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 MAY 30, 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A JOURNAL ARTICLE TITLED,THE NEPHROMETRY SCORE: IS IT EFFECTIVE FOR PREDICTING PERIOPERATIVE OUTCOME DURING ROBOT-ASSISTED PARTIAL NEPHRECTOMY? THIS ARTICLE IS FROM KOREAN JOURNAL OF UROLOGY, PUBLISHED IN 2014. ACCORDING TO THE REPORTED ARTICLE, PERIOPERATIVE COMPLICATIONS OCCURRED IN 16 PATIENTS, INCLUDING 6 PERIRENAL ORGAN INJURIES, 2 OPEN CONVERSIONS, 3 WOUND COMPLICATIONS, AND 3 GROSS HEMATURIA CASES. ORGAN INJURY CASES CONSISTED OF TWO RENAL VEIN LACERATIONS, TWO SPLEEN INJURIES, AND ONE LIVER AND COLON INJURY. TWO OPEN CONVERSIONS WERE DETERMINED OWING TO DIFFICULTY IN APPROACHING THE ISOLATED RENAL TUMOR AND A TOO SMALL PERITONEAL CAVITY FOR ROBOT CONTROL, RESPECTIVELY. POSTOPERATIVELY, THERE WERE THREE HEMATURIA AND TRANSFUSION CASES, ONE WOUND PROBLEM, ONE ILEUS, AND ONE MINOR PROBLEM RANKED AS CLAVIEN GRADE I OR II. THE MAJOR POSTOPERATIVE COMPLICATIONS CLASSIFIED AS CLAVIEN GRADE III WERE TWO OTHER WOUND PROBLEMS THAT NEEDED REPAIRING AND ONE CASE OF ABDOMINAL FLUID COLLECTION THAT REQUIRED PERCUTANEOUS DRAINAGE. UNIVARIATE AND MULTIVARIATE ANALYSES REVEALED THAT NO PARAMETER HAD A SIGNIFICANT CORRELATION WITH PERI

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 A PATIENT UNDERWENT A DA VINCI LOBECTOMY PROCEDURE AND THE CASE WAS CONVERTED TO OPEN DUE TO BLEEDING. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SURGEON AND WAS INFORMED THAT THE PATIENT DID NOT TOLERATE THE PROCEDURE WELL AND DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE 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: IT WAS REPORTED THAT POST A DA VINCI LOW ANTERIOR RESECTION (LAR) PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT PRESENTED SYMPTOMS OF AN ANASTOMOTIC LEAK ON (B)(6) 2014, REQUIRING THE PATIENT TO UNDERGO A SURGICAL PROCEDURE TO REPAIR THE LEAK AND A COLOSTOMY. DURING THE SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEERING (TSE) DUE TO EXPERIENCING ARTICULATION ISSUES WITH THE PATIENT SIDE MANIPULATOR (PSM) ARM 1. THE SITE TOLD THE TSE THAT THEY RESEATED THE STERILE ADAPTER SEVERAL TIMES, BUT DID NOT REPLACE THE DRAPE. THEY ALSO INSTALLED OTHER INSTRUMENTS; HOWEVER THE ISSUE PERSISTED. WITH THE ASSISTANCE OF THE TSE, THE SITE STOWED PSM 1 AND COMPLETED THE PLANNED PROCEDURE USING PSM 2 AND PSM 3. AFTER SOME TIME, THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE, CALLED BACK ISI TSE AND REPORTED THAT WHEN SHE CLUTCHED AND MOVED PSM 1, IT BARELY MOVED. ON (B)(6) 2014, A FIELD INVESTIGATION WAS PERFORMED BY THE ISI FIELD SERVICE ENGINEER (FSE). THE FSE WAS ABLE TO REPLICATE THE ISSUE WITH THE PSM EXPERIENCED BY THE SITE. DURING FUNCTIONAL TESTING, AFTER PERFORMING AN EMERGENCY-STOP AND FAULT OVERR

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: KIDNEY CYST RESECTION WITH DA VINCI ROBOTIC DEVICE AT VIA (B)(6). SURGEON INADVERTENTLY AVULSED A VEIN OR ARTERY WHICH CAUSED MASSIVE BLEED AND PRESSURE DROPS. SURGEON BEGAN USING THE ROBOT'S STAPLING DEVICE TO CONTROL THE BLEED. DURING ONE OF THOSE ATTEMPTS, A STAPLE WAS INADVERTENTLY PLACED ACROSS THE PATIENT'S ABDOMINAL AORTA. UNFORTUNATELY THIS WAS NOT DISCOVERED UNTIL AFTER THE SURGERY SEVERAL HOURS LATER. ONCE IT WAS DETERMINED THAT THE PATIENT HAD NO BLOOD FLOW BELOW HER ABDOMINAL AORTA, SHE WAS TAKEN BACK TO SURGERY WITH A VASCULAR SURGEON. THAT SURGEON REMOVED THE STAPLED PART OF THE AORTA AND CREATED A BYPASS. UNFORTUNATELY THE PATIENT HAD RECEIVED SO MANY UNITS OF BLOOD SHE WAS UNABLE TO CLOT AND DEVELOPED A COAGULOPATHY WHICH LED TO HER DEATH ON THE SURGERY 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 THAT DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON ENCOUNTERED HEAVY BLEEDING FROM THE PATIENT AND DUE TO THE EXTENSIVE BLEEDING EXPERIENCED BY THE PATIENT THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. LATER THAT NIGHT, THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM (OR) AND A VASCULAR SURGEON WAS CONSULTED. ACCORDING TO THE SURGEON IT IS THE HOSPITAL'S BELIEF THAT THE PATIENT'S AORTA HAD BEEN NEARLY STAPLED ACROSS. THE PATIENT EXPIRED IN THE OR. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT REGARDING THE REPORTED EVENT. ACCORDING TO THE SITE'S RISK MANAGER, THE HOSPITAL'S INVESTIGATION IS ONGOING; HOWEVER, THEIR INVESTIGATION THUS FAR HAS DETERMINED THAT THE INTRA-OPERATIVE BLEEDING EXPERIENCED BY THE PATIENT AND FINAL PATIENT OUTCOME WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE RISK MANAGER INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE PLANNED SURGICAL PROCEDURE. THE RISK MANAGER INDICATED THAT HE WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING THE

