MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC.DA VINCI SI SURGICAL SYSTEMENDOSCOPIC INSTRUMENT CONTROL SYSTEM

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC.DA VINCI SI SURGICAL SYSTEMENDOSCOPIC INSTRUMENT CONTROL SYSTEM: it was reported that during a da vinci si adrenalectomy, distal pancreatectomy, and splenectomy procedure performed on (b)(6) 2009, the surgeon allegedly injured the patient's aorta. The legal complaint indicated that the injury occurred during dissection and the surgeon made the decision to convert the robotic surgery to open surgical techniques. The legal complaint alleged that during transition, the robot's arm was inappropriately moved, causing a tear in the patient's aorta. The surgeon reportedly repaired the aorta. The legal complaint indicated that post-operatively, the patient experienced renal failure and the family withdrew life support shortly after surgery. No further clinical information was provided.