Intuitive Surgical has just been hit with a Form 483 deficiency letter from the FDA following an inspection of its records relating to the use of its da Vinci robot. This type of form is a warning to the maker of a device or drug that it is not following FDA rules and is creating a risk of harm thereby. A major part of the deficiencies which were found was the failure to inform the FDA of steps Intuitive was taking privately to inform buyers of its machine that there were risks with arcing and burns. (5/30/13 letter)
The most serious of the non disclosures which the FDA found directly relate to the basis that our firm uses in the claims against Intuitive: electricity arcing from the monopolar scissors on to nearby tissue, burning it. Intuitive had been made aware of a specific risk of arcing but had not shared the information with the FDA. This involved surgeons "cleaning" the robotic instruments during the course of the surgery by rubbing one against another. This scraping had led to tears on the protective tip covers, allowing arcing to occur.
The FDA inspector also found that the company had not kept its manuals for operation of the da Vinci up to date, based upon information which it had in its records. It also had not reported certain instances of injuries which had occurred with the use of its machines, namely for thyroid surgery. Obviously the more public this information, the less the risk of injury. Keeping damaging information hidden from public view is just one of many liability areas our firm's robotic surgery team is pursuing on behalf of our clients. Our senior partner, Paul D. Rheingold, is available to answer your questions about robotic surgery claims, no matter what state you live in.