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 HYSTERECTOMY PROCEDURE, THE PATIENT CODED DURING VAGINAL CUFF CLOSURE. AT THE TIME THE PATIENT CODED, THE INITIAL REPORTER INDICATED THAT THE DA VINCI S SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF WAS UNABLE TO REVIVE THE PATIENT WHO SUBSEQUENTLY PASSED AWAY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED FDA VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: UNDERWENT ROBOTIC -DA VINCI- PROCTECTOMY. RECTUM WAS PERFORATED AND NOT DETECTED UNTIL SEPSIS INFECTION HAD DEVELOPED REQUIRING EXTENDED HOSPITAL STAY AND NUMEROUS SURGERIES TO CLEAN OUT THE INFECTION AND PERFORM A COLOSTOMY.

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 A DA VINCI SI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A URETERAL INJURY. NO ADDITIONAL 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND/OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY. THE DATE OF THE PROCEDURE IS UNKNOWN. 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 TO HER COLON AND DAMAGES THEREFROM.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL DUE TO A BOWEL PERFORATION. IT IS UNKNOWN AT THIS TIME WHEN THE BOWEL PERFORATION WAS NOTICED. THE PATIENT WAS RECOVERING AT THE HOSPITAL AND IT IS UNKNOWN WHETHER THE PATIENT HAD ANY OTHER COMPLAINTS. THE SURGEON MENTIONED TO THE CLINICAL SALES REPRESENTATIVE (CSR) THAT THE PROBLEM WAS DUE TO THE ASSISTANT. THE CSR DOES NOT HAVE ANY FURTHER CLINICAL INFORMATION AS HE WAS NOT AT THE SITE DURING THE DA VINCI HYSTERECTOMY PROCEDURE. INTUITIVE SURGICAL INC. (ISI) ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT; HOWEVER, HAS BEEN UNSUCCESSFUL IN GETTING A HOLD OF THE SURGEON. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT IS BEING REPORTED, SINCE THE PATIENT HAD SUFFERED A BOWEL PERFORATION AFTER UNDERGOING A DA VINCI HYSTERECTOMY 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 SI OVARIAN CYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED A SEROSAL TEAR TO THE BOWEL THAT WAS NOTICED AFTER INSUFFLATION WAS LOST. THE INJURY WAS REPAIRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE EVENT OCCURRED TOWARDS THE END OF THE DA VINCI SI SURGICAL PROCEDURE. AT THE TIME THE EVENT OCCURRED, PNEUMOPERITONEUM WAS LOST FROM TUBING PLACED THROUGH A LAPAROSCOPIC ASSIST PORT. DUE TO LOSS OF INSUFFLATION, THE SURGICAL STAFF LOST VISION OF THE OPERATIVE FIELD. AFTER INSUFFLATION WAS LOST, A SEROSAL TEAR WAS NOTICED ON THE PATIENT'S BOWEL. ALTHOUGH THE BOWEL WAS NOT PERFORATED, A GYN SURGEON MADE THE DECISION TO APPLY SUTURES TO THE BOWEL INJURY AS A PRECAUTION. THE CSR STATED THAT THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF POST-OPERATIVE COMPLICATIONS. THE CSR STATED THAT NO MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL BENIGN HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES. STATES PATIENT WAS MADE AWARE THAT HIS INJURIES MAY BE THE RESULT OF THE DA VINCI ON (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 DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE PATIENT SUSTAINED A POSSIBLE INJURY OF THE INFERIOR EPIGASTRIC ARTERY UPON ENTRY OF A TROCAR. THE CLINICAL COORDINATOR INDICATED THAT THE PATIENT HAD EXCESSIVE BLEEDING AND WAS REFERRED TO A TRAUMA SURGEON ON POST-OP DAY 2. ACCORDING TO THE CLINICAL COORDINATOR, THE ARTERIAL INJURY WAS DISCOVERED DURING EXPLORATORY SURGERY. ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CLINICAL COORDINATOR. SHE WAS NOT PRESENT DURING THE REPORTED EVENT. SHE DID NOT KNOW WHO THE MANUFACTURER WAS OF THE TROCAR INVOLVED WITH THE EVENT. SHE ALSO DID NOT KNOW IF THE TROCAR ENTRY WAS RELATED TO A ROBOTIC PORT OR A LAPAROSCOPIC ASSIST PORT. THE CLINICAL COORDINATOR STATED THAT THE PATIENT WAS CURRENTLY STABLE AND HAS SINCE BEEN DISCHARGED HOME AFTER THE EVENT OCCURRED. NO ADDITIONAL 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 SI ATRIAL APPENDAGE LIGATION PROCEDURE, THE SURGEON INADVERTENTLY CUT THE ATRIAL ARTERY DUE TO IMPROPER ANATOMY IDENTIFICATION AND THE PATIENT SUBSEQUENTLY PASSED AWAY. THE OR DIRECTOR FROM THE SITE INDICATED THAT