FDA Sends Letter to Intuitive Surgical Over DaVinci Surgical Robot

Washington, DCThe Food and Drug Administration (FDA) has notified Intuitive Surgical, the makers of the daVinci surgical robot, that it violated federal procedures by warning its customers of problems associated with the devices, without first alerting the federal agency.

According to the FDA “483” letter, between January 2010 and December 2011 Intuitive received 134 complaints and filed 83 medical device reports related to "tip cover issues." Then, in October 2011, Intuitive issued its customers a letter with "suggestions and recommendations for the proper use of instruments with tip covers and for the correct generators that should be used with monopolar instruments." According to the FDA letter, this “correction” was in response to complaints regarding "arcing through damaged tip covers that caused patient injury." However, Intuitive failed to notify the FDA in advance of sending the letter out.

Arcing occurs when electrical currents jump inside someone during a surgery. CNBC Investigations has produced a documentary on this, entitled “The Da Vinci Debate.”

CNBC reports that some 450,000 people underwent robot-assisted surgery in 2012. More questions are being raised about the safety of the DaVinci robot and the possibility of a DaVinci robot injury as more lawsuits are being filed against the maker of the surgical robot. Although the robot’s maker says it stands behind the safety of the device, some patients say they suffered serious injuries because of the DaVinci robot.

MSN News has reported (6/18/13) that at least one woman reportedly suffered terrifying injury after a robot surgery for a hysterectomy. The patient says her small bowel fell out of her vagina five weeks after her hysterectomy. She reportedly filed a lawsuit against Intuitive Surgical Inc, maker of the robot, in December 2012.

Other injuries that DaVinci robot surgical patients complained about were burns and perforated intestines, but there could be other complications that have gone unreported or underreported.