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 THAT DURING DA VINCI S RADICAL NEPHRECTOMY PROCEDURE PERFORMED IN 2009, THE SURGEON ACCIDENTLY LIGATED AND CUT THE PT'S SUPERIOR MESENTERIC ARTERY. THE PROCEDURE WAS CONVERTED TO A TRADITIONAL HAND ASSISTED OPEN PROCEDURE. THE PT EXPIRED POSTOPERATIVELY IN THE SAME DAY.

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 THAT IN 2009, AFTER A SUCCESSFUL DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE PATIENT EXPERIENCED DIFFICULTIES COMING OFF OF CARDIOPULMONARY BYPASS. THE PT'S HEART WAS SAID TO NOT BE CONTRACTING. TWO DAYS LATER, THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR "VENTRICULAR SYSTEM." THE PT WAS REMOVED FROM LIFE SUPPORT AFTER IT WAS DEEMED THAT IT WOULD NOT BE POSSIBLE TO PERFORM "VENTRICULAR SYSTEM." THE PT EXPIRED IN THE SAME DAY.

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 THAT POST A DA VINCI S LUNG BIOPSY SURGICAL PROCEDURE, THE PT EXPIRED. THE SITE STATED THAT THE PLANNED DA VINCI S PROCEDURE WAS SUCCESSFULLY COMPLETED, HOWEVER, THE PT WAS IN OVERALL POOR HEALTH.

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 PANCREATIC SURGICAL PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM ON (B)(6) 2009. REPORTEDLY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY DIED. 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ASSISTED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, BILATERAL PERIAORTIC LYMPHADENECTOMY, AND OMENTECTOMY ON (B)(6) 2009 FOR CLINICAL STAGE II UTERINE SEROUS CARCINOMA. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. PER THE OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS AWAKENED, EXTUBATED, AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 50 ML. ON (B)(6) 2009, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION AND ANASTOMOSIS. PER THE OPERATIVE REPORT, THE PATIENT HAD DEVELOPED RIGHT LOWER LOBE PNEUMONIA AFTER UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2009 AND WAS NOTED TO BE CLINICALLY SEPTIC WITH INCREASING ABDOMINAL DISTENSION AND DISCOMFORT SUSPICIOUS FOR AN UNDERLYING ABDO

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 THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT WAS VERY SICK AND THE CASE WAS DIFFICULT. THE PATIENT WAS ALSO LARGE AND THE PROSTATE WAS LOCATED DEEP INSIDE THE PATIENT'S PELVIS. IT WAS THE SURGEON'S FIRST PROSTATECTOMY PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM AND THE PROCEDURE WAS GOING SLOWLY, WITH THE SURGEON FIGHTING BOWEL THE ENTIRE CASE. NO SYSTEM MALFUNCTION OCCURRED AND ALL SURGICAL TASKS HAD BEEN PERFORMED CORRECTLY, HOWEVER, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE DUE TO THE LENGTH OF TIME IT WAS TAKING TO COMPLETE THE PROCEDURE. TWO DAYS POST-OP, THE PATIENT EXPIRED.

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 THAT DURING A DA VINCI S NEPHRECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING THE HILAR DISSECTION TECHNIQUE, THE PATIENT BEGAN TO HEMORRHAGE. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUE. DESPITE EFFORTS FROM THE SURGICAL STAFF, THE PATIENT HEMORRHAGING WAS NOT ABLE TO BE CONTROLLED AND THE PATIENT EXPIRED. BASED ON THE INFORMATION PROVIDED BY THE SITE, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM DID NOT MALFUNCTION AND DID NOT CONTRIBUTED TO THE PATIENT'S DEATH.

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 2009, INTUITIVE SURGICAL WAS FORWARDED VOLUNTARY REPORT BY THE FDA FOR A PT DEATH AT HOSPITAL. THE REPORT DETAILS ARE PROVIDED BELOW: CDRH MAUDE EVENT REPORT 2009. REPORT OUTCOME ATTRIBUTED TO EVENT: DEATH. DATE RECEIVED: 2009. EVENT DATE: 2009. EVENT DESCRIPTION THE FOLLOWING MONTH: HEALTHY FEMALE FOR OVARIAN CYSTECTOMY USING THE DAVINCI ROBOT. PT SUFFERED FATAL CARDIAC ARREST IN THE MIDDLE OF THE PROCEDURE. HISTORY OF HTN, BUT OTHER WISE HEALTHY. NO AUTOPSY DONE. DEVICE INFORMATION: BRAND: DAVINCI ROBOT. DEVICE OPERATOR: HEALTH PROFESSIONAL. DEVICE AVAILABLE FOR EVALUATION: Y. EXPIRATION DATE: IS REPORTER A HEALTH PROFESSIONAL?: Y.

