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 — 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 — 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 — 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 — 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 — 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.

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 GYNECOLOGICAL PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO HER URETER. REPORTEDLY, THE PATIENT REMAINED HOSPITALIZED AND IT IS UNKNOWN WHEN THE PATIENT WOULD BE DISCHARGED. ON (B)(6) 2013, INTUITIVE SURGICAL CONTACTED THE PHYSICIAN'S ASSISTANT (PA) WHO ASSISTED DURING THE SURGICAL PROCEDURE. THE PA INDICATED THAT THE DAMAGE TO THE PATIENT'S URETER WAS DISCOVERED SEVERAL DAYS POST OP WHILE THE PATIENT WAS STILL HOSPITALIZED. THE PA ALSO INDICATED THAT THE PATIENT ALSO DEVELOPED A FISTULA. THE PA DID NOT PROVIDE ANY OTHER INFORMATION.

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 (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: (B)(4) 2014: PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2013 FOR A PARTIAL HYSTERECTOMY. SURGERY WAS PERFORMED ON (B)(6) 2013. AFTER SURGERY PATIENT SHOULD HAVE AWAKENED AFTER APPROXIMATELY 3 HOURS. TEN HOURS FOLLOWING SURGERY PATIENT WAS PLACED IN ICU. DOCTORS EXPLAINED THAT MEDICATION CAUSED HER TO SLEEP LONGER. PATIENT WAS RELEASED FROM ICU THE FOLLOWING DAY. PATIENT 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 AN

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 HYSTERECTOMY PROCEDURE, WHILE PERFORMING SUTURE, THE SURGEON SEWED INTO THE PATIENT'S BLADDER, WHICH CREATED A HOLE IN THE PATIENT'S BLADDER. THE PATIENT'S BLADDER WAS REPAIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. CONTACTED THE PHYSICIAN'S ASSISTANT (PA) THAT WAS ASSISTING DURING THE DA VINCI SURGICAL PROCEDURE. THE PA INDICATED THAT AFTER THE SURGEON HAD COMPLETED CLOSURE OF THE PATIENT'S VAGINAL CUFF AND AFTER THE DA VINCI SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT, A CYSTOSCOPY PERFORMED ON THE PATIENT FOUND THAT THE SURGEON HAD INADVERTENTLY SUTURED THE PATIENT'S BLADDER DURING CLOSURE OF THE PATIENT'S VAGINAL CUFF. THE DA VINCI SURGICAL SYSTEM WAS RE-DOCKED TO THE PATIENT AND THE SURGEON REMOVED THE SUTURE FROM THE PATIENT'S BLADDER AND RE-SUTURED THE PATIENT'S VAGINAL CUFF TO CORRECT THE MISPLACED SUTURE. NO REPAIR TO THE PATIENT'S BLADDER WAS REQUIRED. THE PA INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THAT INADVERTENT SUTURE OF THE PATIENT'S BLADDER BY THE SURGEON 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: 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 URINARY INCONTINENCE AND ERECTILE DYSFUNCTION.

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 HYSTERECTOMY PROCEDURE ON (B)(6) 2013 FOR MENORRHAGIA AND UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND MEDICAL RECORDS RELATED TO A CYSTOSCOPY AND RETROGRADE PYELOGRAPHY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING SURGERY. ACCORDING TO THE DA VINCI OPERATIVE REPORT DATED (B)(6) 2013, THE PROCEDURE WAS NOTED TO BE AN EXTREMELY COMPLICATED CASE, WHICH TOOK ABOUT 4 HOURS AND AS NOTED TO TAKE 2-4 TIMES LONGER THAN NORMAL. THE PATIENT NOTABLY HAD A LARGE UTERUS THAT WEIGHED 650 GRAMS. SHE HAD 2 PREVIOUS C-SECTIONS, WHICH CAUSED SCARRING. THE PATIENT'S URETERS WERE UNDERNEATH A LOT OF SCAR TISSUE; THEREFORE, A CYSTOSCOPY WAS ALSO DONE BECAUSE OF THE COMPLICATED NATURE OF THE PROCEDURE, LYSIS OF SEVERE ADHESIONS WAS DONE AS THE PREVIOUS SURGEON WHO TRIED TO DO HER CHOLECYSTECTOMY COULD NOT EVEN GET INTO HER ABDOMINAL CAVITY. THE SURGEON WAS ABLE TO GET INTO THE PATIENT'S ABDOMINAL CAVITY AND LYSED THESE ADHESIONS. THE RIGHT SIDE OF THE PATIENT'S UTERUS WAS STUCK IN A LOT OF SCAR 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: 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: ROBOT NICKED BLADDER AND URETER, HAD TO INSERT STENTS TO THE URETER TO HEAL HOLE. WOUND UP HAVING BLADDER SPASMS AND BLEEDING, HAD TO HAVE ANOTHER REMOVE STENTS. NOW HAS AN INCONTINENCE AND BLADDER SPASM

