Every year thousands of people go through robot-assisted surgery for a variety of procedures.
Many medical professionals and hospitals believe that robotic surgery is a cost effective and more efficient way to perform minor surgery. This has made robotic surgery quite popular. Intuitive Surgical, the maker of da Vinci robotic surgery devices, is credited with producing the most popular machines.
Although many hospitals across the country have embraced this technology emerging evidence seems to suggest that something could be wrong with this device.
The Food and Drug Administration (FDA) has disclosed that the device maker broke various procedures since it warned clients of the problems linked to the machine without first notifying regulators. The FDA claims that Intuitive received 134 complaints and filed 83 medical device reports between January 2010 and December 2011 all related to damaged tip covers that have resulted in patient injury after the surgery.
In October 2011 the company sent letters to customers with recommendations regarding the proper use of tip covers as well as correct generators that should be used in its Endo Wrist Monopolar Scissors. The corrections were in response to complaints about "arcing through damaged tips which caused the injuries to patients," according to the FDA. Arcing happens when electrical currents are conducted to the patient’s body during the operation.
It is reported that Intuitive had issued an urgent medical device notification to alert health facilities that it had identified a problem with the Monopolar curved scissors have the potential to cause internal burns. The robot maker has tried to correct the problem by introducing new tip covers and has recommended that hospitals begin using the new covers immediately.
Some patients who have gone through procedures using the da Vinci equipment have reported experiencing various complications. One particular patient suffered bleeding into her pelvis from an injury to a major artery in the course of a robot-assisted hysterectomy. The patient died 13 days after the surgery.
Although Intuitive has tried to control the problem by replacing the tip covers, the FDA robotic surgery warning regarding the device still exists. This is because the company’s new tip cover does not seem to be completely effective in stopping the electrical sparks which have the potential to burn tissue.
If you are one of the patients injured by the da Vinci machine or know someone who has developed complications from this procedure contact the law firm, Gurfein Douglas, the lawyers with an edge.