ADHESIONS AND HEART ANATOMY ALTERED DUE TO PREVIOUS SURGERY LEAD TO IMPROPER IDENTIFICATION OF ANATOMY. THE OR DIRECTOR STATED THE DA VINCI SYSTEM DID NOT CONTRIBUTE TO THE PATIENT OUTCOME. THE CLINICAL SALES REPRESENTATIVE (CSR) INDICATED THAT THE PATIENT HAD PREVIOUS HEART SURGERY AND THE LEFT ATRIAL ARTERY WAS REROUTED IN AN IMPROPER POSITION THAT THE SURGEON WAS NOT AWARE OF. THE CSR ALSO INDICATED THAT THE PATIENT HAD ADHESIONS THAT CONTRIBUTED TO IMPROPER ANATOMY IDENTIFICATION. AFTER THE ATRIAL ARTERY WAS INADVERTENTLY CUT, THE SURGEON MADE THE DECISION TO OPEN THE PATIENT UP AND ATTEMPT TO STOP THE BLEEDING. THE CSR INDICATED THAT THE PATIENT DID NOT SURVIVE THE SURGERY. ACCORDING TO THE CSR, THE SURGEON INDICATED THAT THE DA VINCI SYSTEM DID NOT MALFUNCTION DURING THE SURGICAL PROCEDURE AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY. THE PATIENT UNDERWENT REPAIR OF THE BOWEL INJURY BY GENERAL SURGERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGER (RM) FROM THE SITE. THE RM REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY DOCUMENTATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THERE ALSO WAS NO REPORT THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED DURING THE PROCEDURE. BASED ON THE RM'S REVIEW OF THE PATIENT'S MEDICAL RECORDS, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013 WITH REPORTED COMPLAINTS OF ABDOMINAL PAIN. ON (B)(6) 2013, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY TO EVALUATE A SUSPECTED PELVIC ABSCESS. THE FOLLOWING DAY ON (B)(6) 2013, THE PATIENT UNDERWENT REPAIR OF A PERFORATED BOWEL. ALSO, ON (B)(6) 2013, THE PATIENT UNDERWENT A SMALL BOWEL RESECTION PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITH A COLOSTOMY ON (B)(6) 2013. DURING THE COURSE OF THE HOSPITALIZATION, THE PATIENT WAS REPORTEDLY TREATED FOR SEPS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, THE INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REP (CSR) REPORTED A NEEDLE DROPPING INTO A PATIENT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2013. THE CSR REPORTED A LARGE NEEDLE DRIVER INSTRUMENT THAT WAS INSTALLED ON THE PATIENT SIDE MANIPULATOR 2 (PSM2) INADVERTENTLY OPENED AND THE NEEDLE HAD DROPPED INTO THE PATIENT. THE SITE RESEATED THE INSTRUMENT AND WAS ABLE TO OPERATE NORMAL. A C-ARM WAS USED; HOWEVER, THE SITE WAS UNABLE TO LOCATE THE NEEDLE. INFORMATION DETAILING THE EVENTS LEADING TO THE ALLEGED INADVERTENT DROP WAS NOT REPORTED AT THE TIME. ON (B)(6) 2013, ISI SPOKE WITH THE ISI CSR, WHO WAS THE INITIAL REPORTER. HE CONFIRMED WITH THE SURGEON THAT THE DROPPED NEEDLE HAS NOT BEEN RETRIEVED; HOWEVER, HE IS NOT AWARE OF THE PATIENT SUSTAINING ANY POST-OPERATIVE COMPLICATIONS. HE WAS UNABLE TO INDICATE HOW LONG THE INSTRUMENT WAS IN USE BEFORE THE NEEDLE DROPPED OUT OF THE INSTRUMENT. HE ALSO INDICATED THAT THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT WITH NO ISSUES AFTER IT WAS RESEATED IN THE PSM2. THE SCRUB TECH ALSO INSPECTED THE INSTRUMENT AFTER THE PROCEDURE AND IT APPEARED FINE. HE WAS UNABLE TO PROVIDE THE LOT NUMBER O

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED A PATIENT INJURY THAT INCURRED DURING A DA VINCI SI HYSTERECTOMY PROCEDURE. ABOUT 4 HOURS INTO THE DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED BLOOD COMING OUT OF THE PATIENT'S EXTERNAL ILIAC VEIN. IT WAS ESTIMATED TO BE ABOUT A 5MM INJURY. PRESSURE WAS PUT ON THE INJURED VEIN AND THE SURGICAL STAFF CALLED THE VASCULAR SURGEON. WHEN THE VASCULAR SURGEON GOT TO THE OPERATING ROOM, THE INJURED VEIN HAD CLOTTED AND STOPPED BLEEDING. INFORMATION DETAILING THE EVENTS LEADING TO THE PATIENT'S VEIN INJURY WERE NOT PROVIDED. NO OTHER COMPLICATIONS WERE REPORTED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO CONTACT THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

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) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: WHILE PERFORMING THE LAPAROSCOPIC ROBOTIC ASSISTED SACROCOLPOPEXY, THE SURGICAL TEAM NOTICED TWO HOLES IN THE BLADDER. IMMEDIATE REPAIR WAS PERFORMED PER PHYSICIAN.

