Intuitive Surgical Recalls Robot Machines Due to Mechanical Problems
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
In November Intuitive Surgical issued a recall of the majority of its DaVinci robotic surgery machines in the US and worldwide due to a "friction" problem the machines were experiencing. The company itself labeled the recall as "urgent." Due to this "friction" problem, the arms of the machine would temporarily stall. This would no doubt induce confusion in the surgeon, since the machine would then have to "catch up"-that is, move faster than the doctor might anticipate. The recall was revealed by the FDA on its website in December.
This recall for a defect follows several others we have reviewed on our blog pages on our website. The most serious related to the scissors (hot shears) which were inadequately insulated. This had led to escape of electricity with documented instances of burns to various internal organs. We are continuing to investigate cases of patients injured by these robotic machines and then placing them into a tolling agreement with the defendant.