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 SI TOTAL HYSTERECTOMY, LEFT SALPINGECTOMY, CYSTOSCOPY AND EXTENSIVE LYSIS OF ADHESIONS FOR MENORRHAGIA, FIBROID UTERUS, PELVIC PAIN AND ANEMIA ON (B)(6) 2013. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT, THE REPORT FROM A CT UROGRAM, AND THE PROCEDURE NOTE FOR THE LATER PLACING OF A STENT. DURING THE PRIMARY SURGICAL PROCEDURE, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. THE OPERATIVE NOTE INDICATED THAT THERE WERE EXTENSIVE DENSE ADHESIONS INVOLVING THE ANTERIOR ABDOMINAL WALL, OMENTUM, BOWEL AND RIGHT TUBE AND OVARY (PATIENT HAD H/O RIGHT SALPINGECTOMY). A MONOPOLAR CURVED SCISSORS INSTRUMENT, MARYLAND DISSECTOR INSTRUMENT AND PROGRASP FORCEPS INSTRUMENT WERE USED TO SEQUENTIALLY COAGULATE WITH BIPOLAR AND EXCISE THE ROUND, BROAD AND UTERO-OVARIAN LIGAMENTS. THE COLPOTOMY WAS MADE AGAINST A KOH CUP. SHARP KNIFE MORCELLATION WAS REQUIRED TO REMOVE THE UTERUS THROUGH THE VAGINA, AND IT WAS NOTED THAT THE ENTIRE PROCEDURE WAS EXTREMELY DIFFICULT DUE TO THE EXTREMELY LARGE SIZE OF THE UTERUS 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 2 DAYS POST A SUCCESSFUL DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE PATIENT WAS TAKEN BACK INTO THE OR PRESENTING SYMPTOMS OF PAIN. IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED A LACERATION OF THE SMALL BOWEL. REPORTEDLY, THE PATIENT WAS RELEASED FROM THE HOSPITAL AND IS RECOVERING FINE.

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 SURGEON ENCOUNTERED A RECOVERABLE FAULT WHILE USING THE VESSEL SEALER INSTRUMENT. THE INITIAL REPORTER (ROBOTICS COORDINATOR) OF THIS COMPLAINT CONTACTED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. HOWEVER, DURING THE CALL, THE ROBOTICS COORDINATOR DID NOT HAVE TIME TO TROUBLESHOOT. THE ROBOTICS COORDINATOR INDICATED THAT THE SURGEON CHOSE TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO TRADITIONAL LAPAROSCOPIC TECHNIQUES. INITIALLY, NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND FOUND AN ERROR 32001 RELATED TO THE VESSEL SEALER INSTRUMENT. AN ERROR 32001 INDICATES THAT THE VESSEL SEAL INSTRUMENT CUTTING BLADE CANNOT BE RETRACTED AND MAY BE EXPOSED.

