FDA Warns Intuitive Surgical Over Da Vinci Robot Complications

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July 19, 2013 – This week, Intuitive Surgical received a letter from the FDA regarding problems with its da Vinci Robot. According to FDA inspection reports, Intuitive failed to submit device corrections and adverse events associated with the surgical robot. Safety and cost effectiveness of the device have recently come under intense scrutiny, as nearly 70 deaths have been linked to the da Vinci Robot since 2009 alone.

Da Vinci Robot Recall March 25, 2014: Intuitive Surgical has issued a nationwide recall for certain cannulae components used with the da Vinci Robot, due to the risk that the parts may be damaged during use and could be hard to replace. To date, at least one patient has experienced injuries that may have been caused by a damaged cannula, which occurred when the tube rotated and punctured the patient’s abdomen.

What’s the Problem?

One of the problems the FDA asked Intuitive to respond to was the finding that several da Vinci Robot device corrections hadn’t been adequately reported. FDA also said that Intuitive failed to advise surgeons about the need to clean the robot’s instruments after surgeries. The company has received several reports of arching of electrified surgical instruments, resulting in “…tears or holes in protective tip covers that led to arcing that in turn led to injuries to patients.”

Intuitive has admitted that surgeons may require up to 200 surgeries before they become proficient with the da Vinci Robot, which means that during the long training period, many patients will experience outcomes that are inferior to those that would occur with a fully trained surgeon. Da Vinci Robot Lawsuits allege that Intuitive failed to adequately train surgeons on proper use of the machine, thereby increasing the risk of severe health complications that could have been avoided.

Adverse health complications linked to the da Vinci Surgical Robot have been reported to include:

  • Surgical Burns to Arteries or Organs
  • Peritonitis (painful and tender inflammation of the lining of the abdomen)
  • Sepsis
  • Excessive bleeding
  • Burning of nearby organs including the intestines
  • Punctured blood vessels, organs or arteries
  • Burns and/or tears of the intestines
  • Severe bowel injuries
  • Punctured or cut ureters
  • Vaginal cuff dehiscence (reopening of the incision made to remove the uterus and cervix during a hysterectomy)
  • Additional Surgical Procedures Following Robot Surgery
  • Wrongful Death

In April 2013, a lawsuit was filed against Intuitive in the U.S. District Court for the Eastern District of Louisiana by 15 individuals who claim to have experienced adverse health complications after undergoing procedures that utilized the da Vinci robot. The suit alleges that Intuitive manufactured a fundamentally defective medical device, and made false and misleading statements about its safety and effectiveness.

“Due to design defects, [da Vinci robots] have malfunctioned during the course of operative use causing injury, including the necessity of converting the procedure into open surgery, or often requiring subsequent surgeries to deal with complications of robotic use,” read the the complaint. “[Intuitive Surgical] has failed to warn users and consumers of its device of the design flaws…, although it has reached directly to consumers to promote its asserted advantages.”

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