da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2007. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2007. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2007. THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED A PUNCTURED BLADDER AND INCONTINENCE. THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO OTHER INFORMATION WAS PROVIDED. INFORMATION RELATED TO THE DA VINCI SYSTEM WAS NOT PROVIDED; THEREFORE, THE MODEL AND SERIAL ARE NOT KNOWN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY, BSO WITH LYSIS OF ADHESIONS AND REPAIR OF A SMALL UMBILICAL HERNIA ON (B)(6) 2007. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT (OP) AND THE SUBSEQUENT IMAGING AND STENT PLACEMENT REPORTS, AND THE OP FOR THE PATIENT'S URETERAL REIMPLANTATION. NO MEDICAL HISTORY REGARDING THE PATIENT WAS PROVIDED TO ISI. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. AFTER EXTENSIVE LYSIS OF OMENTAL ADHESIONS TO AN UMBILICAL HERNIA, THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL CAUTERY AND DIVISION OF THE INFUNDIBULOPELVIC, ROUND, AND BROAD LIGAMENTS. THE UTERINE ARTERIES AND THE CARDINAL LIGAMENTS WERE CAUTERIZED AND DIVIDED. THE COLPOTOMY WAS PERFORMED AGAINST A V-CARE COLPOTOMY CUP, THE UTERINE STRUCTURES REMOVED THROUGH THE VAGINA. THE VAGINAL CUFF WAS SUTURED CLOSED, THE EXISTING FACIAL DEFECT IN THE ANTERIOR ABDOMINAL WALL CLOSED, AND THE SURGERY COMPLETED WITHOUT COMPLICATIONS. IT WAS NOTED THAT THE FOLEY WAS DRAINING BLUE URINE FROM IV INDIGO CARMINIE INDICATING GOOD URI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL RETROPUBIC PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS ((B)(6) 2007). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL: (B)(6) 2007, INFECTIOUS DISEASE CONSULTATION (B)(6) 2007, GENERAL SURGERY CONSULT (B)(6) 2007, PULMONOLOGY CONSULT (B)(6) 2007, HEMATOLOGY CONSULT (B)(6) 2007, NEUROLOGY CONSULT (B)(6) 2007, NEPHROLOGY CONSULT (B)(6) 2007, DISCHARGE SUMMARY (B)(6) 2007 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. UPON ENTERING INTO THE ABDOMEN AND CREATING A PNEUMOPERITONEUM NO SIGNIFICANT ADHESIONS WERE NOTED. SUBSEQUENTLY, A ROUTINE RADICAL PROSTATECTOMY WAS PERFORMED WITHOUT INCREASED DIFFICULTY OR NOTED INJURIES TO ADJACENT STRUCTURES. THE WOUND AREA LOOKED TO HAVE NO APPARENT INJURY TO THE BLADDER OR BOWEL. ON (B)(6) 2007 - THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EXTENSIVE ADHESIOLYSIS, SMALL BOWEL RESECTION AND REPAIR OF MULTIPLE ENTE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON JUNE 10, 2008, INTUITIVE SURGICAL WAS NOTIFIED OF A PT DEATH PER LITIGATION DOCUMENTATION WHICH REPORTS THE FOLLOWING: IN 2007, FIVE DAYS AFTER UNDERGOING A DA VINCI RADICAL PROSTATECTOMY PROCEDURE, A PT UNDERWENT EMERGENCY EXPLORATORY LAPAROTOMY AND INTER ALIA. BOWEL NECROSIS WITH SEPTICEMIA WAS OBSERVED AND SAID TO BE THE RESULT OF AN INTEROPERATIVE MESENTERY TEAR. SIX CENTIMETERS OF CONTINUOUS STITCH WAS APPLIED TO REPAIR THE AFFECTED AREA, HOWEVER, THE PT EXPIRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER HAVING DA VINCI ROBOTIC SURGERY FOR PROSTATE REMOVAL, I REMAINED IN THE HOSPITAL FOR 33 DAYS AND WAS GIVEN 18 PINTS OF BLOOD. I ALMOST DIED TWICE BECAUSE OF INTERNAL BLEEDING AND OTHER COMPLICATIONS. THE SURGEON DID NOT EVEN COME TO SEE ME AFTER THE SURGERY. I SPOKE WITH AN INTERN THAT HELPED THE SURGEON WITH THE OPERATION AND HE TOLD ME THAT AT TIMES SOME OF THE ARMS FAILED TO DO WHAT IT SUPPOSED TO DO. ALSO, THE INTERN SAID THAT HE FELT THAT THE SURGEON DID NOT HAVE SUFFICIENT TRAINING TO PERFORM THE OPERATION. I HAD TO HAVE SEVEN MORE OPERATIONS TO CORRECT THE DAMAGE TO MY INTERNAL ORGANS BECAUSE OF THE DEFECTIVE DA VINCI ROBOT. IF A SURGEON DOES NOT HAVE THE TRAINING AND IF THE MFR (INTUITIVE SURGICAL SUPPLY) IS ALLOWED TO MANUFACTURE DEFECTIVE SURGICAL DEVICES SUCH AS THE DA VINCI ROBOT THEN THEY WILL END UP LIKE I DID AND THAT MEANS SLOWLY BLEEDING TO DEATH AND HAVING TO HAVE MORE EXTENSIVE SURGERIES TO REPAIR THE DAMAGES THAT WERE CAUSED TO ME BY THE USE OF THE DA VINCI ROBOT AND THE SURGEON.