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 SURGEON CUT ONE OR MORE UNSPECIFIED ARTERIES WHILE ATTEMPTING TO REMOVE LYMPH NODES. ACCORDING TO THE PATIENT, AFTER THE UTERUS, OVARIES, AND FALLOPIAN TUBES WERE REMOVED, THE SURGEON WENT BACK IN TO REMOVE THE LYMPH NODES ON THE RIGHT SIDE. THE PATIENT STATED THAT AS THE LYMPH NODES WERE BEING REMOVED, ARTERIES ATTACHED TO THE LYMPH NODES WERE CUT IN TWO UNSPECIFIED PLACES. A TOTAL OF 14 LYMPH NODES WERE REMOVED. THE SURGEON ATTEMPTED UNSUCCESSFULLY TO REPAIR THE ARTERIES USING THE DA VINCI SURGICAL SYSTEM. A VASCULAR SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY IN ORDER TO REPAIR THE VESSELS. A BLOOD TRANSFUSION WAS ADMINISTERED AND 4 UNITS OF BLOOD WERE GIVEN. THE SURGICAL PROCEDURE TOOK 10 HOURS TO COMPLETE. THE PATIENT INDICATED THAT SHE WAS IN THE ICU FOR EIGHT DAYS POST-OPERATIVELY. IV FLUIDS WERE ADMINISTERED WHICH CAUSED SEVERE BLOATING. AN UNSPECIFIED MEDICATION WAS THEN ADMINISTERED TO ASSIST THE PATIENT WITH FLUID ELIMINATION TO MINIMIZE THE BLOATING. AT AN UNSPECIFIED TIME POST-OPERATIVELY, THE PATIENT INDICATED THAT SHE WENT INTO ATRIAL FIBRILLATION. UPON DISCHARGE FROM THE HOSPITAL, THE PATIEN

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) 2012, DR (B)(6) PERFORMED SURGERY OF THE REMOVAL OF MY LEFT OVARY. THE DA VINCI ROBOTIC ASSIST THE SURGEON. SOON AFTER SURGERY, I BECAME VERY ILL WITH SURGICAL MENOPAUSE. AFTER I REQUESTED A U.S./PELVIC TRANSVAGINAL ULTRASOUND, IT WAS DISCOVERED THE RIGHT OVARY IS NOT IDENTIFIED. IT WAS REMOVED IN ERROR DURING SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE CANNULA MOUNT ON THE PATIENT SIDE MANIPULATOR (PSM) ARM WOULD NOT STAY CLOSED. IT WAS ALSO REPORTED THAT THE PATIENT'S GALLBLADDER, WHICH WAS TO BE REMOVED AS PART OF THE SURGICAL PROCEDURE WAS NICKED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED; HOWEVER; DUE TO THE CANNULA MOUNT NOT STAYING CLOSED, THE SURGICAL TIME WAS LENGTHENED APPROXIMATELY 2 HOURS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6) 2013 - DA VINCI ROBOTIC HYSTERECTOMY. (B)(6) - BACK TO WORK. SEVERE PAIN, CONTINUED SEVERE PAIN. SURGEON'S OFFICE TOLD ME TO SEE UROLOGIST. LAB WORK POSITIVE FOR E COLI AND PSEUDOMONAS AERUGINOSA. FOR MONTHS FOLLOWING CONTINUED PAIN/SEVERE. INFECTIOUS DISEASE DOCTOR - POSITIVE INFECTIONS. (B)(6) 2013 NEUROLOGIST: ABNORMAL EMG - MRI'S ABNORMAL. LEFT HIP LABRUM TEAR - MULTIPLE DISC HERNIATIONS. DR (B)(6) REFERRED TO PAIN MANAGEMENT NEUROLOGIST AT (B)(4) - NERVE BLOCK INJECTIONS. CONCLUSIONS: ILIOINGUINAL NERVE ENTRAPMENT DAMAGE/INJURY. GENITAL FEMORAL NERVE DAMAGE/ENTRAPMENT/COMPRESSION INJURY. THIS ROBOTIC DA VINCI SURGERY HAS LEFT MY BODY IN DISASTROUS PAIN EVERYWHERE. MY INSIDE/INTERNAL BODY BURNS AND IN SEVERE PAIN EVERYWHERE INCLUDING SURGICAL SITE, GENITALIA, RECTAL, ARMS, SHOULDERS. WEAKNESS AND BURNING SENSATION. THIS HAS BEEN CATASTROPHIC AND DEVASTATING. IT IS ALSO KNOWN (I NOW KNOW) THAT CERTAIN BODY TYPES ARE NOT GOOD CANDIDATES FOR ROBOTIC. I AM VERY SLENDER AND RETRACTORS TOO LARGE FOR MY BODY. ALSO POSITIONING FOR GYNECOLOGICAL SURGERIES IS DANGEROUS CAUSING INJURIES OR FATALITIES. TRENDELENBURG AND LITHOTOMY POSITIONS ARE SERIOUSLY DANGEROUS. DA VINCI ROBOTIC H