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 AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT'S VAGINAL CUFF AND AN UNSPECIFIED VEIN ALLEGEDLY TORE OPEN ON POST-OPERATIVE DAY 18. DUE TO ALLEGEDLY LOSING SIGNIFICANT BLOOD, THE PATIENT INDICATED THAT SHE RECEIVED DAILY TRANSFUSIONS FOR SEVEN STRAIGHT DAYS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, THE PATIENT CLAIMED THAT SHE HAS SUFFERED FROM MENTAL HEALTH CHALLENGES. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5070734 ON 07/14/2017 WITH THE FOLLOWING EVENT DESCRIPTION: STATUTE OF LIMITATIONS ENDS FRIDAY (B)(6) 2017. PLEASE HELP! (B)(6) ATTORNEY (B)(6) HAS BEEN LOOKING ALL OVER THE COUNTRY FOR AN OPEN CLASS ACTION LAWSUIT OR SOMEONE WHO HAS DONE SUFFICIENT RESEARCH ON THE DA VINCI ROBOT TO HELP. I HAD A HYSTERECTOMY USING THE DA VINCI ROBOT ON (B)(6) 2014. ON (B)(6) 2014, THE VAGINAL CUFF TORE OPEN, ALONG WITH A VEIN. I LOST SIGNIFICANT BLOOD. SO MUCH THAT ONE OF THE TRAUMA NURSES AND MY MOTHER HAD ME SIGN A STATEMENT SAYING WHO WOULD GET MY DAUGHTER AND WITNESSED IT. THE NURSE WHO WITNESSED MY SIGNATURE, (B)(6), TOLD ME LATER THAT SHE WAS SHOCKED TO SEE ME ALIVE. IN ALL H

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 ALLEGEDLY SUSTAINED AN INJURY DURING A DA VINCI HYSTERECTOMY AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION 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: I HAD A HYSTERECTOMY WITH THE DA VINCI SURGICAL ASSISTANT AND MY DUODENUM WAS PUNCTURED RESULTING IN A PELVIC ABSCESS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE DEATHS. THESE ALLEGATIONS WERE FIRST RECEIVED BY INTUITIVE SURGICAL DURING THE TIME PERIOD OF (B)(6) 2013 TO (B)(6) 2014. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2013.

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 POST A DA VINCI SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN ANASTOMOTIC LEAK. NO OTHER INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT.

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 EXTRA FASCIAL HYSTERECTOMY AND RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2014 FOR UNSTAGED ADENOCARCINOMA OF THE ENDOMETRIUM. DURING THE SAME PROCEDURE, THE PATIENT ALSO UNDERWENT A DIAGNOSTIC LAPAROSCOPY, WASHINGS, LYSIS OF ADHESIONS, AND PELVIC SENTINEL LYMPH NODE REMOVAL. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT IN ADDITION TO PATIENT MEDICAL AND LEGAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A LEGAL DOCUMENT PROVIDED CLAIMS THAT THE SURGEONS CUT, NICKED, TORE, BURNED OR OTHERWISE DISRUPTED THE SIGMOID COLON IN ONE OR MORE LOCATIONS. IN ADDITION, THE LEGAL DOCUMENT NOTES, IN AN ATTEMPT TO REPAIR ONE OF THE INJURIES TO THE SIGMOID COLON, THE SURGEONS PLACED SUTURES. PER THE DA VINCI OPERATIVE REPORT, OPERATIVE FINDINGS INCLUDED THE FOLLOWING: THE LAPAROSCOPY REVEALED SOME PERIHEPATIC ADHESIONS. SHE HAD SOME ADHESIONS IN THE PELVIC AREA IN THE SITE OF HER PREVIOUS SURGERY. BIOPSY FROM THIS AREA SHOWED GRANULATION TISSUE WITH NO OBVIOUS M

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 DAVINCI ASSISTED LEFT UPPER LOBECTOMY, THE SURGEON PLACED A LARGE HEM-O-LOK CLIP ON THE PULMONARY ARTERY AND CLIPPED IT. THE CLIP DID NOT RELEASE FROM THE INSTRUMENT, WHEN THE INSTRUMENT WAS PULLED BACK THE CLIP TORE THE ARTERY. AS A RESULT THE CASE CONVERTED TO AN OPEN PROCEDURE.

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 CHOLECYSTECTOMY PROCEDURE, THE ELECTROSURGICAL UNIT (ESU) MISFIRED AND THE PATIENT SUSTAINED AN EXTERNAL BURN. SPECIFIC DETAILS REGARDING THE BURN WERE NOT PROVIDED. ON THE SAME DAY THE EVENT OCCURRED, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE EVALUATED THE DA VINCI SURGICAL SYSTEM AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE TESTED THE SYSTEM USING THE ORIGINAL MONOPOLAR CABLE AND GROUNDING PAD USED DURING THE REPORTED EVENT. NO ISSUES WERE FOUND WITH THE ENERGY PEDAL ON THE SURGEON SIDE CONSOLE (SSC). THE FSE WAS ABLE TO SIMULATE CAUTERY ON THE DA VINCI SURGICAL SYSTEM USING A SPONGE SOAKED IN SALT WATER. THE FSE ALSO VERIFIED THAT WITH THE DA VINCI INSTRUMENT REMOVED OR WITH THE HEAD SENSOR BLOCKED, THE SSC WOULD NOT ACTIVATE THE ESU. THE FSE REVIEWED SITE'S SYSTEM ERROR LOGS. NO ERRORS RELATED TO THE SSC AND PERSONALITY MODULE ENERGY DEVICE (PMED) WHERE THE ESU IS PLUGGED INTO WERE FOUND. THE FSE THEN TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(4) 2014, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS NOT PRESENT DURING T

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 HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE SURGEON NOTICED A SLIGHT HOLE IN THE PATIENT'S BLADDER. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGERY LASTED ABOUT 1 HOUR AND 40 MINUTES. THE PATIENT WAS READMITTED ON (B)(6) 2014 AND WAS FOUND TO HAVE A PELVIC ABSCESS. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE AND NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. A FEW DAYS AFTER THE DA VINCI HYSTERECTOMY PROCEDURE WAS COMPLETED, THE PATIENT RETURNED TO THE HOSPITAL AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS FOUND TO HAVE A PELVIC ABSCESS, HIGH FEVER, AND AN ELEVATED WHITE BLOOD CELL (WBC) COUNT. NO ADDITIONAL POST-OPERATIVE COMPLICATIONS WERE REPORTED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S DIRECTOR OF SURGICAL SERVICES. ACCORDING TO THE DIRECTOR OF SURGICAL SERVICES, THE BLADDER INJURY WAS CAUSED BY SURGEON ERROR AND WAS SUCCESSFULLY REPAIRED BY THE SURGEON USING 2-3 STITCHES DURING THE DA VINCI HYSTERECTOMY PROC

