FDA Warns Intuitive Surgical Over da Vinci Surgical Robot Deficiencies

fda_warns_intuitiveAs a result of inspections in April and May, the U.S. Food and Drug Administration (FDA) sent a warning letter to Intuitive Surgical on July 17 about deficiencies in the da Vinci surgical robot system.

The FDA letter commented on the company’s failure to adequately report device corrections and patient adverse events, according to Bloomberg News. Adverse event reports, including as many as 70 deaths, have risen steadily since 2009. The da Vinci surgical robot’s safety and cost effectiveness have also been under scrutiny. In February, the FDA began surveying surgeons about their experiences with the robots.

“The FDA has clearly noticed and acknowledged Intuitive’s failure to disclose an increase in adverse events,” said Gary Falkowitz, managing attorney with Parker Waichman LLP. “Failing to disclose such issues is concerning.”

Bloomberg News reports that the da Vinci system, currently in use in more than 1,300 hospitals nationwide, has been the subject of lawsuits from patients alleging they were injured during surgeries with the da Vinci.

Cancer surgery, hysterectomies, and gall bladder removals are among the most common robotically assisted procedures, although the American Congress of Obstetricians and Gynecologists (ACOG) recently warned consumers not to let aggressive marketing overshadow the risks of robot-assisted surgery. The ACOG said there is no good evidence that procedures with the da Vinci surgical robot are as good as less invasive, cheaper alternatives. The Journal of the American Medical Association reported in February that hysterectomies performed robotically cost hospitals $2,189 more than hysterectomy surgery performed without the robot, without reducing complications.

At issue in some lawsuits against Intuitive is the adequacy of the training surgeons receive before they undertake robot-assisted procedures unsupervised. After 2006, Intuitive simplified and shortened the training process from the stricter requirements in its 2000 application to the FDA for device approval. The Massachusetts Board of Registration in Medicine issued an advisory in light of growing reports of injuries associated with the da Vinci. The Board advocates greater oversight for surgeons, and better information for patients about the risks. The Board cited examples of patients who had suffered bleeding, adhesions, and damage to the bowel and ureter.



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