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.”
READ MORE da Vinci Surgical Robot LEGAL NEWS
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.