da Vinci May 8, 2013 Recall Notification and Surgical Usage Precautions
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
As we have discussed in many of our da Vinci robotic surgery litigation blogs and articles, we knew that that the robot's monopolar design and failed insulation lead to tragic injuries and deaths. Our firm was the first to file lawsuits in New York, with strong allegations that Intuitive Surgical had poor training procedures. Our New York litigation has since expanded nationwide.
On May 8, 2013, Intuitive Surgical made an "Urgent Medical Device Notification" relating to the hot shears (also called monopolar curved scissors) on the da Vinci robot due to the risk of stray electricity leaking to organs and tissue, causing thermal burns. Such burns may go undetected during surgery and manifest themselves only later when reoperation is needed and permanent damage or death may have occurred.
The recall notice also contains new surgical protocols for doctors which Intuitive Surgical has been concealed from doctors up to now. These points are:
- Don't do "air firing" by allowing a gap between the scissors and the tissue. This allows the current to arc to other tissue.
- Watch out for burns below or behind the operative field the surgeon can see (by inspecting after doing the surgery).
- Be careful using in patients who are more susceptible to electrical burn, such as ones who have had radiotherapy.
- Do not exceed a certain maximum in energy setting on the monopolar hot shears, as this will lead to thermal burns.