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 HYSTERECTOMY PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. AFTER BEING RELEASED FROM THE HOSPITAL ON AN UNSPECIFIED DATE, THE PATIENT INDICATED THAT SHE EXPERIENCED PAIN, DISCOMFORT, A BLADDER INFECTION, AND FLUID DISCHARGE. ON (B)(6) 2013, THE PATIENT CLAIMED THAT HER INCISION BURST AND HER BOWEL CAME OUT. THE PATIENT WAS REPORTEDLY RUSHED TO AN EMERGENCY ROOM (ER) AND REPAIR OF THE POST-OPERATIVE COMPLICATIONS WAS PERFORMED. THE DA VINCI SURGICAL SYSTEM WAS NOT USED DURING REPAIR OF THE POST-OPERATIVE COMPLICATIONS. THE PATIENT DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION ABOUT A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL BECAUSE FECAL MATTER WAS FOUND IN HER VAGINAL CANAL. THE PATIENT UNDERWENT A SMALL BOWEL REPAIR AND CURRENTLY HAS A COLOSTOMY. THE SITE REPORTED THERE WAS POSSIBLE UNINTENDED ARCING. NO OTHER DETAILS WERE PROVIDED AT THIS TIME. ON (B)(6) 2013, ISI SPOKE WITH ONE OF THE SITE'S CONTACTS AND OBTAINED ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2013, WHICH WAS 2 DAYS AFTER THE DA VINCI HYSTERECTOMY PROCEDURE. HE WAS UNABLE TO PROVIDE ANY DETAILS REGARDING THE PATIENT'S CONDITION BEFORE THE RE-ADMISSION. HE STATED THAT THE GENERAL SURGEON WHO PERFORMED THE SMALL BOWEL REPAIR BELIEVES THAT THE INJURY WAS ATTRIBUTED TO PULL AND TUG ISSUES AND NOT DUE TO A THERMAL INJURY. HE WAS UNABLE TO CONFIRM OR DENY IF THERE WERE ANY MALFUNCTIONS OF THE DA VINCI SYSTEM, INSTRUMENTS, AND OR ACCESSORIES THAT COULD HAVE CONTRIBUTED TO THE PATIENT'S INJURIES AND ADVISED ISI TO CONTACT THE ROBOTICS COORDINATOR, WHO WAS CURRENTLY OUT OF THE OFFICE, FOR MORE INFORMATION. ISI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: DURING A ROBOTIC ASSISTED HYSTERECTOMY, A HOLE WAS NOTED IN THE BLADDER. THE BLADDER WAS REPAIRED AND A CYSTOSCOPY PERFORMED BY THE PHYSICIAN.

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 SI LOBECTOMY PROCEDURE, THE SURGEON TORE THE PATIENT'S PULMONARY VEIN. THE INITIAL REPORTER INDICATED THAT WHILE THE SURGEON WAS USING A CADIERE FORCEPS INSTRUMENT AND A MARYLAND BIPOLAR FORCEPS INSTRUMENT, THE PATIENT'S PULMONARY VEIN WAS TORN. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT RECEIVED 20 UNITS OF BLOOD AND LEFT SURGERY IN STABLE CONDITION.

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 SI SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT PASSED AWAY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INFORMED HIM THAT THE PATIENT PASSED AWAY AFTER A SUCCESSFUL GASTRIC SLEEVE PROCEDURE. IN ADDITION, THE SURGEON STATED THAT THE PATIENT'S AUTOPSY DID NOT FIND ANY SURGICAL ISSUES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT HAD A ROBOTIC COLPOSUSPENSION WITH MESH AND A BILATERAL SALPINGO-OOPHORECTOMY (S&O). SEVERAL DAYS POST OP SHE DEVELOPED POST OPERATIVE PAIN, NAUSEA AND VOMITING. GENERAL SURGERY WAS CONSULTED. AFTER SOME TESTS WERE DONE THE PATIENT WAS TAKEN BACK TO THE OR FOR AN EXPLORATORY LAPAROTOMY. A SMALL BOWEL IATROGENIC INJURY WAS FOUND AND REPAIRED. THE PATIENT TOLERATED THE PROCEDURE WELL.

