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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER A DA VINCI HYSTERECTOMY PROCEDURE, DURING THE CYSTOSCOPY, IT WAS FOUND THAT THE PATIENT'S URETER HAD BEEN DAMAGED. THE URETER WAS REPAIRED VIA A URETERONEOCYSTOTOMY PROCEDURE, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL PATIENT HARM 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: IT WAS REPORTED THAT 8 DAYS AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT UNDERWENT AN EXPLORATORY LAPAROSCOPY PROCEDURE WHERE A BOWEL PERFORATION WAS DISCOVERED. THE PERFORATION WAS REPAIRED, HOWEVER, THE PT BECAME SEPTIC DUE TO A BILIOUS FLUID LEAKAGE. THE PT WAS IN CRITICAL CARE FOR 2 WEEKS AND WAS THEN TRANSFERRED TO LONG TERM CARE. NO ADD'L PT HARM OR ADVERSE OUTCOME WAS REPORTED.

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 — 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.