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 WHO UNDERWENT A DA VINCI HEART VALVE REPAIR PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT DURING THE SURGERY, THE PATIENT EXPERIENCED INTERNAL BLEEDING AND INTERNAL BURNS OCCURRED. THE LEGAL DOCUMENT ALSO ALLEGES THAT THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE AFTER BLOOD VESSELS WERE DAMAGED. INTUITIVE SURGICAL, INC. (ISI) WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT MEDICAL RECORDS. BASED ON THE LEGAL DOCUMENT PROVIDED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

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 WHO REPORTEDLY UNDERWENT A DA VINCI-ASSISTED ROBOTIC PROCEDURE - NEPHRECTOMY FOR RENAL MASS ON (B)(6) 2008. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. ISI WAS ONLY PROVIDED A LEGAL CLAIM FORM. THE LEGAL DOCUMENT STATES THAT ON (B)(6) 2008, THE PATIENT UNDERWENT ROBOTIC SURGERY FOR REMOVAL OF A RENAL MASS. DURING THE ROBOTIC SURGERY THE ROBOT PERFORATED THE PATIENT'S ARTERY LEADING TO IS [SIC] OTHER KIDNEY. IN ADDITION, THE LEGAL DOCUMENT CLAIMS THAT AS A RESULT, THE PATIENT WAS NOT A CANDIDATE TO RECEIVE THE CANCER TREATMENT, INTERLEUKIN II, TO FIGHT HIS KIDNEY CANCER. THE PATIENT PASSED AWAY ON (B)(6) 2013 FROM METASTATIC RENAL CANCER. NO FURTHER 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: IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE TO REMOVE A PELVIC MASS, THE CONSOLE SURGEON UNINTENTIONALLY CLIPPED THE PT'S SUPERIOR MESENTERIC ARTERY. AFTER THE PROCEDURE WAS COMPLETED, THE PT WENT INTO ORGAN FAILURE WHILE ON THE FLOOR AND EXPIRED. NO ADDITIONAL INFO HAS BEEN 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: IT WAS REPORTED THAT AFTER A DA VINCI S MITRAL VALVE REPAIR SURGICAL PROCEDURE AND WHILE RE-INFLATION OF THE PT'S RIGHT LUNG, THE SURGICAL STAFF NOTICED A VERY LOW OXYGEN (O2) SATURATION. AS A RESULT OF THE LOW O2 SATURATION, THE SURGICAL STAFF DECIDED TO PUT THE PT ON BYPASS IN ORDER TO SCOPE THE LUNGS. THE SURGICAL STAFF FOUND THAT FLUID HAD ACCUMULATED IN THE PT'S RIGHT LUNG. DESPITE EFFORTS, THE PT WAS NOT ABLE TO REGAIN FUNCTION OF THE RIGHT LUNG AND WAS TRANSFERRED TO THE ICU. THE PT EXPIRED DUE TO MULTI-ORGAN FAILURE, HYPOXIA, AND ACUTE PULMONARY EDEMA OF THE RIGHT LUNG.

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 ESOPHAGOGASTRECTOMY FOR ESOPHAGEAL ADENOCARCINOMA ON (B)(6) 2008. A COMBINATION OF STANDARD LAPAROSCOPIC AND ROBOTIC ASSISTED LAPAROSCOPY WAS PERFORMED. THE SURGEON WENT BACK AND FORTH BETWEEN ROBOTIC ASSISTED AND NON-ROBOTIC LAPAROSCOPIC TECHNIQUE DEPENDING UPON WHICH TASKS WERE BEING ACCOMPLISHED. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUPPLEMENTAL HOSPITAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING ANY PORTION OF THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE BARRETT'S ESOPHAGUS CHANGES. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, THERE WERE ADHESIONS IN THE UPPER ABDOMEN, LEFT ABDOMEN AND RIGHT ABDOMEN. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT UN

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO CONCLUSION CAN BE DRAWN TO THE PRODUCT, AS IT HAS NOT BEEN RETURNED FOR EVALUATION.