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 AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON WHO PERFORMED THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT UNDERWENT A DA VINCI SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT EXPERIENCED SYMPTOMS OF A POST-SURGICAL LEAK. THE PATIENT HAD A SMALL LEAK NEAR THE GASTROESOPHAGEAL (GE) JUNCTION, PRESUMABLY FROM THE STAPLE LINE. THE SURGEON INDICATED THAT INITIALLY IT WAS BELIEVED THAT THE PATIENT HAD AN INFECTED HEMATOMA. PERCUTANEOUS DRAINS WERE PLACED BY RADIOLOGY TO RESOLVE THE ABDOMINAL FLUID COLLECTIONS. AFTER THE PERCUTANEOUS DRAINS WERE REMOVED, THE ISSUE RECURRED. ON (B)(6) 2014 THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION AND DRAIN PLACEMENT; HOWEVER, THE LEAK WAS NOT LOCATED. LATER IN THE PATIENT'S COURSE SHE UNDERWENT A PROCEDURE TO HAVE A STENT PLACED TO COVER THE LEAK FROM INSIDE OF THE STOMACH. ACCORDING TO THE SURGEON, AS OF (B)(6) 2014, THE PATIENT WAS IN THE HOSPITAL AND IN STABLE CONDITION. THE SURGEON INDICATED THAT THE

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 HYSTERECTOMY PROCEDURE, THE ASSISTING SURGEON ATTEMPTED TO REMOVE A NEEDLE THROUGH A LAPAROSCOPIC ASSIST PORT AND THE NEEDLE WAS LOST. AFTER THE VAGINAL CUFF WAS CLOSED, THE ROBOT WAS UNDOCKED FROM THE PATIENT. THE NEEDLE WAS FOUND IN THE ABDOMINAL WALL AFTER AN X-RAY WAS PERFORMED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. TOWARDS THE END OF THE SURGICAL PROCEDURE WHILE THE SURGEON WAS CLOSING THE VAGINAL CUFF, THE ASSISTING SURGEON ATTEMPTED TO REMOVE A NEEDLE THROUGH A LAPAROSCOPIC ASSIST PORT USING AN UNIDENTIFIED NON-ISI LAPAROSCOPIC INSTRUMENT AND WITHOUT DIRECT VISUALIZATION. THE INITIAL REPORTER STATED THAT THE LAPAROSCOPIC ASSIST PORT WAS ACTUALLY A DA VINCI PORT BUT WAS SOLELY USED AS A LAPAROSCOPIC ASSIST PORT BY THE SURGICAL STAFF. THE INITIAL REPORTER INDICATED THAT THE DA VINCI SURGICAL SYSTEM WAS NEVER DOCKED TO THE LAPAROSCOPIC ASSIST PORT INVOLVED WITH THIS COMPLAINT. AFTER THE ASSISTING SURGEON REMOVED THE LAPAROSCOPIC INSTRUMENT FROM T

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 SINGLE-SITE DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT'S URETER WAS TRANSECTED. REPORTEDLY, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED PROCEDURE USING THE DA VINCI SURGICAL SYSTEM. A UROLOGIST WAS CONSULTED TO REPAIR THE DEFECT TO THE PATIENT'S URETER. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, HE WAS PRESENT DURING THE SURGICAL PROCEDURE. THE DAMAGE TO THE PATIENT'S URETER WAS IDENTIFIED IMMEDIATELY AND HE HEARD THE SURGEON COMMENT THAT THE DAMAGE TO THE PATIENT'S URETER OCCURRED BECAUSE THE PATIENT HAD AN UNUSUAL ANATOMY. AFTER COMPLETION OF THE ROBOTICS PROCEDURE THE DECISION WAS MADE TO REPAIR THE DAMAGE TO THE PATIENT'S URETER USING OPEN SURGICAL TECHNIQUES. THE CSR INDICATED THAT HE WAS NOT PRESENT DURING THE OPEN 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: IT WAS REPORTED THAT DURING THE FIRST HOUR OF THE DA VINCI ADRENALECTOMY PROCEDURE, THE SURGEON NICKED A BRANCH OF A RENAL VEIN. THE SURGEON WAS ABLE TO CONTROL BLEEDING THAT ENSUED BY USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) 2. THE SURGEON THEN MADE THE DECISION TO CONVERT THE DA VINCI ADRENALECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES IN ORDER TO SUTURE THE VESSEL. AT AN UNSPECIFIED TIME DURING THE REMAINDER OF THE OPEN SURGICAL PROCEDURE, THE PATIENT'S VENA CAVA WAS INJURED. THE PATIENT WAS THEN TRANSPORTED TO ANOTHER FACILITY AND SUBSEQUENTLY PASSED AWAY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON INDICATED THAT THE CAUSE OF THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S RENAL ARTERY WAS NICKED BY THE SURGEON. HOWEVER, SHE STATED THAT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUM

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MY GYNECOLOGIST RECOMMENDED THE DA VINCI TO ME. SHE SAID IT WAS THE WAY TO GO. ON (B)(6) 2014, I HAD MY PLANNED SURGERY BUT I NEVER RECOVERED. I WAS NAUSEATED THE FIRST WEEK ((B)(6) BACK TO WORK, SO I HAD CALLED AND ASKED FOR SOMETHING TO CONTROL THE NAUSEA. I HAD NO BLADDER CONTROL BEGINNING (B)(6). I HAD A WETTING ACCIDENT AT WORK. I THOUGHT I HAD A BAD UTI. I KEPT CALLING MY DR'S OFFICE AND FINALLY GOT IN TO SEE HER AND SHE REFERRED ME THE SAME DAY TO A UROLOGIST. I HAD TO WEAR ADULT DIAPERS SINCE (B)(6). ON (B)(6) 2014 MET WITH A UROLOGIST ON A FRIDAY, AND HE TOLD ME THAT HE NEEDED TO SEE ME IN THE OPERATING ROOM ON THE FOLLOWING MONDAY TO PLACE A STENT IN. THE RIGHT URETER HAD STOPPED WORKING. ON (B)(6) 2014 THE STENT WAS REMOVED. SIX DAYS LATER, (B)(6) 2014, I FELL ILL AT WORK. MY STOMACH HAD SWELLED AND I COULD HEAR WATER GUSHING THROUGH MY STOMACH. I CALLED MY DOCTOR. HE SAID GO GET MRI AT THE HOSPITAL AND BRING HIM THE DVD. I WAS IN HIS OFFICE AT 1:30 AND HE SAID I NEED TO SEE YOU IN THE OPERATING ROOM AT 2:00. I HAD FLUID BACKING UP IN THE RIGHT KIDNEY. ON (B)(6), DR (B)(6) REPLACED THE STENT. ON (B)(6) 2014, I WENT TO (B)(6) FOR A SECOND OPINION. THE DOCTOR THERE SAID "Y