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6). RE: DA VINCI ROBOT IS A VERY DANGEROUS OPERATION DEVICE! DEAR SIR: I AM WRITING A LETTER TO YOU EXPLAINING JUST WHAT HAPPENED TO ME WHEN I WAS OPERATED ON VIA DA VINCI ROBOT. FIRST OF ALL, MY UROLOGIST/SURGEON (MR. (B)(4)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED BECAUSE ON THE GLEANSON SCALE READING OF 6. DR. (B)(6) SAID THAT HE RECOMMENDED USING THE DA VINCI ROBOT BECAUSE IT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE EVERYTHING ON A BIG SCREEN SO THAT HE WOULD BE ABLE NOT TO CUT ANY NERVES OR BLOOD VESSELS THAT WOULD AFFECT ME FROM HAVING SEX AND THAT IT WOULD PREVENT ME FROM HAVING INCONTINENCE. DR. (B)(6) CONVINCED ME AND MY FAMILY THAT THE DA VINCI ROBOT WAS THE WAY TO GO AND THAT MY FAMILY COULD PICK ME UP AT THE HOSPITAL THE NEXT MORNING. WHEN MY FAMILY CAME TO GET ME, I WAS IN A BAD WAY. I COULD NOT STAND, EAT, MOVE AND I WAS IN SO MUCH PAIN. THE NURSES HAD PUT ON ME A DRAINAGE BAG AND ABOUT EVERY TWO HOURS THE BAG WOULD FILL UP WITH BRIGHT RED BLOOD JUST LIKE IF I HAD JUST CUT MYSELF. DRAINAGE WOULD NOT BE THE SAME COLOR AS PURE BLOOD. DR. (B)(6) TOLD MY FAMILY THAT I WOULD NOT BE GOI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PERFORATED TERMINAL ILEUM WITH INTRA-ABDOMINAL FREE AIR, PERITONITIS FOLLOWING A MYOMECTOMY PERFORMED ROBOTICALLY (LAPAROSCOPICALLY).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2007. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED SEVERAL WEEKS AFTER A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE, THE PT EXPIRED. NO ADDITIONAL INFO WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI RADICAL PROSTATECTOMY ON (B)(6) 2006 FOR ADENOCARCINOMA OF THE PROSTATE. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES PARTIAL RECORDS FROM MULTIPLE SUBSEQUENT HOSPITALIZATIONS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PRIMARY SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . ON (B)(6) 2006, THE PATIENT PRESENTED WITH OF URINARY LEAKAGE THROUGH THE RECTUM AND WAS DIAGNOSED WITH A COLOVESICAL FISTULA. MULTIPLE STUDIES AND MANEUVERS WERE USE TO ATTEMPT TO TREAT THIS FISTULA CONDITION. THE PATIENT HAD TO HAVE PERSISTANT DRAINAGE THROUGH A FOLEY CATHETER. THERE WAS STOOL LEAKING INTO HIS FOLEY CATHETER BAG. HE HAD BOUTS OF INFECTION. THE PATIENT DEVELOPED A DVT AS A COMPLICATION OF HIS CONDITION AND REQUIRED COUMADIN. HE HAS PERSISTANT LOWER EXTREMITY EDEMA. ON (B)(6) 2008, THE PATIENT UNDERWENT DIVERSION OF STOOL THROUGH AN ILEOSTOMY, PERINEAL REPAIR OF RECTOURETHRAL FISTULA WITH GRACILIS MUSCLE FLAP TO ALLOW COLO-VESICAL FISTULA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY FOR PROSTATE ADENOCARCINOMA ON (B)(6) 2006. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP MEDICAL AND CONSULTATION REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY .THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . ON (B)(6) 2006 THE PATIENT PRESENTED WITH SYMPTOMS OF PERIANAL SWELLING AND WAS FOUND TO HAVE A PERIRECTAL ABSCESS THAT WAS DRAINED IN THE PHYSICIANS OFFICE. ON (B)(6) 2007 THE PATIENT WAS FOUND TO HAVE A SMALL FISTULA-IN-ANO THAT WAS REMOVED IN OUTPATIENT SURGERY. ON (B)(6) 2007 THE PATIENT HAD A BILATERAL INGUINAL HERNIA REPAIRS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10/01/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056296 WITH THE FOLLOWING EVENT DESCRIPTION: THIS IS A LATE REPORT AS WE WERE UNAWARE WE COULD HAVE REPORTED EARLIER TO FDA. MY MOTHER, (B)(6), AT TIME OF DEATH, WAS UNDERGOING A MITRAL VALUE [SIC] REPAIR WITH THE SURGEON, DR. (B)(6), USING THE DAVINCI ROBOT. THIS OCCURRED AT (B)(6) ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, THE ROBOT NICKED HER HEART WHICH RESULTED IN BLEEDING OUT AND EMERGENCY OPEN HEART SURGERY. SHE NEVER RECOVERED AND DEVELOPED SEPSIS INFECTION 4 DAYS LATER. WE WERE INFORMED LATER THAT OUR MOM WAS THE ONLY THE 3RD PATIENT FOR HEART VALVE SURGERY ON THIS ROBOT. WE ALSO ARE AWARE THAT ANOTHER WOMAN DIED SUBSEQUENTLY BY THE SAME ROBOT AND PHYSICIAN. THE DOCTOR LEFT TOWN AFTER THIS. (WE NEVER FILED A LAWSUIT DUE TO (B)(6) LAWS ON DAMAGES.) I AM WRITING THIS TO INFORM THE FDA AND TO NOTIFY YOU OF AN ADVERSE EVENT FOR YOUR STATS OF THIS DAVINCI ROBOT. MY HOPE IS THAT NO ONE WILL HAVE TO DIE FROM THIS ROBOT IN THE FUTURE IN THE CARDIAC REALM OF USE FOR DAVINCI. THANK YOU. (B)(6). ON 10/02/2015, ISI CONTACTED THE INITIAL REPORTER (THE PATIENT'S DAUGHTER) AND OBTAINED THE FOLLOWING INFORMATI