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 MARCH 5, 2008, INTUITIVE SURGICAL WAS NOTIFIED PER A CUSTOMER PROVIDED LETTER: "THIS GENTLEMEN WAS DIAGNOSED WITH SEVERE MITRAL REGURGITATION. HE WAS ORIGINALLY EVALUATED FOR POSSIBLE CANDIDACY FOR TRANSMITRAL PERCUTANEOUS REPAIR. HE WAS TURNED DOWN DUE TO MITRAL ANATOMY. THE PT WAS REFERRED HERE FOR POSSIBLE ROBOTIC INTERVENTION AND AGREED TO PROCEED WITH THE SURGERY. INCIDENTLY, THE PT HAD A TEE WHICH REVEALED A VERY CALCIFIED VALVE WITH SEVERE MITRAL VALVE REGURGITATION AND FAIR OVERALL EJECTION FRACTION ABOUT 50%. THE PROCEDURE WAS PERFORMED ROBOTICALLY, INITIALLY WITH FAILURE OF THE MITRAL VALVE REPAIR NECESSITATING FURTHER BYPASS AND MITRAL RING ANNULOPLASTY, WHICH ALSO FAILED-NECESSITATING MITRAL VALVE REPLACEMENT. MULTIPLE TRANSFUSIONS WERE GIVEN INTRAOPERATIVELY (PRBC, 16 UNITS, PLASMA-14 UNITS, CRYO-40 UNITS, PLATELETS-90 UNITS). THE PT WAS IN THE OPERATING ROOM FROM 8:30AM-12 MIDNIGHT. ULTIMATELY, THE PT DEVELOPED LOW CARDIAC OUTPUT, CARDIOGENIC SHOCK AND UNCONTROLLABLE BLEEDING DIATHESIS. DEMISE AT 16:35."

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 2008, AFTER A SINGLE VESSEL SMALL THORACOTOMY DA VINCI S PROCEDURE, THE PATIENT EXPIRED WHILE WEANING OFF OF BYPASS. PRIOR TO THE PROCEDURE, THE PATIENT APPEARED TO HAVE A HEPARIN REACTION AND EXPERIENCED A HYPOTENSIVE EVENT WITH A SYSTOLIC PRESSURE OF 39MM. THE SITE INITIATED A CARDIOPULMONARY BYPASS RUN AND COMPLETED THE PROCEDURE WITHOUT EVENT. WEAN FROM BYPASS WAS UNSUCCESSFUL AS PATIENT EXHIBITED STONE HEART CHARACTERISTICS. NO MALFUNCTION OF THE DAVINCI S SYSTEM WAS ALLEGED BY THE HOSPITAL, AND THE INFORMATION PROVIDED INDICATES THAT THIS EVENT IS RELATED TO THE INHERENT RISKS ASSOCIATED WITH BYPASS AND THE PATIENT'S MEDICAL HISTORY.

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 JANUARY 17, 2008, INTUITIVE SURGICAL WAS NOTIFIED THAT FOLLOWING A DA VINCI S HYSTERECTOMY SURGICAL PROCEDURE, THE PT SUFFERED FROM SEPSIS AND EXPIRED FOUR DAYS POST DA VINCI ASSISTED SURGERY.

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 WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND UMBILICAL HERNIA REPAIR ON (B)(6) 2007. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT THE DA VINCI SURGICAL PROCEDURE WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS. PER THE MEDICAL RECORDS, THE PATIENT WAS STARTED ON LEVAQUIN ON POST-OP DAY 2 FOR POSSIBLE CELLULITIS. SHE HAD SLOW RETURN OF BOWEL FUNCTION. THE PATIENT WAS ONLY PASSING SMALL AMOUNTS OF GAS THROUGHOUT THE FIRST FEW DAYS OF HER HOSPITAL COURSE AND FELT VERY UNCOMFORTABLE GOING HOME. HER BOWEL REGIMEN WAS INITIATED ORALLY AND RECTALLY ON POST-OP DAY 4 AND BEGAN TO PASS GAS ON POST-OP DAY 5. SHE HAD A SMALL BOWEL MOVEMENT AND BY POST-OP DAY 6 FELT VERY COMFORTABLE GOING HOME. THE PATIENT WAS DISCHARGED ON (B)(6) 2007. ON (B)(6) 2008, THE PATIENT WAS SEEN IN AN ER FOR ABDOMINAL PAIN. THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS

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 (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER RC20155000211) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON 04/23/2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FR