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) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: EVENT DESC: THE PATIENT HAD A ROBOTIC COLPOSUSPENSION WITH MESH AND A BILATERAL SALPINGO-OOPHORECTOMY (S&O). SEVERAL DAYS POST OP SHE DEVELOPED POST OPERATIVE PAIN, NAUSEA AND VOMITING. GENERAL SURGERY WAS CONSULTED. AFTER SOME TESTS WERE DONE THE PATIENT WAS TAKEN BACK TO THE OR FOR AN EXPLORATORY LAPAROTOMY. A SMALL BOWEL IATROGENIC INJURY WAS FOUND AND REPAIRED. THE PATIENT TOLERATED THE PROCEDURE WELL.

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 RADICAL CYSTECTOMY WITH ILEAL LOOP DIVERSION AND RADICAL PROSTATECTOMY WITH BILATERAL EXTENDED PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2013. AT THE TIME, THE PATIENT WAS SUFFERING FROM PAPILLARY UROTHELIAL CARCINOMA, HIGH GRADE, OF THE BLADDER. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES THAT CAUSED HIM TO UNDERGO ADDITIONAL SURGERIES. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE PLAINTIFF'S ATTORNEY, AROUND POST-OPERATIVE DAY 4, THE PATIENT BEGAN EXPERIENCING COMPLICATIONS HIGHLY INDICATIVE OF POSSIBLE BOWEL PERFORATION AND LEAK, WHICH SIGNS AND SYMPTOMS WERE NOT PROPERLY RECOGNIZED AND ADDRESSED UNTIL POST-OPERATIVE DAY FOURTEEN (14). AS A RESULT, THE PATIENT ALLEGEDLY DEVELOPED AN INTRA-ABDOMINAL ABSCESS AND SEPTIC SHOCK, AND ULTIMATELY PASSED AWAY ON (B)(6) 2013.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI SUPRAGLOTTIC RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, A PATIENT SUBSEQUENTLY EXPIRED 2 DAYS LATER ON (B)(6) 2013. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO COMPLICATIONS DURING THE DA VINCI SI SURGICAL PROCEDURE AND THE PATIENT HAD BEEN TAKEN TO THE ICU FOR RECOVERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'POSSIBLE BURN OR CUT IN INTESTINES OR LINING OF HER STOMACH, INCISION WAS INFECTED AND SHE CONTRACTED E COLI AFTER THE SURGERY. COULDN'T URINATE FOR ABOUT THREE MONTHS.'

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 SI HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A BOWEL PERFORATION AND REPORTED COMPLAINTS OF SEVERE PAIN ON POST-OP DAY 1. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT WAS FOUND TO BE SEPTIC. ON POST-OP DAY 3, AN OPERATION WAS PERFORMED TO REMOVE NECROTIC BOWEL. THE PATIENT SUBSEQUENTLY 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 AFTER COMPLETION OF A DA VINCI SI SIGMOID COLECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, A PATIENT SUBSEQUENTLY EXPIRED 7 DAYS LATER ON (B)(6)2013. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON PERFORMED AN ANASTOMOSIS DURING THE SURGICAL PROCEDURE AND A LEAK WAS FOUND AFTER A LEAK TEST WAS DONE. AFTER THE SURGEON REPAIRED THE LEAK BY APPLYING SUTURES, ANOTHER LEAK TEST WAS PERFORMED AND NO FURTHER COMPLICATIONS WERE FOUND. THE SURGICAL PROCEDURE WAS COMPLETED. THE DAY AFTER SURGERY, THE PATIENT WAS REPORTEDLY DOING FINE. HOWEVER, OVER THE FOLLOWING WEEKEND, THE PATIENT WAS NOT DOING WELL. ACCORDING TO THE INITIAL REPORTER, A CT SCAN WAS PERFORMED ON THE PATIENT ON (B)(6) 2013, AND NO ISSUES WERE SEEN. THE INITIAL REPORTER INDICATED, HOWEVER, THAT AN ANASTOMOSIS DYE TEST WITH X-RAY WAS PERFORMED AND A LEAK WAS SEEN. THE PATIENT WAS RUSHED TO SURGERY AND THE PATIENT EXPIRED IN THE OPERATING ROOM (OR).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2010, AND ALLEGED TO HAVE INJURIES INCLUDING BOWEL OBSTRUCTION AND ABDOMINAL PAIN. IT WAS ALSO ALLEGED THAT THE PATIENT'S LARGE INTESTINE AND COLON WERE REMOVED DUE TO INVOLUNTARY ACCIDENTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SEPSIS ON (B)(6) 2013. ACCORDING TO THE INITIAL REPORTER, A PHYSICIAN'S ASSISTANT, THE SURGEON PERFORMED LYSIS OF ADHESIONS WITH LAPAROSCOPIC EQUIPMENT BEFORE COMPLETING THE DA VINCI SI CHOLECYSTECTOMY PROCEDURE. ON (B)(6) 2013, THE INITIAL REPORTER CHECKED ON THE STATUS OF THE PATIENT AND DISCOVERED THAT THE PATIENT HAD SEPSIS. THE PATIENT SUBSEQUENTLY UNDERWENT OPEN SURGERY ON AN UNSPECIFIED DATE AND TWO ENTEROTOMIES IN THE BOWEL WERE FOUND. THE INITIAL REPORTER INDICATED THAT THE SURGEON WAS NOT SURE HOW THE INJURIES OCCURRED. ACCORDING TO THE INITIAL REPORTER, THE SURGEON SPECULATED THAT THE INJURIES POSSIBLY OCCURRED DURING LYSIS OF THE ADHESIONS OR DURING PLACEMENT OF PORTS. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS ON A VENTILATOR AND HAD DEVELOPED RENAL FAILURE.