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 AS A RESULT OF UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT CLAIMED THAT HER RIGHT URETER WAS BURNED, NICKED, OR CUT. IN RELATION TO THE REPORTED EVENT, ON 01/07/2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5058544 WITH THE FOLLOWING EVENT DESCRIPTION: MY GYNECOLOGIST RECOMMENDED THE DA VINCI TO ME. SHE SAID IT WAS THE WAY TO GO. ON (B)(6) 2014, I HAD MY PLANNED SURGERY BUT NEVER RECOVERED. I WAS NAUSEATED THE FIRST WEEK (B)(6) BACK TO WORK, SO I HAD CALLED AND ASKED FOR SOMETHING TO CONTROL THE NAUSEA. I HAD NO BLADDER CONTROL BEGINNING (B)(6) . I HAD A WETTING ACCIDENT AT WORK. I THOUGHT I HAD A BAD UTI. I KEPT CALLING MY DR'S OFFICE AND FINALLY GOT IN TO SEE HER AND SHE REFERRED ME THE SAME DAY TO A UROLOGIST. I HAD TO WEAR ADULT DIAPERS SINCE (B)(6). ON (B)(6) 2014 MET WITH A UROLOGIST ON A FRIDAY, AND HE TOLD ME THAT HE NEEDED TO SEE ME IN THE OPERATING ROOM ON THE FOLLOWING MONDAY TO PLACE A STENT IN. THE RIGHT URETER HAD STOPPED WORKING. ON (B)(6) 2014 THE STENT WAS REMOVED. SIX DAYS LATER, (B)(6), I FELL ILL AT WORK. MY STOMACH HAD SWELLED AND I COULD HEAR WATER GUSHING THROUGH MY STOMACH. I CALLED MY DOCTOR

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 LEFT SALPINGO-OOPHORECTOMY PROCEDURE, THE PATIENT SUSTAINED A BOWEL INJURY THAT THE SURGEON FELT WAS LIKELY DUE TO A THERMAL ISSUE. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT THE PATIENT WAS STILL IN THE HOSPITAL, HAD ENDED UP DEVELOPING AN ABSCESS, AND RECEIVED A COLOSTOMY. THE PATIENT'S CONDITION WAS REPORTEDLY IMPROVING. ON (B)(64 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON INVOLVED WITH THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON DESCRIBED THE THERMAL BOWEL INJURY AS BEING 1 CM IN SIZE AND LOCATED IN THE SIGMOID COLON. ACCORDING TO THE SURGEON, NO INAPPROPRIATE CONTACT WITH ENERGIZED INSTRUMENTS WHILE ACTIVATED WAS OBSERVED DURING THE DA VINCI SURGICAL PROCEDURE. IN ADDITION, THE BOWEL INJURY WAS NOT SEEN OR NOTICED INTRA-OPERATIVELY. THE SURGEON DENIED THAT ANY EVIDENCE OF ARCING OF ELECTRICAL ENERGY FROM AN INSTRUMENT WAS OBSERVED DURING THE SURGICAL PROCEDURE. TEN DAYS POST-OPERATIVELY, THE PATIENT WAS READMITTED FOR COMPLAINTS OF PAIN AND A CT-SCAN WAS PERFORMED. THE PATIENT'S BOWEL INJURY WAS SURGICALLY REPAIRED. DETAILS OF THE SURGICAL REPAIR WERE 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: IT WAS REPORTED THAT DURING A DA VINCI RIGHT HEMICOLECTOMY PROCEDURE, AFTER THE PHYSICIAN'S ASSISTANT AT THE PATIENT SIDE CART INSTALLED AN ENDOWRIST INSTRUMENT, THE SURGEON WAS UNAWARE THAT HE HAD CONTROL OF THE INSTALLED INSTRUMENT AS HE WAS UNABLE TO VIEW THE INSTRUMENT THROUGH THE HIGH RESOLUTION STEREO VIEWER ON THE SURGEON SIDE CART BECAUSE THE ENDOSCOPE WAS NOT COMPLETELY INSERTED INTO THE PATIENT. AFTER THE SURGEON LOCATED THE INSTRUMENT, HE NOTED THAT HE HAD CREATED A SMALL INCISION. THE SURGEON REPAIRED THE DEFECT WITH SUTURES. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS PRESENT DURING SET-UP OF THE SYSTEM; HOWEVER, SHE DID NOT WITNESS THE INJURY TO THE PATIENT AS SHE LEFT THE OR. THE CSR INDICATED THAT UPON HER RETURN TO THE OPERATING ROOM, SHE OBSERVED THAT THE SURGEON WAS TRYING TO LOCATE THE TIPS OF THE INSTALLED INSTRUMENTS AND AFTER THE SURGEON LOCATED THE TIPS OF THE INSTRUMENTS SHE OVERHEARD THE SURGEON STATE THAT HE HAD CREATED A HOLE IN THE PATIENT'S DUODENUM. THE SURGEON USED THE DA VINCI SURGICAL SYSTEM TO REPAIR THE DEFECT USING SUTURES. THE CSR

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 4 HOURS POST A DA VINCI SINGLE SITE HYSTERECTOMY PROCEDURE, THE PATIENT REPORTED THAT SHE WAS NOT FEELING WELL AND PASSED OUT. A CT SCAN PERFORMED ON THE PATIENT SHOWED BLOOD IN HER ABDOMEN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND IT WAS DISCOVERED THAT THE PATIENT WAS BLEEDING FROM HER LEFT UTERINE ARTERY. REPORTEDLY, THE PATIENT'S BLEEDING WAS CONTROLLED AND THE PATIENT IS RECOVERING FINE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR HE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE AND THAT DURING THE SURGICAL PROCEDURE, HE DID NOT OBSERVE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE CSR INDICATED THAT TOWARDS THE END OF THE SURGICAL PROCEDURE, WHILE THE SURGEON WAS CLOSING THE PATIENT'S VAGINAL CUFF, INSUFFLATION WAS LOST. AT THAT TIME THE SURGEON MADE THE DECISION TO COMPLETE THE CLOSURE OF THE PATIENT'S VAGINAL CUFF VAGINALLY. THE LOSS OF INSUFFLATION WAS RELATED TO A THIRD PARTY DEVICE AND NOT TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. AT THE END OF THE PROCEDURE, THE SURGICAL A

