of the employees will stop drinking the boomsauce cool aid and help those they hurt.

 

and da Vinci is the cadillac. LOL lmao shit, I'll have some of that crack your smoking. fucking idiot. If it looks like a Pinto, and kills like a Pinto. Odds are it's a Pinto LMAO... fucking Intuitive hack!

 

When cutting and pasting case files, please leave out personal details of plaintiffs... I understand public record and all, but really uncool regardless...respect their privacy.

Not terribly familiar with the specifics, but I know that all surgery has risks, all companies have products that haven't worked as intended, and what can't be clear is what role does human error play (surgeons are human)?

 

Exactly! Let's post all the pending litigation on Covidien and J&J...

 

So over 5000 doctors are all making the same mistakes? That's like saying the drivers of the Ford Pinto where at fault for stopping to fast. Additionally, all driving comes with inherited risks. So, when the Ford Pinto gets hit from behind and BLEW up it wasn't the manufactures fault. That's just the inherited risk. The facts are stacking up against Intuitive. Telling critics to stop cutting and pasting will not eliminate the the problem. Nor will your argument hold water in court!

Go ahead people cut and paste. Intuitive seems to take issue with it. You'd be a fucking idiot to ignore the the message simply because it doesn't fit your internet etiquette.

 

Just to clarify- never said not to cut and paste, just politely asked not to reveal real peoples names and addresses... Admitting it was an oversight would go a long way in proving that you're a reasonable person, and not just someone with an axe to grind.

Also, I'm not an ISI person, since you seem to think they're the only ones who propose that surgeons may make mistakes.

Finally, if there's a defect, I agree it needs to be investigated (which I think the FDA recently completed without any specific findings against the robot) and the clinicians that make choices with their patients need to manage that risk. I really don't believe that marketing changes surgeon decision making, but even if it does, what kind of surgeon is moving forward with this device if it's so widely "known" that it's killing people? They have access to a lot more info about results than most people on this board. That makes no sense in so many ways I can't even comprehend how someone would think they'd risk their medical practice to market a hospital...

Anxiously awaiting your thoughtful response...(even though I think it will be pretty much the same as your others...)

 

As politically as one can be, I can only say that you are without all the facts. There is a defect in the DeVinci and the company knew about this even as they filed for their US Patent ( I'll copy and paste that too in a few minutes ).

Intuitive does not want to disclose this for legal and financial reasons, but the truth is coming out. I would like to direct you attention to the FDA. The FDA submitted a warring letter which discloses this defect and the meager attempt by Intuitive trying to clover this up by issuing a field correction without notifying the public, its customers, and the FDA. Which is a violation of Federal laws as you might not be aware of. Not to mention just down right unethical. (will maybe not for you.)

Again, if a manufacture is lying about how many adverse events occurred while saying their product is safe (which Intuitive has been admonished for.) Then Intuitive attempting to recalling there product without saying its a recall... How could a reasonable person not conclude that this product has a defect (Pinto)?

Now for the CUT and PASTE:

WARNING LETTER

July 16, 2013

VIA UNITED PARCEL SERVICE

Gary S. Guthart, President and CEO
Intuitive Surgical, Inc.
1266 Kifer Road, Bldg 100
Sunnyvale, CA 94086-5304

Mr. Guthart

During an inspection of your facility located at 1266 Kifer Road, Sunnyvale, CA between April 1, 2013 and May 30, 2013, and investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures computer controlled endoscopic surgical systems and associated accessories. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The inspection revealed that your da Vinci System IS1000, da Vinci System IS1200, da Vinci System IS2000, da Vinci System IS3000, Tip Cover Accessory, and Cannula 8mm Regular are misbranded devices under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that you failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR 806-Medical Devices; Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to the following:

Failure to submit a written report to FDA within 10 working days of any correction or removal of a device if the correction or removal was initiated to reduce the risk to health posed by the device or to remedy a violation of the act which may present a risk to health as required by 21 CFR 806.10(b).