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 A PATIENT ALLEGEDLY SUSTAINED A PERFORATED COLON WHILE UNDERGOING TREATMENT FOR CARCINOID TUMORS USING THE DA VINCI SURGICAL SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE TITLED, PERIOPERATIVE OUTCOMES OF ROBOTIC VERSUS LAPAROSCOPIC HYSTERECTOMY FOR BENIGN DISEASE. WITHIN THE ARTICLE, THE FOLLOWING STATEMENT WAS DOCUMENTED, ONE PATIENT WHO UNDERWENT ROBOTIC HYSTERECTOMY SUSTAINED A COMBINED BLADDER AND BOWEL INJURY DIAGNOSED 14 DAYS POSTOPERATIVELY AFTER PRESENTING WITH FEVER AND PELVIC ABSCESS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVED REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN JULY 3, 2018 - OCTOBER 2, 2018. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM AUGUST 2013 - MAY 2018.

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 MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE. PER THE RECORDS, AT THE TIME OF SURGERY, SHE WAS NOTED TO HAVE ADHESIONS OF HER SMALL AND LARGE INTESTINES, WHICH WERE TAKEN DOWN WITH METICULOUS SHARP DISSECTION. POST OPERATIVELY THE PATIENT DEVELOPED A FEVER. ON (B)(6) 2010, THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY WHICH REPORTEDLY SHOWED A PERFORATION OF THE DISTAL ILEUM AND ADHESIONS. THE PATIENT UNDERWENT LAPAROTOMY THROUGH A MIDLINE ABDOMINAL INCISION AND THE PERFORATION IN THE SMALL BOWEL WAS REPAIRED. SECONDARY TO ADHESIONS OF THE ILEUM TO THE RIGHT OVARY AND TUBE, THE DECISION WAS MADE TO REMOVE THE RIGHT OVARY AND TUBE AND A PORTION OF THE ILEUM WAS REMOVED, AND AN ANASTOMOSIS WAS CREATED. SHE DISCHARGED HOME ON (B)(6) 2010. PER THE DOCUMENTATION PROVIDED THE PATIENT HAD URINARY RETENTION REQUIRING INTERMITTENT SELF CATHETERIZATION. ON (B)(6) 2010, SHE UNDERWENT CYSTOSCOPY WHICH SHOED THE RIGHT URETERAL ORIFICE AND TUNNEL WERE SOMEWHAT ELEVATED AND SWOLLEN. NO INDIGO CARMINE DYE COULD BE SEEN COMING FROM

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 MEDIATION EFFORT, ON JULY 25, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE IN (B)(6) 2008. THE DOCUMENTATION PROVIDED ALLEGED THAT THE PATIENT'S VAGINAL WALL WAS BURNED DURING HER HYSTERECTOMY AND SHE SUFFERED A RECTAL-VAGINAL FISTULA RESULTING IN A COLOSTOMY, MULTIPLE CT SCANS, SEVERAL OUTPATIENT SURGERIES AND PROCEDURES AND 2 ADDITIONAL MAJOR SURGERIES WITH HOSPITAL STAYS. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT HAD A FIBROID GROWTH ON HER UTERUS FOR MANY YEARS AND HAD FOR SOME TIME BEEN EXPERIENCING INCREASING ABDOMINAL PAIN. THE PATIENT CLAIMED THAT AS A RESULT OF THE BURN TO HER VAGINAL WALL, SHE DEVELOPED A VAGINAL-RECTAL FISTULA AND STOOL WAS COMING OUT OF HER VAGINA. THE DOCUMENTATION STATES THAT THE PATIENT HAD A COLOSTOMY PERFORMED ON AN UNSPECIFIED DATE FOLLOWED BY AN ATTEMPT TO REPAIR THE FISTULA. IN ADDITION, THE PATIENT REPORTEDLY DEVELOPED ABDOMINAL PAIN AND BLOATING FROM THE PROCEDURES AND MEDICATIONS, WHICH CAUSED HER TO SPEND A DAY IN THE ER. THIS SURGERY WAS PERFORMED IN (B)(6) 2008. ACCORDING TO THE ALLEGATIONS, DURING HER STAY IN

