da Vinci Surgical System — Injury 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 BEATING HEART DOUBLE VESSEL CORONARY ARTERY BYPASS GRAFT PROCEDURE AT THE HOSPITAL, THERE WAS AN UNEXPLAINED MOVEMENT ON THE SYSTEM ARM WHICH HAD THE ENDOWRIST STABILIZER INSTRUMENT ATTACHED TO IT. THE UNEXPECTED MOVEMENT CAUSED THE FEET AT THE DISTAL END OF THE ENDOWRIST STABILIZER INSTRUMENT TO TIP DOWNWARD RESULTING IN DAMAGE TO THE MYOCARDIUM OF THE PATIENT'S LEFT VENTRICLE. THE SURGICAL TEAM IMMEDIATELY CONVERTED TO AN OPEN STERNOTOMY TO SUCCESSFULLY REPAIR THE DAMAGED VENTRICLE WITH A SINGLE MEDTRONIC U-CLIP S50. THE PATIENT WAS REPORTED AS RECOVERING WELL WITH NO POST-OPERATIVE COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT TOWARDS THE END OF A DA VINCI S GYNECOLOGIC DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE ASSISTANT SURGEON PLACED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INSIDE OF THE PT'S BODY AND WAS MOVING THE INSTRUMENT OUTSIDE OF THE FIELD OF VIEW. THE CONSOLE SURGEON TOOK CONTROL OF THE INSTRUMENT WITHOUT HAVING A VISUAL OF WHERE THE INSTRUMENT WAS LOCATED AND ACTIVATED THE INSTRUMENT TIP, WHICH CREATED A TRANSECTION CUT TO THE PT'S RIGHT INTERNAL ILIAC ARTERY AND RIGHT URETER. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES AND A VASCULAR SURGEON AND UROLOGIST WERE CALLED IN TO REPAIR THE PT'S RIGHT INTERNAL ILIAC ARTERY AND STENT THE URETER. A BLOOD TRANSFUSION WAS REQUIRED DURING THE REPAIR SURGERY. IT WAS REPORTED THAT THE PT IS RECOVERING AS PLANNED POST-OPERATIVE DAY 27.

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 7/11/08, ISI RECEIVED MEDWATCH REPORT, WHICH INDICATES THAT AN ADVERSE EVENT OCCURRED IN '08, DURING THE USE OF THE DA VINCI S SURGICAL SYSTEM AND A GYNECARE X-TRACT TISSUE MORCELLATOR IN A SURGICAL PROCEDURE. THE REPORT WAS SUBMITTED TO THE FDA BY THE PT, HOWEVER, A DESCRIPTION OF THE EVENT WAS NOT 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: IN 2008, IT WAS REPORTED THAT THE SITE EXPERIENCED A SYSTEM FAULT WHILE SETTING UP FOR A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE. NO PT ISSUES WERE REPORTED AT THAT TIME. ON 7/3/08, ADDITIONAL INFO WAS RECEIVED FROM THE ATTENDING SURGEON WHO INDICATED THAT CONTINUOUS SYSTEM FAULTS OCCURRED AFTER THE PT PORTS WERE PLACED, RESULTING IN A 1 HOUR DELAY. DURING THE DELAY, THE PT'S ABDOMEN BECAME DEFLATED AND THE PT BUCKED VERTICALLY. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER VIA TELEPHONE, THE SYSTEM FAULTS WERE RESOLVED BY CLEANING THE FIBEROPTIC CABLE AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE PT RETURNED TO THE OPERATING ROOM THREE DAYS AFTER THE PROCEDURE WAS PERFORMED WITH THE SYSTEM AND A SMALL BOWEL LACERATION WAS DISCOVERED AND REPAIRED. IT IS BELIEVED THAT THE SMALL BOWEL LACERATION WAS CAUSED AT SOME POINT IN THE PROCEDURE ON 4/1/08, WHEN THE INJURED AREA OF THE BOWEL WAS NOT IN VIEW. THIS COULD HAVE OCCURRED DURING INITIAL PLACEMENT OF THE SURGICAL PORTS, WHEN THE PT BUCKED ON THE TABLE AND THE TROCARS WERE STILL INSTALLED DURING THE SYSTEM DELAY, DURING MANIPULATION OF THE BOWEL, OR DURING AN UNOBSERVED INSERTION OF A DA VINCI S OR ASSISTANT INS

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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE END OF A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE THE SURGICAL STAFF NOTICED A "DRIED OR BURN-LIKE" AREA AROUND THE CAMERA PORT INCISION, APPROX 2MM IN WIDTH. THE DAMAGED SKIN HAD TO BE CUFF OFF IN ORDER TO CLOSE THE INCISION. NO VISUAL DAMAGE NOR SIGNS OF MELTING WERE OBSERVED ON THE CANNULA ACCESSORY USED IN CONJUNCTION WITH THE CAMERA.

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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 04/08/2010, ISI RECEIVED VOLUNTARY MEDWATCH (B)(4) FROM THE FDA DEPARTMENT OF HEALTH AND HUMAN SERVICES REPORTING THE FOLLOWING: VOLUN 01-FEB-2010: MY NAME IS (B)(6). I AM THE PERSONAL REP OF THE ESTATE OF (B)(6), ON (B)(6) 2007, MY MOTHER HAD A DAVINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) MEDICAL CENTER IN (B)(6). IT IS MY UNDERSTANDING THAT DURING THIS EVENT, DR (B)(6) LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULONARY ARREST AND NEAR EXSAGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS A MAUDE ADVERSE EVENT ASSOCIATED WITH THE DAVINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN: (B)(6) MD. FACILITY: (B)(6) MEDICAL CENTER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING INFORMATION RELATED TO THE FIELDS IN (B)(6).

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 MARCH 12, 2010, ISI RECEIVED MAUDE EVENT REPORT (B) (4) WITH THE FOLLOWING EVENT DESCRIPTION: MY NAME IS XXX. I AM THE PERSONAL REP OF THE ESTATE OF XXX ON XX XX 2007, MY MOTHER HAS A DA VINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT XXX MEDICAL CENTER IN XXX. IT IS MY UNDERSTANDING THAT DURING THIS EVENT DR XXX LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULMONARY ARREST AND NEAR EXSANGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS AN MAUDE ADVERSE EVENT ASSOCIATED WITH THE DA VINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN XXX. MEDICAL FACILITY XXX. NO ADDITIONAL INFORMATION WAS PROVIDED.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 04/11/2013 WHILE READING A DRAFT RESEARCH PAPER ENTITLED "STEREOTACTIC BODY RADIATION THERAPY FOR HEPATOCELLULAR CARCINOMA; PROGNOSTIC FACTORS OF LOCAL CONTROL, OVERALL SURVIVAL, AND TOXICITY"; AN ACCURAY EMPLOYEE BECAME AWARE OF AN ADVERSE EVENT. THIS STUDY IS PARTIALLY FUNDED BY ACCURAY. THE PAPER REPORTS THAT THREE MONTHS AFTER A CYBERKNIFE TREATMENT FOR A TUMOR IN THE LIVER, ONE PATIENT EXPERIENCED A GRADE 4 GASTRIC ULCER, RESULTING IN A DIGESTIVE HEMORRHAGE, WHICH WAS TREATED. THE PAPER REPORTS FOLLOWING THE ADVERSE OUTCOME "TREATMENT PLANS WERE REVIEWED AND STRICT CONSTRAINTS WERE DEFINED FOR SUBSEQUENT TREATMENTS." THE PRINCIPLE INVESTIGATOR CONFIRMED THE CYBERKNIFE DID NOT MALFUNCTION.

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

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

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.

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.

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