Examples of these failures include but are not limited to the following:

1. In October 2011, Intuitive Surgical, Inc. initiated a field correction by sending letters to da Vinci Surgical System clients with suggestions and recommendations for the proper use of the Tip Cover Accessory and for the correct generators that should be used with monopolar instruments. This correction was in response to complaints and medical device reports (MDRs) for arcing through damaged tip covers that caused patient injuries. Though the field action was undertaken to reduce a risk to health posed by the device, you failed to report the field action to the FDA as required. Your report of this recall on April 19, 2013 has been classified by FDA as a Class II recall, Z-1425-2013.

2. In October 2011, Intuitive Surgical, Inc. initiated a separate field correction by sending letters to da Vinci Surgical System clients to notify them that the da Vinci Surgical Systems promoted for thyroidectomy indications is not cleared for that use. You are aware of complaints and MDRs related to thyroidectomies performed with the da Vinci Surgical System. Though the field action was undertaken to reduce a risk to health posed by the device, you failed to report the field action to the FDA as required. Your report of this recall on April 19, 2013 has been classified by FDA as a Class II recall, Z-1426-2013.

3. In October 2011, intuitive Surgical, Inc. initiated a separate field correction by sending letters to da Vinci Surgical System clients with information for inspecting the instrument cannulas, proper flushing of the instruments, and proper transportation of the da Vinci Surgical System between buildings. Though the field action was undertaken to reduce a risk to health posed by the device, you failed to report the field action to the FDA as required. Your report of this recall on April 19, 2013 has been classified by FDA as a Class II recall, Z-1428-2013.

4. In January 2013, Intuitive Surgical, Inc. initiated a field correction by sending letters and replacement user manual addendum titled “da Vinci, da Vinci S, and da Vinci Si Surgical Systems User Manual Addendum for Transoral Surgery (TORS) P/N 552003-02 Rev.B 2012.09” to da Vinci Surgical System clients. The replacement addendum includes changes to the types of patients and conditions for which da Vinci TORS is indicated, such as warning against use in pediatric patients. Though the field action was undertaken to reduce a risk to health posed by the device, you failed to report the field action to the FDA as required. Your report of this recall on April 19, 2013 has been classified by FDA as a Class II recall, Z-1424-2013.

We have reviewed your response dated June 7, 2013 and find it incomplete and inadequate. Your standard operating procedure titled Field Actions, document 853012, revision T indicates that all corrections, removals, and labeling reiterations will be reviewed with the local district recall coordinator or 3rd party expert. We are unable to assess the adequacy of this change as we cannot evaluate the extent of the information that will be submitted to the local FDA recall coordinator. Nor can we assess how you will implement this new requirement in your SOP.

In addition, Section 6.3 of your work instruction titled Regulatory Notifications, document 859179, revision F intended to be used after a determination is made to file a field correction/removal indicates that Class I and Class II actions are to be reported, and Class III actions will be directed to the Head of Regulatory Affairs. This work instruction appears to contradict your Field Actions SOP, document 853012, which indicates that all corrections, removals, and labeling reiterations will be reviewed with the local district recall coordinator or 3rd party expert.

The FDA has previously informed you of your firm’s correction and removal violations in an untitled letter dated February 19, 2008, and FDA 483 Inspectional Observations issued on December 20, 2002.


A follow-up inspection will be required to assure that your corrections and/or corrective actions are adequate and properly implemented.


The inspection also revealed that your da Vinci System IS1000, da Vinci System IS1200, da Vinci System IS2000, da Vinci System IS3000, Tip Cover Accessory, and Cannula 8mm Regular are adulterated devices under section 501(h) of the Act, 21 U.S.C. 351(h), in that the methods used in, or the facilities or controls used for its manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements for devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to the following:

Design input requirements were not adequately documented as required by 21 CFR 820.30(c). Specifically, you informed our investigator that you are aware of patient injuries associated with intraoperative cleaning of energized instruments such as the Monopolar Curved Scissors and Fenestrated Bipolar Scissors as evidenced by at least (b)(4) complaints and 82 MDRs during calendar years 2010 and 2011, and 15% of the MDRs reviewed by our investigator. You also informed our investigator that you are aware that cleaning instruments inside patients during surgery is a common practice and have included a label warning in the Instructions-for-Use (IFU) against the practice. When our investigator asked you to provide the design input documentation and design resolution of this known user need you failed to provide the requested documentation.