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 NEPHRECTOMY PROCEDURE, THE INITIAL REPORTER, A ROBOTICS COORDINATOR, INDICATED THAT THE ILLUMINATOR LOST POWER AND WENT OUT ON THE VISION SIDE CART (VSC). AFTER THE ILLUMINATOR LOST POWER, A SURGICAL STAFF MEMBER DROPPED A NEEDLE USED FOR SUTURING WHILE ATTEMPTING TO REMOVE THE NEEDLE THROUGH A LAPAROSCOPIC ASSIST PORT. THROUGH TROUBLESHOOTING, THE ROBOTICS COORDINATOR REBOOTED THE VSC AND ILLUMINATOR. THE ROBOTICS COORDINATOR ALSO REPLACED THE POWER CORD AND TRIED A DIFFERENT ELECTRICAL OUTLET. HOWEVER, THE VISION ISSUE PERSISTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AFTER THE ROBOTICS COORDINATOR IMPLEMENTED AN EXTERNAL LIGHT SOURCE. AFTER COMPLETION OF THE SURGICAL PROCEDURE, AN X-RAY WAS PERFORMED TO ASSIST WITH SEARCHING FOR THE DROPPED NEEDLE. ON (B)(4) 2013, AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REPAIRED THE SYSTEM BY REPLACING THE ILLUMINATOR.

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 PROSTATECTOMY PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A RECTAL PERFORATION. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION: THE DA VINCI PROSTATECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2013. IT IS UNKNOWN IF THE SURGICAL PROCEDURE WAS RECORDED. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS DURING THE SURGICAL PROCEDURE. THE SURGEON BELIEVED THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. TEN DAYS LATER ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH SYMPTOMS OF URINARY AND FECAL INCONTINENCE. ON (B)(6) 2013, THE PATIENT HAD A FOLLOW-UP VISIT AT THE HOSPITAL AND HAD COMPLAINTS OF INCONTINENCE AND LEAKAGE OF URINE FROM THE URETHRA. THE PATIENT DID NOT RECEIVE ANY TREATMENT DURING THE FOLLOW-UP VISIT. ON (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH A RECTAL PERFORATION. HOWEVER, THE PATIENT DID NOT RECEIVE ANY IMMEDIATE TREATMENT UPON BEING DIAGNOSED WITH THE REC

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 SI LOW ANTERIOR RESECTION PROCEDURE, WHILE THE SURGEON WAS PERFORMING DISSECTION AND MOBILIZING, THE PATIENT'S ILIAC VESSEL WAS NICKED, CAUSING THE PATIENT TO LOSE BLOOD. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES TO CONTROL THE PATIENT'S BLEEDING. REPORTEDLY, NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES 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: ON 09/06/2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LETTER FROM AN ATTORNEY SEEKING INFORMATION RELATED TO A DA VINCI SYSTEM. IT WAS REPORTED IN THE LETTER THAT A PATIENT HAD DIED FOLLOWING VASCULAR DAMAGE THAT WAS INCURRED AT THE TIME OF INITIATING A DA VINCI ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2013. ON (B)(4) 2013, ISI SPOKE WITH THE ATTORNEY REPRESENTING THE HOSPITAL. SHE CONFIRMED THAT THE DA VINCI SYSTEM WAS NEVER USED DURING THE PROCEDURE. SHE COULD NOT PROVIDE THE CAUSE OF DEATH AS THE RESULTS OF THE AUTOPSY ARE STILL PENDING. THE PATIENT'S INJURY WAS NOTICED UPON INSERTION OF THE CAMERA SCOPE INTO THE FIRST NON-ISI TROCAR THAT WAS INSERTED. THE PATIENT'S HYSTERECTOMY PROCEDURE WAS PLANNED TO BE A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY; HOWEVER, THE PATIENT'S HYSTERECTOMY WAS NOT PERFORMED AS THE BLEED WAS NOTICED BEFORE THE SURGERY. THE DA VINCI SYSTEM WAS NOT USED. THE ATTORNEY ALSO STATED THAT THE SURGEON DOES NOT FEEL THAT THE PATIENT'S DEATH DID INVOLVE ANY TYPE OF MALFUNCTION OF ANY DEVICE.