On July 24, 2006, Employee #1 was operating at a robotic work station. He was killed when he was crushed between a robotic arm and frame of one of the robot's work stations, referred to as the "degator." Employee #1 was found with his head pinned between the robotic arm and the degator. His arm appeared to be either reaching to remove scrap that had been dropped by the robot, or reaching to activate a "reset" button on the control panel. There was no memory in the robot computer, and testing of the robot showed no malfunction in robot movement. This robotic process produced medium caliber ammunition, and the points of operation are enclosed escept for the area where Employee #1 was killed.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6), 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6)2006, AND ALLEGED TO HAVE SUSTAINED A PERFORATED BOWEL INJURY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2006. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES. THE PATIENT WAS MADE AWARE THAT HIS INJURIES MAY BE THE RESULT OF THE DA VINCI ON (B)(6) 2013.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI DIAGNOSTIC LAPAROSCOPY AND CHOLECYSTECTOMY PROCEDURE FOLLOWED BY A PLANNED OPEN PANCREATICODUODENECTOMY SURGICAL PROCEDURE ON (B)(6) 2006. THE PATIENT REPORTEDLY EXPIRED ON AN UNSPECIFIED DATE. ISI WAS PROVIDED WITH THE (B)(6) 2006 OPERATIVE REPORT AS WELL AS HER SUBSEQUENT OPERATIVE SUMMARIES AND HER HOSPITAL DISCHARGE SUMMARY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER CARE ON (B)(6) 2006 AND THEN WAS DISCHARGED ON (B)(6) 2006. NO FURTHER MEDICAL RECORDS WERE PROVIDED AFTER THIS DISCHARGE DATE. THE OPERATIVE REPORT DATED (B)(6) 2006 INDICATED THAT THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPY AND CHOLECYSTECTOMY, OPEN PANCREATICODUODENECTOMY, PORTAL VEIN RESECTION AND RECONSTRUCTION. THE PREOPERATIVE DIAGNOSIS WAS NOTED AS PANCREATIC HEAD MASS AND CYSTIC NEOPLASM AND THE POSTOPERATIVE DIAGNOSIS WAS PANCREATIC CARCINOMA. THE SURGICAL PROCEDURE BEGAN WITH A ROBOTIC ASSISTED DIAGNOSTIC LAPAROSCOPY TO IDENTIFY THE BODY AND NECK OF THE PANCREAS. THE PROCEDURE THEN PROCEEDED WITH A CHOLECYSTECTOMY. ONCE T

