da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN A PUBLISHED CITRON RESEARCH ARTICLE TITLED INTUITIVE SURGICAL: ANGEL WITH BROKEN WINGS, OR THE DEVIL IN DISGUISE? ON JANUARY 17, 2013, IT WAS STATED IN AN EMBEDDED LINK ON PAGE 22 THAT IN DECEMBER 2003 THE WIDOW OF A (B)(6) TEACHER FILED A LAWSUIT AFTER A DOCTOR AT [HOSPITAL] ACCIDENTLY CUT HIS AORTA AND THE VENA CAVA WHILE USING THE DA VINCI SURGICAL ROBOT TO REMOVE A CANCEROUS KIDNEY. THE LAWSUIT ALLEGED THAT THE HOSPITAL ALLOWED DOCTORS INEXPERIENCED WITH THE ROBOT TO PERFORM THE SURGERY. THE CLAIM FURTHER CHARGED THAT THE HOSPITAL WAS MORE INTERESTED IN USING ITS NEW DEVICE THAN IN ENSURING HER HUSBAND'S SAFETY. ACCORDING TO THE LEGAL FINDINGS IN THIS CASE, THE COMPLAINT WAS FILED ON (B)(6) 2003 AND THE ONLY NAMED DEFENDANT WAS THE HOSPITAL. THE ALLEGATIONS STEM FROM THE CLAIM THAT THE DECEDENT UNDERWENT A TOTAL NEPHRECTOMY PROCEDURE. THE COMPLAINT ALSO ALLEGED THAT ISI HAD ESTIMATED 18 ROBOTIC SURGERIES WERE NECESSARY TO BE PROFICIENT WITH THE SYSTEM AND THAT ISI CERTIFIED THE DOCTOR AFTER ONLY THREE TRAINING SESSIONS. THE COMPLAINT STATED THAT THE DECEDENT SUFFERED FROM A SEVERED AORTA AND VENA CAVA. IN ADDITION, IT WAS ALLEGED THAT A LAP PAD WAS LEFT INSIDE OF THE DECEDEN

On August 18, 2002, Employee #1, a process technician, was setting up a mold change in a plastic injection molding machine. The product required two strokes of the platen. The first stroke would make the part, after which the robot arm would pick up and move the part to a different place on the mold face, whereupon the second stroke would complete the product. Employee #1 was in the danger zone between the mold halves while dialing in the final placement of the robotic arm. When he completed the set-up, he followed normal procedure and sent the robot arm out of the mold to the home position. The machine sensed that the robotic arm had cleared the mold area, and it cycled, crushing and killing Employee #1. The machine had been inadvertently left in auto mode during this final touch-up procedure, and the safety controls had been bypassed.

On May 7, 2002, Employee #1 was working in the refrigerator assembly line area when a piece of shipping cardboard became jammed in the transfer robot. He entered the caged area near the conveyor to clear the jam. At the same time, a coworker at the controls put the machine in manual mode and tried to release the robot arms. When the coworker did this, Employee #1's left leg became pinned between the pusher and the conveyor, and it remained caught for several minutes before coworkers were able to free him. Employee #1 suffered severe bruising to his leg but did not require hospitalization.

On January 15, 2002, Employee #1, a maintenance technician for Xilinx Corporation, was performing normal maintenance on a Seiko Epson Handler scanner. He removed a side door to improve access and finished with the adjustments. While test running the machine from in front and watching the operation, he inadvertently reached up and rested his hand on the frame of the unit. His fingers slipped into the opening, and the robot carriage head moved toward the front. The outside edge of the head became caught and pinned his right index finger between itself and the frame, amputating the finger between the first and second knuckle. The hazard was not recognizable.