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 30 HOURS POST-OP A DA VINCI SI ROUX-EN-Y PROCEDURE ON (B)(6) 2013, DURING AN EXPLORATORY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD AN ANASTOMOTIC LEAK. THE LEAK CAUSED THE PATIENT'S ORGANS TO BECOME ACIDIC AND RESULTED IN THE PATIENT'S DEMISE ON (B)(6) 2013. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT BEGAN TO PRESENT COMPLICATIONS 1 DAY POST-OP. THE PATIENT UNDERWENT AN EXPLORATORY SURGICAL PROCEDURE AND IT WAS DISCOVERED THAT THE PATIENT HAD AN ANASTOMOTIC LEAK. THE AFFECTED AREA WAS REPAIRED. THE SURGEON INDICATED THAT NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE (B)(6) 2013 SURGICAL PROCEDURE AND THAT INTRA-OPERATIVELY THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS. THE SURGEON STATED THAT THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE ANASTOMOTIC LEAK AND SUBSEQUENT DEMISE OF THE PATIENT WERE UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS AND ACCESSORIES. HE STATED THAT THE COMPLICATIONS EXPERIENCED BY THE PATIENT WERE THE RESULT OF THE ANASTOMOTIC LEAK. ON (B)(4) 2013, ISI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY FOR MALIGNANT NEOPLASM OF THE PROSTATE ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND HIS SUBSEQUENT LAPAROTOMIES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS NOTABLE FOR SIGNIFICANT ADHESIONS FROM A PRIOR EXPLORATORY LAPAROTOMY WHICH REQUIRED EXTENSIVE LYSIS OF ADHESIONS PRIOR TO THE DOCKING OF THE ROBOT. THE PROSTATECTOMY PROCEEDED IN A STEPWISE MANNER WITH DROPPING OF THE BLADDER, DISSECTION OF THE ENDOPELVIC FASCIA WITH SHARP DISSECTION, BLUNT DISSECTION OF THE LEVATOR FIBERS, AND INCISION INTO THE JUNCTION BETWEEN THE BLADDER NECK AND THE PROSTATE. THE SURGEON PERFORMED TRANSECTION OF THE SEMINAL VESICLES AND VAS DEFERENCE AND SHARP DIVISION OF THE REMAINING LATERAL ATTACHMENTS. THE POSTERIOR DIVISION BETWEEN THE PROSTATE AND THE RECTUM WAS PERFORMED WITHOUT INJURY TO THE RECTUM. THE DORSAL VENOUS COMPLEX, URETHRA AND REMAINING LATERAL AND POSTERIOR ATTACHMENTS WERE DIVIDED. THE SPECIMEN THEN REMOVED, AND TH

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 ADDITIONAL INFORMATION REGARDING THE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED SACROCOLPOPEXY, CYSTOSCOPY, FULGURATION OF BLADDER LESION, AND REPAIR OF A BLADDER LACERATION FOR CYSTOCELE AND BLADDER LESION ON (B)(6) 2013. THE PATIENT HAD A HISTORY OF BLADDER CANCER. 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. PRIOR TO THE UNDERGOING THE DA VINCI SURGICAL PROCEDURE, INFORMED CONSENT WAS OBTAINED. THE PATIENT HAD A HISTORY OF BLADDER CANCER, PRIOR ABDOMINAL SURGERIES, A HYSTERECTOMY, AND A CHOLECYSTECTOMY. AS A RESULT OF PRIOR SURGERIES, THE PATIENT HAD ADHESIONS. DURING THE SURGERY, AN OPENING IN THE BLADDER WAS NOTED AND REPAIRED. 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. THE ESTIMATED BLOOD LOSS WAS 100 ML. POST-OPERATIVELY, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. AN UNSPECIFIED TIME LATER, THE PATIENT BECAME HYPOTENSIVE, APP

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 UNDERWENT A DA VINCI ASSISTED LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE ON (B)(6) 2013 FOR MORBID OBESITY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND PATIENT'S MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. IN ADDITION, THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. ON POST-OPERATIVE DAY (POD) 1, THE PATIENT'S UPPER GI WAS FOUND TO BE NORMAL. THE PATIENT WAS STARTED ON CLEAR LIQUIDS AND ADVANCED TO FULL LIQUIDS AND PROTEIN DRINK, WHICH SHE TOLERATED WELL. ON (B)(6) 2013, THE PATIENT WAS TOLERATING LIQUIDS AND HER CREATININE LEVEL WAS BACK TO BASELINE AT 2.79. THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, SHE WAS RE-ADMITTED FOR HYDRATION AND DIABETES MANAGEMENT UNTIL BEING DISCHARGED ON (B)(6) 2013. BY (B)(6) 2013, THE PATIENT BEGAN TO DEVELOP INCREASING SHORTNESS OF BREATH, PAIN, CONFUSION AND DISORIENTATION WITH SIGNIFICANT ABDOMINAL DISCOMFORT AND PAIN WITH LOW BLOOD PRESSU

