Note to Intuitive management (from a stock market research group “Citron”):
“It is about time that Intuitive takes a step back from its aggressive sales and share repurchase practices. Use your money instead to establish proper training centers for surgeons.”
Here are just a few of the questions that stand out to us:
* Why is none of the injured during robot surgery “video” of the surgery being retained? (Video recording and storage too technical? Afraid a jury will see? Can’t send "the video" as part of the M.A.U.D. report to the FDA?)
* How can so many bowel punctures and burns be occurring in “highly routine” surgeries such as hysterectomy and prostatectomy?
* Why does the company insist on appending every injury and death record with one of it’s don’t blame us annotations, such as “no machine failure”, “no system errors”, “system functioned within specification” or “no anomalies detected during the surgery”, etc. ?
* Is death a reasonable risk factor from a routine cholecystectomy (gall bladder removal), one of the simplest and most routine surgical procedures?
*Why are patients with serious septic aftereffects of Da Vinci surgery discharged from the hospital, only to be readmitted to the emergency room in life threatening conditions?
Was it the "urgent medical devise notification 2955842-05-07-2013-05" (Recalled part)?
MMMMMMM
To date 2.5 Billion in stock buy backs... That sure can do so much more than inflate the stock so the executives can sell out... Insider trading may be legal... to a point... I.S. is missing the point... This company is gonna crash when they get sued. Some time this year they go to TRIAL. that's why they cashing out!
You reps will be called to testify. Why your not spill the beans now? You know I'm right... So take what you know to the victims attorneys and get even with the greedy pigs! Or not... and see what happens when they shut down and you looking clueless...
Intuitive Surgical had sent a Customer Safety Notice Letter in October 2011 to customers with Safety Recommendations and Suggestions to prevent this situation from occurring. The main bullet points from the letter to minimize this risk are:
*Avoid Instrument Collisions.
*Carefully Install the Tip Cover.
*Straighten wrist prior to removal.
*Inspect cannula prior to use.
*Do not exceed maximum monopolar cautery settings.
*Only use Validated ESUs.
*Be aware of critical anatomy in contact with the instrument.
*Change Tip Cover in cases with extended cautery use.
Each of bullet items listed above have detailed explanations in the letter.
My wife’s doctor could have used those instructions in August 2010 (they are one year 11 day’s late.) Also included in the letter was for them to use the “correct generators” that power the part in question. I wonder if my wife’s doctor had the “correct generator”? The FDA 483 report stated that the letter they sent: “was not part of the user needs (Safety Recommendations and Suggestions) included in the design…”
Intuitive Surgical Inc. made fraudulent representations to the FDA to obtain approval for a medical device and that, had Intuitive Surgical Inc. not made those misrepresentations, the FDA would not have approved the medical device and my wife would not have been injured.
What can the defense be? They will be SHUT DOWN soon...