On March 22, 2006, Employee #1 was operating a left-hand Sill Welder. A robot, used by the company, caught her on the back of her neck, pinning her head between it and the part that was being welded. Employee #1 was transported to Northcrest Medical Center, where she was pronounced dead.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2005. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED URINARY INCONTINENCE AND ERECTILE DYSFUNCTION. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2005. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES. REPORTEDLY, THE PATIENT EXPIRED IN (B)(6) 2010. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A PROCEDURE TO REPAIR THE MITRAL VALVE REGURGITATION INVOLVING USE OF THE DA VINCI ROBOTIC SURGICAL SYSTEM, THE AORTIC VALVE LEAFLET WAS PERFORATED DURING PLACEMENT OF THE CARDIOPLEGIA CATHETER. THIS NECESSITATED INITIATION OF CARDIOPULMONARY BYPASS TO REPAIR THE LEAFLET AND COMPLETE THE PROCEDURE. UPON REMOVAL FROM BYPASS, THE PATIENT ENTERED CARDIOGENIC SHOCK DUE TO BIVENTRICULAR FAILURE. ADDITIONALLY THE PATIENT WENT INTO RENAL FAILURE. THE PATIENT REMAINS HOSPITALIZED WITH PARTIAL RECOVERY OF LEFT VENTRICULAR FUNCTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10/30/2015, ISI RECEIVED FDA VOLUNTARY REPORT MW5044826 WITH THE FOLLOWING EVENT DESCRIPTION: HAD A DA VINCI ASSISTED PROSTATECTOMY IN (B)(6) 2005 (CAN'T RECALL EXACT DATE) AT (B)(6) HOSPITAL; (B)(6). ONE OF MY URETERS WAS KINKED HAD TO WHERE [SIC] A STENT FOR SIX WEEKS. WAS CHARACTERIZED AS A SLIGHT COMPLICATION. WAS IT REPORTED? (B)(6); SSA (B)(4). ON 11/05/2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE PATIENT DIRECTLY. ALTHOUGH THE EVENT DATE NOTED ON THE FDA VOLUNTARY REPORT IS (B)(6) 2005, THE PATIENT COULD NOT VERIFY THE ACTUAL DATE AS TO WHEN HE UNDERWENT THE DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE IN 2005. THE PATIENT STATED, IT WAS AROUND THAT TIME. ACCORDING TO THE PATIENT, THE SITE DID NOT PROVIDE HIM WITH A POSSIBLE CAUSE OF THE OPERATIVE COMPLICATION. PER THE PATIENT, THERE WAS NO ALLEGATION FROM THE SITE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON 11/20/2015, ISI CONTACTED THE SITE'S LEGAL AFFAIRS DEPARTMENT. HOWEVER, THE SITE'S LEGAL AFFAIRS DEPARTMENT WAS UNWILLING TO PROVIDE ANY INFORMATION REGARDING THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A PROCEDURE EMPLOYING THE USE OF THE DA VINCI ROBOTIC SURGICAL SYSTEM TO TREAT ATRIAL FIBRILLATION VIA RF ABLATION OF ECTOPIC FOCI, INTRAOPERATIVE BLEEDING WAS EXPERIENCED, THAT REQUIRED INITIATION OF CARDIOPULMONARY BYPASS. THE BLEEDING OF THE ATRIAL WALL WAS CAUSED BY THE ATRICURE ABLATION ELECTRODE (ISOLATOR TRANSPOLAR PEN), WHICH HAD BEEN UNHOOKED FROM THE ROBOTIC ARM AND WAS BEING MANIPULATED MANUALLY. CARDIOPULMONARY BYPASS WAS INITIATED TO RECTIFY AND COMPLETE THE PROCEDURE. SECONDARY COMPLICATIONS INCLUDED A STROKE AND AORTIC DISSECTION. THE PATIENT HAS BEEN DISCHARGED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2004 AND DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS BLEEDING DUE TO POOR FUNCTION OF THE STAPLER.(NON ISI DEVICE) . IT WAS ALSO NOTED THAT THE PATIENT HAD A BLADDER LACERATION WHICH APPEARED TO BE DUE TO THE DA VINCI ROBOT FAILURE. ACCORDING TO THE OPERATIVE REPORT THE FOLLOWING WAS NOTED:THERE WAS EXTENSIVE SCARRING ON THE RIGHT SIDE BETWEEN THE NEUROVASCULAR BUNDLE AND THE RIGHT PROSTATE. ON THE LEFT SIDE, THERE WAS LESS SCARRING; HOWEVER, THERE WAS STILL ADHESION BETWEEN THE PERIPROSTATIC TISSUES AND THE PROSTATE. DURING THE PROCEDURE, THE DAVINCI ROBOT FAILED AND THE PROCEDURE HAD TO BE COMPLETED WITH CONVENTIONAL LAPAROSCOPY. THE VESICOURETHRAL ANASTOMOSIS WAS PERFORMED; HOWEVER, THERE WAS SOME LEAKING FROM THE POSTERIOR ASPECT AT THE END OF THE OPERATION. THE ENDOSCOPIC STAPLING DEVICE WAS BROUGHT IN AND THIS WAS USED TO DIVIDE THE DORSAL VENOUS COMPLEX. THERE WAS SEEN TO BE SOME BLEEDING, HOWEVER, WITH WHAT APPEARED TO BE POOR FUNCTION OF THE STAPLER. THE DORSAL VENOUS COMPLEX WAS THEN OVERSEWN CONTROLLING THE BLE