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 SI SURGICAL PROCEDURE, THE PATIENT WAS INJURED BY A PATIENT SIDE MANIPULATOR (PSM) ARM ON THE PATIENT SIDE CART. THE INJURY SUSTAINED BY THE PATIENT WAS LOCATED OUTSIDE OF THE PATIENT'S BODY AT THE ILIAC CREST. 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2012 FOR MENORRHAGIA, DYSMENORRHEA, AND RIGHT OVARIAN CYST. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HANDWRITTEN ER REPORT FROM (B)(6) 2012, DISCHARGE SUMMARY (B)(6) 2012, DOCTORS PROGRESS NOTES FROM (B)(6) 2012, PHYSICIAN'S ORDER FROM (B)(6) 2012. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. SURGERY REVEALED A PRIMARY CYSTO-RECTOCELE, A NORMAL SIZED, QUIET RETROVERTED UTERUS, CYSTIC RIGHT FALLOPIAN TUBE, MILD BOWEL ADHESIONS. AFTER PLACING A V-CARE UTERINE MANIPULATOR TRANSVAGINALLY, A PNEUMOPERITONEUM WAS CREATED WITH THE VERESS NEEDLE AND ADHESIONS WERE TAKEN DOWN WITH MONOPOLAR CAUTERY SHEARS WITHOUT INCIDENT. TUBO-OVARIAN PEDICLES, LATERAL LIGAMENTS, OVARIAN VESSELS AND THE BLADDER FLAP WERE CAUTERIZED WITH A BIPOLAR INSTRUMENT AND TAKEN DOWN WITH MONOPOLAR SHEARS. AFTER COMPLETE MOBILIZATION OF THE UTERUS AN

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A CLINICAL RESEARCH SITE REPORTED THAT STUDY PT (B)(6) RECEIVED CYBERKNIFE TREATMENT FOR PROSTATE CANCER ON (B)(6) 2009. IN (B)(6) 2013, THE PT WAS DIAGNOSED WITH A GRADE 3 PAPILLARY BLADDER TUMOR.

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 RECEIVED A TOTAL HYSTERECTOMY WITH A DA VINCI ROBOT. THE MEASUREMENTS WERE OFF AND I WAS UNDER FOR 11+ HOURS. I WAS TAKEN OFF THE ROBOT AND A REGULAR HYSTERECTOMY WAS PERFORMED. AS A RESULT, I HAVE NUMBNESS AND PAIN IN MY LEFT LEG AND FOOT. I ALSO SUFFERED A ROTATOR CUFF INJURY AND UNDERWENT PHYSICAL THERAPY FOR MY SHOULDER. I STAYED IN THE HOSPITAL FOR 4 NIGHTS AND LOST MORE THAN A THIRD OF MY BLOOD DURING THE SURGERY. RECOVERY WAS STRANGE BECAUSE I HAD MORE PAIN IN MY SHOULDER THAN IN MY INCISION AREAS. MY DOCTOR DID NOT KNOW HOW TO PRESCRIBE MUSCLE RELAXANTS OR PT.

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 THE DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT RETURNED TO THE HOSPITAL SEVERAL DAYS POSTOP COMPLAINING OF ABDOMINAL PAIN. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND A SMALL LACERATION WAS FOUND ON THE PATIENT'S SIGMOID COLON. THE INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE CONTACTED THE SURGEON DIRECTLY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR INDICATED THAT THE SURGEON INFORMED HIM THAT THE ANATOMY WAS VERY DISTORTED DUE TO DISEASE AND THE SURGICAL PROCEDURE WAS AN EXTREMELY TOUGH 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: PT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2013 FOR A PARTIAL HYSTERECTOMY. SURGERY WAS PERFORMED ON (B)(6) 2013. AFTER SURGERY PT SHOULD HAVE AWAKENED AFTER APPROXIMATELY 3 HOURS. TEN HOURS FOLLOWING SURGERY PT WAS PLACED IN ICU. DOCTORS EXPLAINED THAT MEDICATION CAUSED HER TO SLEEP LONGER. PT WAS RELEASED FROM ICU THE FOLLOWING DAY. PT NOTICED CLEAR LIQUID LEAKING FROM HER VAGINA AND SHE HAD TROUBLE BREATHING. SHE SAW DIFFERENT DOCTORS 3 TIMES AND THEN FINALLY WENT TO THE EMERGENCY ROOM. CT SCAN SHOWED SHE HAD PNEUMONIA AND WAS PLACED ON ANTIBIOTICS. FIVE DAYS LATER SHE STILL HAD LEAKING AND TROUBLE BREATHING SO SHE WENT TO A DIFFERENT EMERGENCY ROOM. CT SCAN SHOWED DURING THE ORIGINAL SURGERY THE DOCTOR CUT THE URETER. ONCOLOGIST RECOMMENDED THAT SHE CONTACT HER ORIGINAL SURGEON. SHE HAS APPREHENSIONS ABOUT IT BECAUSE HE MESSED UP THE ORIGINAL SURGERY. HER SURGERY IS SCHEDULED FOR NEXT MONTH. SHE HAS LOST HER JOB BECAUSE OF COMPLICATIONS FROM HER SURGERY. SHE HAS NO MEDICAL INSURANCE AND IS LOOKING INTO BRINGING SUIT. IT HAS BEEN ABOUT A YEAR AND SHE IS STILL EXPERIENCING PAIN.