Davinci- what a scam

The cords that connect the device have not been identified as an issue. Most likely, they started making their own cords or got them form an outside vendor. Nothing here. Move on

 

It appears they found another addition to their accessories portfolio, leading to additional revenue. They probably do not want to rely on another vendor to supply a necessary accessory, as in the event of a back order, customers using the da Vinci would have few other options.

 

Not so fast droid. whats the hurry. Lets ponder a bit.

They were using "a suppliers" cords for the monopolor energy device that plugs into the GENERATOR. They been having all kinds adverse events with Monopolar energy device. They said it was the insulation and wrong generators were being used in the RECALL.

Few months / year later....

Still having monopolar adverse events. ISIS gets a patent, submits 510(k) for NEW cords for the monopolar device. (like they did for the cannula)

NEVER INFORMING THE FDA (hospitals or Dr.'s) that "a suppliers" cords that ISIS said was "ok" is causing the insulation in the Monopolor devices to blow holes and in turn -injure or kill patients.

Call me crazy but we seen this movie before! Looks like a re-run to me.

Tell the FDA its the insulation and wrong generators. We can supply our own insulation at the plant. no problem. tell them it may be the incorrect generator used? That will make them think we know what we are doing and they will go away. no stoppage to our customers is what our goal is. The patients safety? Real low on our list right now. At the same time, lets copyright some cords and get them approved by the FDA ASAP.

Not telling ANYBODY that the cords that they use were "defective with the robot". They would like to tell their customers to not use the cords but seeing that those are the only ones approved by the FDA.... if we do... we have nothing to offer our customers. We look like stupid droids if we did that. Using the robot would stop until our new cords are made and approved?

To this day, without "warning of the dangers" of the old cords, some Dr.'s are still burning with them. I guess the sales rep has yet to replace the cords for those Dr.'s?

No big deal if the FDA found out right? Just issue more warning's. We didn't pay a dime in fines so far so... why not?

Are these things the FDA should examine? Is the FDA going to examine this issue and put two and two together?

Move on huh?
I don't think so. stupid droids.

DWAS
-Magnus

 

No need to call names there big fella. Enlightenment sometimes requires the ability to realize that there are people who do know more than you.

The cords for these devices are totally outside the operative field. They deliver the energy to the active electrode. They have in no way been implicated the problems identified with the DaVinci laser or any electrosurgical unit. In every case it is the active electrode that causes the burns.

Nothing here. Move on.

 

"They have in no way been implicated the problems identified with the DaVinci laser or any electrosurgical unit"

Did you test them? Did the FDA? Are we supposed to just take ISIS word for it? Can you show me some paperwork on that?

DWAS

 

The problems are with the active electrode. You have to have a basic understanding of what you're talking about. Obviously, to show you any citations on the active electrode (shears) being the issue would be fruitless. It's well documented. You're grasping at straws and refuse to listen to reason and fact. Not asking you to take Intuitive's word for it, as I don't work for Intuitive. One need only look art the facts. The FDA obviously hasn't tested anything, nor have they made an adequate response to the complaints they received. Could it be that they, like a lot of others realize that Insulation failure is one of the leading causes of injury in Laparoscopic surgery as well?

 

What's so hard to unerstand that the cord "in question" is outside of the operative field?

 

The operating field?

You ever see what happens to cables when to much current is passed threw it? If say there is not enough insulation in the cable? Or if you use the wrong size jumper cables on your car for example?

The wrong gauge wire in the cables perhaps? If the wiring is too small for the breaker size, then yes it's dangerous!

Wire is used to allow current to flow from one place to another. Most wires have insulation surrounding the metallic core. An electrical insulator is a material whose internal electric charges do not flow freely and, therefore, does not conduct an electric current. A perfect insulator does not exist, but some materials such as glass, paper and Teflon, which have high resistivity, are very good electrical insulators. Insulation exists because touching a bare wire could allow current to flow through a persons body (bad) or into another wire unintentionally.


DWAS
-Magnus

 

Magnus,

You're in way over your head here. Give up while you're ahead. The cable in question cannot burn internal organs. In case you didn't understand the first time: the cable in question is nowhere near the internal organs. Educate yourself. The liberation from stupidity can be pretty liberating!

 

Last I checked this is a public message board

A fake? Surely you're kidding. Has this person represented themself in any way? This coming from a group of people who have assumed cartoon character names and other nonsense and hijacked a board intended for industry employees. Further, they pass themselves off as experts in Surgical Technology, Surgical Procedure, Federal Regulations, FDA Compliance, just to name a few.

DWAS has done their share of making false statements and false criminal allegations based on their very limited knowledge of the law and the Federal Regulatory process.

We'll have to check with the board moderators to see if it was their intent to have this board used track people and prosecute them for exercising their right to free speech.

Would the Cafepharma moderators care to weigh in?

 

I know its not anywhere near the organs, duh.

If the cables wire gauge or insulators is incorrect for high frequency electricity the PRODUCT (monpolar shears and Bipolar foreps) plugged in... will be compromised. Like compromising the insulation in the the Monopolar and Bipolar Cautery Devices that were RE-CALLED.

I'm stupid?

I'm here because I'm trying to get questioned answered. From fellow DWAS or whoever can educate. 1st thing one needs to learn is what questions need to be answered. Then getting those answers from an unbiased educator are useful. You don't answer the questions. You are of no use to us here.

Your are the one who looks like a fool. seriously.

We always answer your questions honestly. Takes two to have an adult conversation.

You a nurse or a dr or what? Why the mystery droid? You say you not ISIS so... You just a droid who says big words most people don't use and ....you da man? Only a bomb dropper or what?

Kick rocks droid!
answer the questions!


DWAS
-Magnus

 

Good point Magnus!

Just answer the question!!!

DWAS

 

I'm so amazed how some people act on here and I'm not talking about DWAS.
I can see they just want answers & their voicing their anger. That's clear.

How they are treated sickens me. I've heard them called so many names it's ridiculous.
This is an anonymous website but let's watch how we treat people especially that have been through so much.

 

DWAS should watch they're name calling too! They can dish it out but not take it?

 

I'm sure they can take it, they've been through so much already. I'm just pointing out it makes you look bad.

 

You assume that all of these posts are from the same person. The beauty of an anonymous message board is I don't have to answer your questions or discuss my qualifications. Let's just say I've been around long enough to know my way around an OR and have been exposed to the credentialing process, product development process, surgeon consulting process & HIPAA regulations to feel comfortable.

You say you're here to be educated but when someone posts something that doesn't support your point of view, they're met with hostility, name calling & punk ass behavior. You only answer the questions you want to answer and most time your answers ae way off base. A little humility would go a long way when you're trying to garner support for your cause and gather facts that just might help you. I've yet to see you have an adult conversation with anyone including your little group of DWAS Members.

 

You're right we have.
Thank you!

 

I can take it.
I'm a strong women.
LUCKY TO BE ALIVE AFTER A DA Vinci.

 

We know you are!

 

What should happen to a company that lied about outcomes, lied about adverse effects and lied about recalls? What should happen to a company that knew they had an issue and continued to allowed a defective product to be used while doing nothing? Allowing people to be hurt, for money, what should we as people do? Should we call for accountability?


What has happened to other companies in the past that failed like Intuitive? PINTO read about that case.