On November 16, 2004, Employee #1 was assisting an electrical engineer in troubleshooting a malfunctioning robot. He was crushed between the lifting arm and the lower frame of the robot when the lifting arm dropped. Employee #1 fractured his chest and was hospitalized.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MINIMALLY INVASIVE SURGICAL PROCEDURE, A SMALL TEAR OCCURRED IN THE ANTERIOR PORTION OF THE SUPERIOR VENA CAVA (SVC) WHEN DISSECTING THE SVC PERICARDIAL REFLECTION. IT APPEARED THAT A PORTION OF THE SVC WAS PINCHED BETWEEN THE INSTRUMENT JAWS WHEN THE SURGEON WAS ATTEMPTING TO BLUNT DISSECT THROUGH THE PERICARDIAL REFLECTION. A SMALL RIGHT THORACOTOMY WAS MADE TO CONTROL THE BLEEDING FROM THE SVC. NO SYSTEM OR INSTRUMENT MALFUNCTION WERE REPORTED. IT WAS REPORTED THAT THE PT RECOVERED AND WAS RELEASED FROM THE HOSP.

On March 30, 2004, an employee was working for Gentrag Corporation that manufactured motor vehicle transmission and power train parts. Some of the tasks at this work site were automated and were handled by industrial robots. An industrial robot moved assembled product from a conveyer to one of two machines for testing. The robot then unloaded the product and placed the product onto another conveyer for movement to the next processing step. The robot and the two testing machines were separated from employees and the rest of the plant by solid walls on three sides and a chain link fence on one side creating a robot work cell. Interlocked gates were present in the fence and one wall. On March 30, 2004, the employee entered the barricaded work cell while the system was in operation. The employee was caught by the head or neck between the fixture on the end of the robotic arm and the testing machine and was killed. The gates into the work cell were found to be closed following the accident. The employee may have gained entry by climbing over the fence or crawling through openings in the fence where product was moved by conveyer out of the work cell.