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 POST A DA VINCI MYOMECTOMY PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT WAS RE-ADMITTED INTO THE HOSPITAL DUE TO DEEP VEIN THROMBOSIS (DVT) AND A PULMONARY EMBOLISM. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR SHE WAS NOT PRESENT DURING THE PATIENT'S ROBOTIC PROCEDURE; HOWEVER, ANOTHER ISI CSR WAS PRESENT AND ACCORDING TO THAT CSR, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE REPORTING CSR INDICATED THAT SHE SPOKE TO THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT'S DA VINCI MYOMECTOMY PROCEDURE WAS COMPLETED AND TOOK 3 HOURS. THE SURGEON STRUGGLED TO LOCATE THE PATIENT'S MYOMA DUE TO INACCURATE MRI RESULTS, CAUSING THE SURGEON TO CREATE THE HYSTEROTOMY IN AN AREA THAT WAS NOT IDEAL FOR ACCESSING THE PATIENT'S MYOMA, WHICH RESULTED IN A DELAY DURING THE SURGICAL PROCEDURE. THERE WAS A PROCTOR IN THE OR DURING THE SURGICAL PROCEDURE TO ASSIST WITH THE INTERPRETATION OF THE MRI. THE CSR WAS TOLD BY THE SURGEON THAT THE DA VINCI SURGICAL S

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)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED AN UF/IMPORTER REPORT (B)(4), WITH THE FOLLOWING EVENT DESCRIPTION: THE SURGEON ASKED FOR A UROLOGY CONSULT DUE TO A POSSIBLE THERMAL INJURY TO A URETER. A SECOND PHYSICIAN CAME IN AND CONFIRMED THERE WAS A URETERAL INJURY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE 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: IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE PATIENT SUSTAINED A COMMON BILE DUCT INJURY. NO OTHER INFORMATION REGARDING THE REPORTED EVENT 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: INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4), WITH THE FOLLOWING INFORMATION: DURING ROBOTIC LYMPH NODE DISSECTION, THE PHYSICIAN CUT THE LEFT URETER. THE UROLOGIST ON CALL FIXED THE URETER FOLLOWING ORIGINAL PROCEDURE ROBOTICALLY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON WAS DISSECTING THE GOOD PERITONEUM AND SKELETONIZING THE NODAL BUNDLE WHEN THE INJURY OCCURRED TO A PATIENT. IT IS UNKNOWN HOW LONG THE PROCEDURE WAS IN PROGRESS WHEN THE INJURY OCCURRED TO THE PATIENT. THE INITIAL REPORTER WAS UNABLE TO PROVIDE THE SURGEON'S BELIEF AS TO WHAT CAUSED OR CONTRIBUTED TO THE URETERAL INJURY. THE UROLOGIST USED 4 LATERAL STITCHES TO REPAIR THE INJURY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT HAS NOT RETURNED BACK TO THE HOSPITAL DUE TO THE REPORTED INJURY. THE INITIAL REPORTER WAS UNABLE TO PROVIDE ISI ANY FURTHER ADDITIONAL INFORMATION REGARDING THIS CASE.

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 POST A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED VAGINAL CUFF DEHISCENCE REQUIRING THE PATIENT TO UNDERGO AN ADDITIONAL SURGICAL PROCEDURE ON (B)(6) 2014 TO REPAIR HER VAGINAL CUFF. REPORTEDLY, REPAIR OF THE PATIENT'S VAGINAL CUFF WAS PERFORMED AT ANOTHER HOSPITAL. THE DATE OF THE DA VINCI HYSTERECTOMY PROCEDURE WAS NOT PROVIDED BY THE REPORTING HOSPITAL. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE AT THE HOSPITAL WHO REPORTED THIS INCIDENT TO ISI'S CLINICAL SALES REPRESENTATIVE (CSR). ACCORDING TO THE NURSE, THE PATIENT PRESENTED WITH SYMPTOMS OF VAGINAL CUFF DEHISCENCE AT THE HOSPITAL ON (B)(6) 2014. THE PATIENT'S VAGINAL CUFF WAS REPAIRED VAGINALLY. THE AFFECTED AREA WAS SUTURED. THE NURSE INDICATED THAT THE SURGEON WHO REPAIRED THE PATIENT'S VAGINAL CUFF DID NOT INDICATED WHAT CAUSED OR CONTRIBUTED TO THE ISSUE. THE NURSE DID NOT KNOW WHAT DATE THE PATIENT UNDERWENT THE DA VINCI SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. 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: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT'S BOWEL WAS PUNCTURED WHILE ADVANCING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INTO THE PATIENT. REPORTEDLY, THE AFFECTED AREA WAS REPAIRED. ON (B)(4) 2014 INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON THE PATIENT'S BOWEL WAS NOT PENETRATED; HOWEVER, THE SEROSA WAS DAMAGED. THE DEFECT WAS REPAIRED INTRA-OPERATIVELY WITH THE DA VINCI SURGICAL SYSTEM. THE AFFECTED AREA WAS SUTURED AND NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. THE SURGEON INDICATED THAT THE BEDSIDE ASSISTANT WAS PERFORMING ANOTHER TASK AND WAS NOT PAYING ATTENTION WHILE THE MCS INSTRUMENT WAS BEING ADVANCED INTO THE PATIENT, THUS CAUSING DAMAGE TO THE PATIENT'S SEROSA. ACCORDING TO THE SURGEON, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, MCS INSTRUMENT OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AND IT IS HIS BELIEF THAT THE DEFECT TO THE PATIENT'S SEROSA WAS USE ERROR RELATED. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT RECOVERED WELL. THE SURGEON ALSO INDICATED THAT ONE WEEK POST THE SURGICAL PROCEDU

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 A PATIENT HAD DIED AFTER UNDERGOING A DA VINCI LUNG LOBECTOMY PROCEDURE ON (B)(6) 2014. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS PRESENT DURING MOST OF THE DA VINCI PROCEDURE AND CLAIMS THAT THERE WAS NO REPORTED SYSTEM MALFUNCTION THAT OCCURRED DURING THE PROCEDURE. THE CSR WAS INFORMED ON (B)(4) 2014 BY THE SURGEON THAT THE PATIENT HAD DIED. THE SURGEON TOLD THE CSR THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE DA VINCI SYSTEM. PER THE CSR, THIS PATIENT HAD BEEN ALREADY TREATED WITH RADIOTHERAPY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED TO ISI ABOUT THIS CASE.