We have received your response dated June 7, 2013 and find your response to this observation inadequate. Your modification to section 8.1 of document number 823033, revision H in that you are concluding that the IFU adequately consider the known intraoperative cleaning of instruments and the associated risks without going through your design control processes. You response is also inadequate in that you do not provide a response to the root cause of this critical missing design input in your design documentation.


Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the awarding of contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your firm’s response should be sent to: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502. Refer to the Unique Identification Number 406661 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer Sergio Chavez at 510-337-6886.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.



Sincerely,
/S/
Elizabeth A. Kage
Acting District Director

 

with an axe to grind.

That's saying it mildly. I can assure you that I have a dog in this hunt. A loved one of mine has been maimed by this fucking PINTO.

 

Dear (Friend),

Thanks for your note and for trying to help your friend. I don’t know if you saw me quoted in the NY Times a while ago regarding the Da Vinci system, which research shows has a much higher rate of causing problems than has been reported. Apparently, surgeons don’t like to report problems with the Da Vinci system because they are afraid they will be blamed, and since the reporting system is voluntary for physicians, they don’t have to report. I can also tell you that the FDA never required any testing on human beings before they allowed the system to be sold. Instead, it was cleared for the market as “substantially equivalent” to scalpels and other surgical tools that were not part of a robotic system – which is obviously not an appropriate standard.

I can tell you is that the inadequate testing of potentially dangerous medical devices is the fault of Congress and companies like Intutitve, which have repeatedly pressured the FDA to not require human testing because it is too “burdensome” for device companies. (And Congress, in turn, gets lots of donations from device companies.) If you or others you know think this is outrageous, I can help you have your voices heard to try to turn this situation around. I hope you will consider joining our efforts, because until this situation is changed, millions of patients will continue to be harmed.

Sincerely,

Diana Zuckerman, Ph.D.
President
National Center for Health Research is our new name!
Formerly National Research Center for Women & Families
Cancer Prevention and Treatment Fund is our major program
1001 Connecticut Ave., NW, Suite 1100
Washington, DC 20036
202 223-4000

 

If that is you and you are truly a PHD posting on such a credible forum such as this, then I have a suggestion. Since your major program is Cancer prevention and treatment, why don't you go ask any, I mean ANY GYN oncologist or Urology oncologist about the safety and efficacy of the da Vinci robot. See what they say, considering about 80-90% of those specialist use the da Vinci for their cancer treatments. Ridiculous.

 

80% to 90% of cancer treatment Doctors use the DaVinci? Your drinking too much of Intuitive cool aid. In fact, try citing any creditable source for your outrageous claim.

According to Intuitive's web site more than 1,000 of the robotic systems are in hospitals across the country.


Now for the real facts:


Total number of procedures performed: 51.4 million
Number of selected procedures performed:
Arteriography and angiocardiography using contrast material: 2.4 million
Cardiac catheterizations: 1.0 million
Endoscopy of small intestine with or without biopsy: 1.1 million
Endoscopy of large intestine with or without biopsy: 499,000
Diagnostic ultrasound: 1.1 million
Balloon angioplasty of coronary artery or coronary atherectomy: 500,000
Hysterectomy: 498,000
Cesarean section:1.3 million
Reduction of fracture: 671,000
Insertion of coronary artery stent: 454,000
Coronary artery bypass graft: 395,000
Total knee replacement: 719,000
Total hip replacement: 332,000

Source: National Hospital Discharge Survey. 2013


There is no way mathematically Devinci is use 80 to 90 percent of the time. Fucking Intuitive HACK...