CyberKnife — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, AN ACCURAY EMPLOYEE LEARNED OF THE DEATHS OF TWO PTS DETAILED IN A RESEARCH PAPER (DISEASES OF THE ESOPHAGUS 2012, V:25, PG 623-629, TITLE: ESOPHAGEAL TOLERANCE TO HIGH-DOSE STEREOTACTIC ABLATIVE RADIOTHERAPY). ONE PT RECEIVED TREATMENTS FOR A LUNG TUMOR IN PARALLEL WITH CHEMOTHERAPY. SIX MONTHS AFTER TREATMENT, THE PT DEVELOPED FATAL HEMOPTYSIS (COUGHING UP OF BLOOD). THE SECOND PT RECEIVED TREATMENTS FOR A SPINAL TUMOR PARALLEL WITH CHEMOTHERAPY. FOUR MONTHS POST TREATMENT, THE PT DEVELOPED AN ESOPHAGEAL PERFORATION AND INFECTION LEADING TO DEATH. THE DOCTOR CONFIRMED THE PTS HAD BEEN TREATED CORRECTLY AND THE SYSTEM HAD NOT MALFUNCTIONED.

At around 11:55 p.m. on July 28, 2003, Employee #1, a maintenance worker with Lifetime Products, was found crushed under a pneumatic lift table which was under approximately 3500 PSI hydraulic pressure. The accident occurred in the robot cage, which is surrounded by a chain-link fence and a gate which was interlocked to shut down the robot while it was open. The robot was not running when the compliance officer arrived. In addition to the robot, the cage is surrounded a pneumatic lift table which is used to raise or lower stacks of products coming off the assembly line. The products, which were in cardboard boxes, were placed on the lift table by the robot. Once on the lift table, the products would be raised or lowered the correct location for a cardboard sleeve to be stapled to them. Evidence indicated that Employee #1 was working on the staplers. A box of staples and a set of Allen wrenches were located next to the lift table and staplers. One of the Allen wrenches was removed from the set and was laying on the floor next to where Employee #1 was found. This Allen wrench fit the adjustment screws on the staplers. A coworker stated that he heard the staple guns firing ten-round bursts within a few minutes of when the accident occurred, indicating that someone was working on the staplers. It was not determined during the inspection how the lift table was activated while Employee #1 was underneath it, but it apparently trapped him while he was attempting to exit the pit underneath the table. The medical examiners report indicates that Employee #1 died as a result of compressional asphyxia. A subsequent investigation was conducted by Lifetime Products. This investigation, dated August 4, 2003, indicated that the lift table may have been activated by the stapler linear sl

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SYSTEM FAILURE DURING A DA VINCI SURGICAL PROCEDURE. SURGEON WAS UNABLE TO RESTART THE SYSTEM. SYSTEM ERROR MESSAGE FUNCTIONED APPROPRIATELY. THE CASE WAS CONVERTED AND COMPLETED. NO OTHER PATIENT INJURY OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) FOR FIBROID UTERUS ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL ON (B)(6) 2013. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION (INCIDENTAL CYSTOTOMY). AFTER INSERTION OF THE V-CARE UTERINE MANIPULATOR AND CREATION OF A PNEUMOPERITONEUM WITH THE VERESS NEEDLE , 4 ADDITIONAL PORTS WERE INSERTED AND THE ROBOT DOCKED. INSPECTION OF THE PELVIS REVEALED SEVERE OMENTAL AND SMALL BOWEL ADHESIONS. EXTENSIVE ADHESIOLYSIS WAS PERFORMED ANTERIORLY BY THE BLADDER AS WELL AS SEPARATING THE SMALL BOWEL FROM THE POSTERIOR FUNDUS UTERI. LATERAL LIGAMENTS WERE CAUTERIZED AND CUT BILATERALLY DOWNWARDS. THE BLADDER FLAP WAS CREATED USING SHARP AND BLUNT DISSECTION. THEN A POSTERIOR COLPOTOMY WAS PERFORMED FOLLOWED BY A CIRCUMFERENTIAL INCISION AFTER CAUTERIZATION. THE SPECIMEN WAS THEN REMOVED THROUGH THE VAGINA. AT THIS TI