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 COMPLETION OF A DA VINCI MITRAL VALVE REPAIR WITH MAZE PROCEDURE, WHEN THE SURGEON WENT TO CLAMP THE PATIENT, HE OBSERVED THAT THE PATIENT HAD AN AORTIC DISSECTION. AS A RESULT THE SURGEON CONVERTED THE PROCEDURE TO AN OPEN STERNOTOMY. APPROXIMATELY 2 HOURS INTO THE OPEN PROCEDURE IT WAS DISCOVERED THAT THE PATIENT'S LEFT VENTRICLE WAS NOT FUNCTIONING AND AN ATTEMPT WAS MADE TO RESUSCITATE THE PATIENT'S LEFT VENTRICLE. REPORTEDLY, THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). APPROXIMATELY 2 DAYS LATER A CT SCAN PERFORMED ON THE PATIENT SHOWED THAT THE PATIENT HAD NO BRAIN ACTIVITY AND LATER THAT SAME DAY THE PATIENT EXPIRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS PRESENT DURING THE SURGICAL PROCEDURE. REPORTEDLY, THE PATIENT WAS NEVER TAKEN OFF BYPASS WHEN THE INCIDENT OCCURRED. ON (B)(4) 2014, THE CSR SPOKE TO THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT WAS DUE TO T

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 BENIGN HYSTERECTOMY PROCEDURE, THE PATIENT'S BLADDER WAS PERFORATED. REPORTEDLY, THE DAMAGE TO THE PATIENT'S BLADDER WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. THE PATIENT'S BLADDER WAS REPAIRED USING THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER THE SURGEON HAD DIFFICULTY DELINEATING THE PATIENT'S TISSUE PLANES AND WHILE ATTEMPTING TO PERFORM THE COLPOTOMY PORTION OF THE HYSTERECTOMY PROCEDURE USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE SURGEON INADVERTENTLY PERFORATED THE PATIENT'S BLADDER WHILE CAUTERY ENERGY WAS ACTIVATED. THE DAMAGE TO THE PATIENT'S BLADDER WAS IMMEDIATELY RECOGNIZED BY THE SURGEON, AS THE SURGEON OBSERVED THAT THE INSTALLED CATHETER WAS VISIBLE. THE SURGEON REPAIRED THE DEFECT TO THE PATIENT'S BLADDER LAPAROSCOPICALLY USING THE DA VINCI SURGICAL SYSTEM. THE AFFECTED AREA WAS SUTURED. AFTER THE 1ST REPAIR WAS COMPLETED, THE SURGEON OBSERVED LEAKAGE FROM THE REPAIRED AREA. THE SURGEON PERFORMED A 2ND REPAIR USING THE DA VINCI SURGI

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)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: I HAD MY PROSTATE REMOVED THE DA VINCI ROBOT AND DURING MY SURGERY, MY SURGEON ATTEMPTED TO FUSE TOGETHER SOME BLOOD VESSELS AND THE ROBOT FAILED TO FUSE SOME OF MY BLOOD VESSELS TOGETHER THUS CAUSING ME TO BLEED INTERNALLY. INSTEAD OF BEING IN THE HOSPITAL ONE NIGHT, I WAS IN THE HOSPITAL FOR OVER THIRTY DAYS. ALSO, ONE OF MY SURGEON'S INTERNS TOLD ME THAT WHEN MY SURGEON WAS ATTEMPTING TO REMOVE THE ROBOT FROM MY BODY THAT THE ROBOT STARTED UP ON ITS OWN AND DID CUT OTHER BLOOD VEINS. NO WHERE IN MY MEDICAL RECORDS WAS ANY OF WHAT HAPPENED TO ME WAS IN THE MEDICAL RECORDS THAT I OBTAINED FROM THE HOSPITAL. THE HOSPITAL HAD TO GIVE ME OVER 8 PINTS OF BLOOD AND I HAD TO STAY IN THE HOSPITAL FOR OVER 30 DAYS. THE OPERATION USING THE DA VINCI ROBOT ALMOST CAUSED ME THE LOSS OF MY LIFE AND I AM NOW BEING TREATED FOR SEVERE ANXIETY AND DEPRESSION OVER WHAT HAPPENED TO ME WHILE I WAS OPERATED ON VIA DA VINCI ROBOT. NONE OF WHAT I HAVE SAID WAS REPORTED ON ANY MEDICAL RECORDS THAT I PAID TO GET. MY SURGEON AND THE HOSPITAL COVERED UP WHAT ACTUALLY HAPPENED TO ME WHEN I HA

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 GASTROSTOMY PROCEDURE, APPROXIMATELY 1.5 DAYS AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL; THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND SUBSEQUENTLY EXPIRED. ON (B)(6) 2014, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT REPORTED THAT SHE WAS PRESENT AT THE BEGINNING OF THE PLANNED SURGICAL PROCEDURE. ACCORDING TO THE CSR SHE WAS TOLD BY THE SITE'S ROBOTICS COORDINATOR THAT THE PATIENT WAS VERY SICK PRIOR TO UNDERGOING THE ROBOTIC PROCEDURE AND THAT DURING THE SURGICAL PROCEDURE, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THE ROBOTICS COORDINATOR ALSO INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE PATIENT'S SPECIFIC PRE-EXISTING CONDITIONS WERE NOT PROVIDED TO THE CSR. 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT EXPIRED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE PATIENT HAD A HISTORY OF DRUG ABUSE, BLOOD PRESSURE ISSUES, AND WAS OBESE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER WAS NOT PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 1. THE PATIENT REPORTEDLY PASSED AWAY THE FOLLOWING DAY ON POST-OPERATIVE DAY 2. THE INITIAL REPORTER INDICATED THAT HE SPOKE TO THE SURGEON REGARDING THE REPORTED EVENT AND THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI HYSTERECTOMY PROCEDURE. ALSO, THERE WERE NO REPORTS THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED. ON (B)(6) 2014, THE INITIAL REPORTER SPOKE TO THE SURGEON AND WAS INFORMED THAT THE AUTOPSY REPORT WAS STILL NOT COMPLETED AT THE TIME. ON (B)(6) 2014, ISI CONTACTED THE SITE'S OR DIRECTOR. SHE STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROC

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 PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, A NURSE INJURED HER HAND WHILE ATTEMPTING TO MOVE THE PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PSC WAS ABOUT 1 INCH FROM THE WALL AND WAS IN NEUTRAL WHEN THE NURSE GRABBED THE HANDLE OF THE PSC IN AN AWKWARD POSITION. AT THAT SAME TIME, A SURGICAL TECHNICIAN SWITCHED THE PSC FROM NEUTRAL TO DRIVE. AT THAT POINT, THE PSC REPORTEDLY LURCHED BACKWARDS AND CRUSHED THE NURSE'S HAND BETWEEN THE PSC AND WALL. THE NURSE DID NOT BELIEVE THAT SHE ACTIVATED THE HAND CONTROL OF THE PSC. THE NURSE HAD TO GO TO THE EMERGENCY ROOM (ER) AND AN X-RAY WAS PERFORMED. NO BONE FRACTURES WERE FOUND. THE NURSE WAS FOUND TO HAVE SOFT TISSUE DAMAGE AND SWELLING. NO BRUISING WAS OBSERVED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER STATED FROM WHAT HE RECALLS, THE NURSE WAS GIVEN A BAG OF ICE FROM THE ER TO TREAT THE SWELLING. NO DRESSINGS OR BANDAGES WERE GIVEN TO TREAT THE NURSE. AT THIS TIME, THE INITIAL REPORTER STATED THAT THE NURSE IS BACK AT WORK AND IS DOING FINE. ON (B)(4) 2014, ISI ALSO CONTACTED THE FIELD SERVICE ENGINEER (FSE). ACC

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 COMPLETION OF A DA VINCI URETERAL REIMPLANTATION PROCEDURE, THE PATIENT DEVELOPED SEPSIS ROUGHLY AROUND POST-OPERATIVE DAY 2. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE SUSTAINED A PERFORATED COLON. THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2014. ACCORDING TO THE ROBOTICS COORDINATOR FROM THE SITE, AN INTERNAL INVESTIGATION WAS BEING PERFORMED IN RELATION TO THE REPORTED EVENT. THE CAUSE OF THE PATIENT'S BOWEL PERFORATION WAS UNKNOWN. HOWEVER, THE ROBOTICS COORDINATOR INDICATED THAT THE SITE BELIEVES THE BOWEL INJURY MIGHT HAVE OCCURRED DURING INTRODUCTION OF A CAMERA PORT. REPORTEDLY, THE CAMERA PORT WAS NOT CREATED UNDER DIRECT VISUALIZATION. ON (B)(6) 2014, ISI CONTACTED THE ROBOTICS COORDINATOR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. TO HER KNOWLEDGE, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. SHE REITERATED THAT THE SITE BELIEVES THE CAUSE OF THE PATIENT'S INJURY WAS DUE TO CAMERA TROCAR INSERTION.

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)(4) 2014, INTUITIVE SURGICAL INC. (ISI) REVIEWED A JOURNAL ARTICLE BY RUPA SEETHARAMAIAH ET AL. TITLED ROBOTIC REPAIR OF GIANT PARAESOPHAGEL HERNIAS. ACCORDING TO THE REPORTED ARTICLE, A (B)(6) HEALTHY WOMAN CAME TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. PEH WAS DIAGNOSED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. DURING THE PROCEDURE, A GPEH WAS FOUND AND THE STOMACH WAS STRONGLY ADHERED TO BOTH THE RIGHT AND LEFT CRUS. DURING THE DISSECTION, A PLEURAL INJURY WAS NOTICED. REDUCTION WAS COMPLETED, THE PLEURAL INJURY WAS REPAIRED WITH NO. 3-0 VICRYL (ETHICON), AND THE HERNIA WAS CLOSED WITH NONABSORBABLE SUTURE. NO PLEURAL TUBE WAS USED. A BIOLOGICAL MESH WAS PLACED AND A NISSEN FUNDOPLICATION PERFORMED. THE TOTAL PROCEDURE WAS COMPLETED IN 258 MINUTES, AND THE PATIENT WAS DISCHARGED 3 DAYS LATER. THE HOSPITAL NAME AND THE DA VINCI SERIAL NUMBER INVOLVED WITH THIS PATIENT WAS NOT PROVIDED IN THE ARTICLE.

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 NISSEN FUNDOPLICATION PROCEDURE, THE PATIENT'S STOMACH WAS PUNCTURED. THE SURGICAL PROCEDURE WAS COMPLETED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT UNDERWENT MULTIPLE PROCEDURES FOR REPAIR OF THE REPORTED INJURY.

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 PROSTATECTOMY PROCEDURE, THE SURGEON COULD NOT GET THE HARMONIC ACE CURVED SHEARS INSTRUMENT OR MARYLAND BIPOLAR FORCEPS INSTRUMENT TO ENERGIZE. DUE TO THE REPORTED ISSUE, THE INITIAL REPORTER INDICATED THAT THE PATIENT LOST 1300 CC OF BLOOD. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE ROBOTICS COORDINATOR, THE HOSPITAL HAD LOST POWER TO THE ENTIRE OR IN THE MORNING AND THE SURGICAL STAFF HAD UNPLUGGED AND RE-PLUGGED THE CABLES IN ORDER TO GET THEIR SYSTEMS ALL TURNED BACK ON FOR THE DA VINCI SURGICAL PROCEDURE. DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON ATTEMPTED TO ACTIVATE THE HARMONIC ACE CURVED SHEARS INSTRUMENT AND MARYLAND BIPOLAR FORCEPS INSTRUMENT BUT NOTICED THAT THEY WOULD NOT WORK. AFTER THE ROBOTICS COORDINATOR UNPLUGGED AND RE-PLUGGED THE INSTRUMENT CABLES LEADING TO THE ELECTROSURGICAL UNIT (ESU), THE INSTRUMENTS BEGAN TO WORK PROPERLY FOR THE REST OF THE PROCEDURE. LATER THAT SAME DAY, THE FSE PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE CHECKED THE SENSOR STATUS FOR FOOT PEDAL ACTIVATION ON THE SYSTEM WHICH PASSED. THE

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 PROSTATECTOMY ON AN UNSPECIFIED DATE. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY MEDICAL RECORDS. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT HAD PROSTATE SURGERY. DURING SURGERY, THE MACHINE BROKE DOWN. HE SPENT 12 DAYS IN THE HOSPITAL. IN ADDITION, THE LEGAL DOCUMENT NOTED THE PATIENT INJURY AS COMPARTMENT SYNDROME.