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT UNDERWENT ROBOTIC TECAB (TOTALLY ENDOSCOPIC CORONARY ARTERIES BYPASS) WITH 2 INTERNAL MAMMARY ARTERIES, USING THE DA VINIC S ROBOT AND COALESCENT "U" CLIPS TO FACILITATE DISTAL ANASTOMOSES, ON A BEATING HEART. ON CORONARY ANGIOGRAPHY 5 DAYS LATER, THERE WAS 80% STENOSIS OF ONE DISTAL ANASTOMOSIS, AND 40% STENOSIS OF ANOTHER.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTEMPTED TECAB (TOTALLY ENDOSCOPIC CORONARY ARTERY BYPASS) SURGERY USING THE DEVINIC S ROBOT AND FACULATED BY THE COALESENT U CLIP ON A BEATING HEART. ONLY 2 OUT OF 4 ARTERIES WERE BYPASSED. PT ARRESTED AT THE KIND OF THE PROCEDUSE. CPR WAS INITIATED AND THE CHEST OPENED . PT WAS CONNECTED TO CADIOPULOMONARY BYPASS AND ADDITIONAL BYPASS GRAFTS PERFORMED. PT DIED ON THE OPERATING ROOM TABLE.

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 IN (B)(4) THAT THE SIDE RAIL WAS DAMAGED ON WELDING.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDWATCH UF/IMPORTER REPORT WAS REC'D AT ISI ON SEPTEMBER 28, 2007. INTUITIVE SURGICAL WAS PREVIOUSLY INFORMED OF THIS EVENT ON JULY 25, 2007. IT WAS ALSO REPORTED THAT THE PT WAS LATER BROUGHT BACK TO THE OR IN 2007, TO DRAIN CLOTS WHICH HAD FORMED, HOWEVER, THE DA VINCI SYS WAS NOT USED FOR THIS PROCEDURE. THE PT DIED FOUR DAYS POST DA VINCI ASSISTED SURGERY.

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 — 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 — 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 — 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 — 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.

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 — 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 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.

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.

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 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.

An employee was tearing down a tested robot line for shipment. He pulled the bus fuses for one line, then began work in the control panel of an adjacent line. He contacted 480-volt parts in the control panel and was electrocuted.

Employee #1 was inside a chiron making adjustments to a wheel size changeover. A robot is used to move the wheel around the cell. Employee #1 was holding the robot controls in his hands, and apparently activated the robot while bending over the wheel to check the settings. The robot came into the chiron unit to remove the wheel, but instead pinned Employee #1 against the wheel, crushing him to death.

Employee #1, the operator of a robot, went to investigate and/or fix a malfunction in the robot without locking it out. When Employee #1 tried to fix the system, he activated the robot and the robot's arm crushed him against a part being transported on a conveyor. Employee #1 was killed.

Employee #1, who had been employed by Bay Mirror, Inc. for 1 1/2 years, leaned over the end of the mirror production roll line to brush off a piece of broken glass. This was not part of his or anyone's duties. This action placed him in the return path of a twin-armed robot mirror unloader conveyor. The arms follow a 90 degree arc of descent, then travel into 9 1/2 inch wide spaces in the end of the roll line, ending in a horizontal position, parallel to the roll line and floor. Employee #1 was struck in the back of the head and back, and pushed into the 9 1/2 inch space with the robot arm on top of him. He was pronounced dead of internal injuries at the hospital, although no pulse was achieved by emergency response personnel at the site. Employee #1 was actually inside the travel rails of the robot, according to management, when he leaned over. An emergency stop was pushed within 10 seconds. The employee's presence in the hazard area was not necessary to his assigned job, although the area was not guarded and there were no warning signs. A serious accident related violation of 4002(a) was cited.

Employee #1 was working with an industrial robot that takes parts from a conveyor, feeds them into a machining operation; takes the parts and inserts them into a multi-spindle drill press; and then puts them on a spray painting turntable for rust-proofing. Employee #1 had apparently replaced a drill bit and returned to production but, because the parts didn't properly contact locator switches on the drill, the robot stopped. (This was a common problem.) Employee #1 apparently then reentered the robot area without locking out or hitting the "system stop" button or pushing the "hold" button. The "system stop" button can be hit earlier in the cycle before hitting "hold," and was found to override the "hold." Apparently Employee #1 pushed the parts against the locator switches that automatically activated the robot and the robot inadvertently crushed Employee #1 against the drill press. Employee #1 died. The original interlocked gate guards had been damaged over time, removed, and not replaced.

EMPLOYEE #1 CLIMBED ONTO THE CHIP JAW OF AN AUTOMATIC LATHE. WHILE HE WAS CHANGING THE CUTTING TOOL TIPS THE PRODUCT HANDLING ROBOT MOVED. HE WAS CRUSHED AGAINST THE HEAD STOCK OF THE LATHE.