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DA VINCI SURGICAL SYSTEM IS CURRENTLY BEING USED FOR MOBILIZATION OF THE INTERNAL MAMMARY ARTERY (IMA) DURING CORONARY ARTERY BYPASS PROCEDURES UNDER FDA CLEARANCE K002489 (ISSUED 2001), AND FOR TOTALLY ENDOSCOPIC CORONARY ARTERY BYPASS PROCEDURES UNDER THE AUSPICES OF IDE # G010011. BASED ON THE INFO PROVIDED, THE EVENT DOES NOT MATCH ANY COMPLAINT RECORDED FOR THE DA VINCI SURGICAL SYSTEM OR ITS INSTRUMENTS, NOR DOES IT MATCH ANY PROCEDURE PERFORMED UNDER THE IDE. THE MEDWATCH REPORT INDICATES THAT THE USER FACILITY WAS NOTIFIED AND INTUITIVE SURGICAL HAS NOT BEEN CONTACTED BY THE FACILITY, LEADING TOTHE CONCLUSION THAT A RELATIONSHIP BETWEEN THE PT CONDITION AND THE DA VINCI SYSTEM USED DURING THE PROCEDURE COULD NOT BE ESTABLISHED BY THE HOSPITAL. COMPANY'S CONCLUSION IS THAT THIS IS NOT AN MDR REPORTABLE EVENT BASED ON THE FOLLOWING: NO DEATH OR SERIOUS INJURY ATTRIBUTED TO THE DEVICE OCCURRED. NO MALFUNCTION OF THE DEVICE WAS REPORTED TO HAVE OCCURRED.

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.

On December 29, 2001, Employee #1 was cleaning up at the end of his shift and entered a robot cell that was not locked out. When the robot machinery started up, it grabbed his neck and pinned Employee #1 under a wheel rim, asphyxiating him.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A PATIENT STORY POSTED ON THE INTERNET CONCERNING THEIR DA VINCI HYSTERECTOMY SURGICAL PROCEDURE: THE PATIENT INDICATED THAT ON (B)(6) 2000 SHE UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE AT (B)(6) HOSPITAL (LOCATION UNKNOWN) AND DURING THE SURGICAL PROCEDURE HER BLADDER WAS NICKED. THE PATIENT INDICATED THAT PRIOR TO THE SURGICAL PROCEDURE; SHE WAS ADVISED TO UNDERGO A HYSTERECTOMY WITH CYSTOCELE AND RECTOCELE REPAIR. THE PATIENT INDICATED THAT HER DOCTOR ADVISED HER THAT HER BLADDER DURING THE SURGICAL PROCEDURE WAS NOT ADDRESSED BECAUSE IT HAD DESCENDED TO A LEVEL 3, HER CERVIX WAS NOT REMOVED AND THE RECTOCELE WAS REPAIRED. THE PATIENT INDICATED THAT 2 DAYS POST OP SHE WAS RELEASED FROM THE HOSPITAL AND THAT SHE DID NOT RECOVER FROM THE SURGICAL PROCEDURE. THE PATIENT INDICATED FOR 7 DAYS AFTER THE DA VINCI SURGICAL PROCEDURE, HER BLADDER WOULD HARDEN AND SHE FELT AS THOUGH SHE WAS EXPERIENCING END STAGE LABOR AND HAD TO SEEK A SPECIALIST FOR HER BLADDER. THE PATIENT INDICATED THAT EXAMINATION BY THE SPECIALIST FOUND THAT HER BLADDER EXHIBITED EXTENSIVE SCARRING, MUSCLE DAMAGE AND THERE WAS NO EVIDENCE OF RECTOCELE REPAIR. THE PATIENT

Employee #1, a maintenance worker, was called to a robotic cell because a pin was sticking. Instead of following proper procedures and opening the gate, which would have shut down the unit, for some reason he climbed over the 6 ft high fence and tried to repair the unit while the robot was operating. Employee #1 became caught in the machine and was killed. He had received about five or six weeks of training and had worked on robots since March of 1999. Entering the cell in this manner was forbidden by company regulations.

Employee #1, a default chaser at the boxed meat storage facility of a meatpacking plant, was observing a coworker do maintenance on the Lovejoy coupler of an outbound conveyor. This meat storage and distribution system was largely automated and computer controlled. A series of conveyors moved the boxed meat to carousels for storage. Robots picked the boxes off the inbound conveyors and placed them on carousels. They also took the boxes out of storage to be shipped as needed. As the coworker performed his duties, Employee #1 asked him what he was doing. The coworker looked up and then heard the robot activate as Employee #1 stepped up on the end of the inbound conveyor. The robot came down to the level of the inbound conveyor and caught Employee #1 against it. He was struck on the back of the head and became trapped with his body in a position folded forward. Coworkers tried unsuccessfully to manually remove the robot, and eventually were able to move it using the main controls. Once released, Employee #1 fell approximately 15 ft to the floor. He died of severe blunt force trauma to the back of his head, and was most likely dead before he fell.

