How to target EES Xcel Recall

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Anonymous

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I'm sure all of you guys have heard that the EES Xcel trocar has been recalled. I'm a rather new rep and wondering how you guys will position this to your hospitals to get them to trial or use ours during the recall?

Thanks for any help.
 


This one isn't going to be too hard. Simply tell the OR materials manager that you have a solution for the broken Xcel trocar. Explain that the Xcel has been broken for some time and that the docs have been unwitteningly using it, and that you'd like the chance to have them use our bladeless trocars while EES fixes their broken ones. During those 3-4 weeks that the Xcels are gone, be in every case, and make sure you tell every laparoscopist that the Kii has been reliable for years and it's never been recalled and costs half as much. Focus on the fact that Xcel (in its current, broken format) has been used for years at the sake of the patient's safety. By the time Ethicon gets the Xcel fixed, we should have already gained a good chunk of the business. After that, there will be very little going back to Xcel.
 










Does anyone know the reason for the recall? The bladeless trocars have been recalled at least 3 times over the past 10 years. My guess, it is something to do with the plactic 'blade' falling off in the patient...but I do not know for sure.
 


Anonymous said:
Does anyone know the reason for the recall? The bladeless trocars have been recalled at least 3 times over the past 10 years. My guess, it is something to do with the plactic 'blade' falling off in the patient...but I do not know for sure.
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Failure mode is extreme leakage. Everything is fine until the scope has been inserted for an hour, and then when readjusted can't seal well again.
 


We are already well on our way to getting back to regular production of these ports and although this has been a difficult time for us, I'd like everyone to understand that we are made of tougher stuff than most people seem to realise. We will learn, improve and grow as a result of this recall. It's no surprise that you are all enjoying having a go at us, I completely understand. You won't admit it but deep down you probably respect the fact that we did the right thing for our customers even though it hurt.

EES is a large system of intelligent people who work very hard to get things right for our customers. We clearly made some mistakes here but we are collectively too strong not turn this around.

By the way.... don't think you are immune to this kind of problem. Anyone can have a bad day.

Calm down!
 


Anonymous said:
By the way.... don't think you are immune to this kind of problem. Anyone can have a bad day.
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The duckbill was modified so that a relief where the cap system seals was removed, this caused the seal between the cannula and cap to be lost if the cap was pushed. Engineers rushed the testing to avoid a simple 1 hour test. Management and quality systems didn't call them on it. Applied does not cut corners by skimping on testing, and is always challenging itself to improve it's methods.

The bigger disaster is the lack of root cause discovery from all the returns that were happening. There is a whole group of people tracking returns, monitoring trends and looking at specific failure modes. To not ring bells until 8 months after a major design is released is another major system break down far worse then a design failure. Applied calls meetings with senior management within 24 hours of a production supervisor finding something potentially non-conforming.


Over the thumb about 400,000 defective trocars were shipped because of these three system failures. Engineering, quality systems, and management. Systems fail when the culture & processes are not a good fit for the need. This is not an isolated random event - it is the cause of system break down. You can be intelligent and even driven to die for your company - but you can still lose the war if your philosophy and culture are wrong.

EES will adapt, you will have to. If the changes will be right, enough or fast enough; only time will tell. Applied looks forward to the challenge, it will only make us stronger.
 




"Lost" to Applied 2 years ago due to cost savings. I now have 150% of what I "lost" at list price. Great product guys, keep it up. I'm winning back surgeons (and blowing out my number) one by one because of your shitty product.

I love Applied!
 





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