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 COMPLETION OF A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT EXPIRED ON POST-OPERATIVE DAY 2. NO ISSUES WERE REPORTED TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER REVIEWED THE PATIENT'S MEDICAL RECORDS AND THE OPERATIVE REPORT. ACCORDING TO THE RISK MANAGER, THE PATIENT HAD A HISTORY OF CARDIAC DISEASE AND CORONARY ARTERY DISEASE. HE WAS A 2 PACK/DAY SMOKER. ON (B)(6) 2014, THE PATIENT WAS SEEN IN THE HOSPITAL FOR COMPLAINTS OF ABDOMINAL PAIN AND CHEST PAIN. IMAGING WAS PERFORMED AND IT WAS DETERMINED AT THE TIME THAT THE PATIENT NEEDED A CHOLECYSTECTOMY. THE PATIENT REPORTEDLY TOLD THE SURGEON THAT HE HAD KNOWN THAT HE HAD GALL STONES FOR 3 YEARS. BASED ON THE OPERATIVE REPORT, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY. THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON POST-OPERATIVE DAY 1 ((B)(6) 2014). THE RISK MANAGER INDICATED THAT AT THE TIME OF DISCHARGE, THE PA

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)(4) 2014, INTUITIVE SURGICAL INC. (ISI) REVIEWED A JOURNAL ARTICLE BY TAKAHRIO YASUI ET AL TITLED, IMPACT OF PROSTATE WEIGHT ON PERIOPERATIVE OUTCOMES OF ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY WITH A POSTERIOR APPROACH TO THE SEMINAL VESICLE. ACCORDING TO THE REPORTED ARTICLE, FIVE PATIENTS EXPERIENCED INTRAOPERATIVE COMPLICATIONS, INCLUDING 3 PATIENTS WITH POSTERIOR BLADDER INJURY, 1 PATIENT WITH RECTAL INJURY, AND 1 PATIENT WITH ILEUM INJURY. IN ALL THESE PATIENTS, THE INJURY WAS REPAIRED DURING A ROBOTIC OPERATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENTS. THE HOSPITALS NAME, DA VINCI SYSTEM SERIAL NUMBERS AND TYPE OF PROCEDURES INVOLVED WITH ALL FIVE COMPLAINTS WERE NOT INCLUDED IN THIS ARTICLE.

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 AFTER COMPLETION OF A DA VINCI SIGMOID COLECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ANASTOMOTIC LEAK. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON BELIEVES THE INFERIOR MESENTERIC ARTERY (IMA) WAS NOT FULLY SEALED DURING THE SURGICAL PROCEDURE AND THEREFORE A LEAK OCCURRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SIGMOID COLECTOMY PROCEDURE. HE DID NOT OBSERVE ANY ISSUES WITH THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER ALSO STATED THAT HE DID NOT WITNESS ANY INTRA-OPERATIVE COMPLICATIONS OTHER THAN SLIGHT BLEEDING THAT THE SURGEON WAS ABLE TO CONTROL AND SEAL WITHOUT ANY ISSUES. THE INITIAL REPORTER DID NOT KNOW THE CURRENT STATUS OF THE PATIENT. ON (B)(4) 2014, ISI ALSO CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI SIGMOID COLECTOMY PROCEDURE. THE SURGEON INDICATED THAT POST-OPERATIVELY, THE PATIENT DEVELOPED A LARGE HEMATOMA IN THE MESENTERY THAT REQUIRED SURGICAL INTERVENTION FOR CLOT EVACUATION. THE SUR

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 ENDOMETRIOSIS RESECTION PROCEDURE, PATIENT SIDE MANIPULATOR 3 (PSM3) HAD UNINTENDED MOVEMENT AND THE PATIENT WAS FOUND TO HAVE SUSTAINED TWO 1 PUNCTURE WOUNDS TO THE SIGMOID COLON. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON STATED THAT THE CLUTCH BUTTON FROM PSM3 HAD BEEN PUSHED TO MOVE THE INSTRUMENT TO THE END OF THE CANNULA TIP. AT THE TIME OF THE EVENT, IT IS UNCLEAR WHAT INSTRUMENT WAS INSTALLED ON PSM3. AT AN UNSPECIFIED TIME DURING THE SURGICAL PROCEDURE, THE SURGEON STATED THAT PSM3 WENT SPASTIC. THE SURGEON THEN REMOVED THE INSTRUMENT INSTALLED ON PSM3 AND FOUND TWO PUNCTURE WOUNDS TO THE SIGMOID COLON. THE SURGEON REPAIRED THE PUNCTURE WOUNDS AND INDICATED THAT THE PATIENT WAS DOING WELL. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE TEST DROVE THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. HE WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH PSM3. ON (B)(4) 2014, ISI CONTACT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE DEATHS. THESE ALLEGATIONS WERE FIRST RECEIVED BY INTUITIVE SURGICAL DURING THE TIME PERIOD OF (B)(4) 2013 TO (B)(4) 2014. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2004 THROUGH (B)(6) 2014.

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 GASTRECTOMY SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE HARMONIC ACE INSERT WAS SUDDENLY BROKEN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER TO ASK FOR ADDITIONAL INFORMATION, THE CUSTOMER INDICATED THAT A FRAGMENT FELL INTO THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. AN X-RAY WAS PERFORMED AND NO FRAGMENTS WERE SEEN TO REMAIN IN THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE ON AN UNSPECIFIED DATE IN 2010. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT MEDICAL RECORDS. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. PER THE LEGAL DOCUMENT, THE PATIENT SUFFERED INTERNAL BLEEDING DURING SURGERY. PATIENT WAS IN A COMA FOR 2 WEEKS AND THEN DIED.

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 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. THE DA VINCI SERIAL OR MODEL IS UNKNOWN. IN (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI ROBOTIC-ASSISTED PROSTATECTOMY FOR UNKNOWN REASON. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: PER ROBOTIC SURGERY CLAIM FORM, THE PATIENT HAD SURGERY IN (B)(6) 2012 AND PASSED AWAY (B)(6) 2012. HE SUSTAINED A STROKE AND KNICKED BLADDER. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION.

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2011 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2011. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ACCORDING TO THE MEDIATION COVER SHEET, ON (B)(6) 2011, THE PATIENT HAD A PROSTATECTOMY PROCEDURE. THE PATIENT'S ABDOMEN BECAME DISTENDED; CT REVEALED URINE POOLING IN ABDOMEN; ER SURGERY TO REPAIR TORN BLADDER; PASSED AWAY AFTER COMPLICATIONS FROM SUBSEQUENT SURGERY ON (B)(6) 2011.