Employee #1 was crushed when he became trapped between the lift arm clamp brackets of a palletizer robot. He died of mechanical asphyxia.

Employee #1 was operating a Robot Coupe CL-50 vegetable slicing machine when his right little finger struck against the blade and was amputated. The blade cover guard was either broken or missing.

An employee was using a temporary electric cord to power a robotic control unit for a test. The cord, which had been temporarily connected to the robot unit with stripped conductors on one end, was plugged into a 480-volt receptacle. The exposed conductor ends were dangling in front of the robot box. The employee contacted the exposed conductors and the box and was electrocuted.

On December 12, 1997, Employee #1 was using a Raymond dual-drive, stand-up, counterbalanced forklift to transport pallets from one compartment into another. After dropping off a pallet, he was backing up the forklift when he encountered an automated guided vehicle (AGV) that was traveling in reverse to the same point. The AGV was operated by a guided system built into the concrete floor. Employee #1 was standing with his back to the AGV, looking over his left shoulder, and had to choose between hitting the AGV or striking a stairway that led to the mezzanine storage area. He steered the forklift to avoid hitting the AGV and struck the stairway l-beam, fracturing his lower left leg. Emergency Services responded and transported Employee #1 to Memorial Medical Center. Four days later, while undergoing surgery, he slipped into a coma. He was removed from life support, at his family's request, on December 30, 1997.

An employee was repairing equipment when he was struck by an automated material-handling robot. He died of his injuries.

An employee was operating a die-casting machine used to manufacture automotive parts. At the beginning of the first shift, each die pair has a Julian date screw installed with the current date on it. Operators from each of three shifts would punch a dot on the date screw to have the stamp indicate on which shift the parts were manufactured. One day, a backup die-casting machine operator was punching a dot for the second shift on the two pairs of dies on his machine. No one was watching him. While he was doing this, an alarm on the machine sounded. This alarm is designed to announce when there is a problem, such as the machine's jamming or operating out of sequence. Nearby machine operators heard the alarm and responded. When they approached the machine, they saw the backup die-casting machine operator in the die area. They found that his head was severely crushed. The machine was on. The robot arm had been stopped after it had removed the part and moved out of the way. The automatic sprayer had been turned off, but the machine was left on and in automatic. The machine had not been locked out. Investigation revealed that, with the robot arm off and out of the way and with the sprayer shut off, the machine will continue to cycle if not turned off. The employer had a lockout program that was inadequate. It did require employees to lock out the die-casting machines during repair or adjustments in the die area. However, employee interviews revealed that it was routine for the die punching operation to be performed without the machine being locked out. In addition, two supervisors admitted that they did not enforce the requirement to lock out the machines. In fact, they had worked in the die areas themselves without locking out the machine. The machine runs automatically, wit

Employee #1 was using a welding/drilling robot to assemble frames for basketball backboards. In this process, the material used to make the backboards is laid out on an A-frame turning table. One side drills the holes and the other side welds the material together; when the one side has been drilled, the table rotates 180 degrees for it to be welded. Employee #1 noticed that one of the holes had not been drilled completely and he reached between the A-frame to manually set that particular drill. When he pushed the MANUAL button, the robot thought that the cycle was complete and it began turning the table for the next sequence. The rotating table and A-frame pinned Employee #1 against the wall on the welding side. He suffered chest trauma, for which he was hospitalized.

Employee #1 and a coworker from AGA, a company that supplied gas to the Willard Foundry, were onsite to give an estimate on Willard's requested additions. They were being escorted by the head of maintenance. While the three of them were at the molten aliminum pouring area, the pouring operation, which was being executed by a robot, unexpectedly stopped. The escort left the two AGA employees to look for the problem. In about five minutes the escort found the problem in the shakeout area about 20 feet away. When he adjusted the switch, the pouring started again. Employee #1 and his coworker were on the pouring floor in the envelope of the robot ladle. Employee #1's chest was pinned against a mold by an approximately 150 lb ladle containing 1,400 degree Fahrenheit aluminum. He was killed.