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, WITH THE USE OF DUAL SURGEON SIDE CONSOLES (SSCS), DURING DISSECTION THE PATIENT'S URETHRA, THE SURGEON EXPERIENCED RESISTANCE ON PATIENT SIDE MANIPULATOR (PSM) ARMS 1 AND 2 WHILE MANIPULATING THE MASTER TOOL MANIPULATORS (MTMS) ON THE SURGEON SIDE CARTS (SSC). THE SURGEON CONTINUED TO MANIPULATE THE MTMS WHEN PSM 1 SUDDENLY MOVED, CAUSING THE INSTALLED MONOPOLAR CURVED SCISSORS INSTRUMENT TO CUT THE PATIENT'S URETHRA. THE SURGEON RECONSTRUCTED THE AFFECTED AREA TO REPAIR THE DAMAGE TO THE PATIENT'S URETHRA AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH 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: IT WAS REPORTED THAT DURING A DA VINCI SURGICAL SI HYSTERECTOMY PROCEDURE, THE PATIENT SUSTAINED A THERMAL INJURY TO THE URETER. 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 WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2013 FOR A HISTORY OF PELVIC PAIN DYSMENORRHEA AND MENORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT FOR BOTH THE PRIMARY SURGERIES AND THE VAGINAL VAULT REPAIR. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PATIENT WAS NOTABLE FOR ADHESIONS OVER THE ANTERIOR UTERINE VESICLE FOLD FROM PREVIOUS C-SECTIONS. THE HYSTERECTOMY PROCEEDED WITH SEQUENTIAL CAUTERY AND TRANSECTION OF THE UTERO-OVARIAN LIGAMENTS, ROUND LIGAMENT, BROAD LIGAMENTS AND UTERINE ARTERY. THE COLPOTOMY WAS PERFORMED WITH MONOPOLAR SCISSORS AND PK FORCEPS, THE UTEROSACRAL LIGAMENTS DESICCATED AND TRANSECTED, AND THE SPECIMEN DELIVERED THROUGH THE VAGINA. THE VAGINA WAS CLOSED WITH QUILL SUTURE. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. THE PATIENT HAD AN UNREMARKABLE POST OPERATIVE COURSE WITH A VAGINAL EXAM AT 4-5 WEEKS SHOWING THE VAGINAL CUFF HEALING NICELY. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE ED WITH SEVERE LOWER ABDOMINAL DISCOMFORT AF

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 HYSTERECTOMY PROCEDURE ON (B)(6) 2013 FOR UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, FOLLOW-UP OPERATIVE REPORTS AND DOCUMENTATION REGARDING URETERAL INJURY. 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 DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2013, PATIENT PRESENTED WITH SYMPTOMS OF ABDOMINAL PAIN AND UNDERWENT A CT SCAN WHICH DEMONSTRATED PARTIAL URETERAL OBSTRUCTION. ON (B)(6) 2013, THE PATIENT UNDERWENT A CYSTOSCOPY WITH PASSAGE OF A STENT. A PARTIAL TRANSECTION OF THE URETER IS SUSPECTED. A URETERAL RE-IMPLANTATION IS PLANNED. 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 A PATIENT UNDERWENT A DA VINCI SI HYSTERECTOMY SURGICAL PROCEDURE AND SUSTAINED A BOWEL INJURY. INTUITIVE SURGICAL INC. (ISI) SPOKE TO THE PATIENT ON (B)(4) 2013 AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2013, THE PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE USING A DA VINCI SI SYSTEM. ON (B)(6) 2013, THE PATIENT DEVELOPED SHARP ABDOMINAL PAINS AND ALSO EXPERIENCED GAS LIKE SYMPTOMS. SHE CONTACTED HER SURGEON AND WAS ADVISED TO TAKE GAS MEDICATION FOR HER SYMPTOMS. ON (B)(6) 2013 AROUND 5:30-6:00PM, HER SYMPTOMS PROGRESSIVELY GOT WORSE, HAD A FEVER OF 102 AND WAS TAKEN TO THE HOSPITAL BY PARAMEDICS. ON (B)(6) 2013, THE PATIENT WENT IN FOR AN X- RAY AND IT WAS DISCOVERED THAT THE PATIENT HAD A CUT BOWEL. THE PATIENT WENT IN FOR SURGERY TO REPAIR HER CUT BOWEL AND IT WAS ALSO DISCOVERED THAT PATIENT HAD AN ABSCESS. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR 14 DAYS FOR AN INFECTION AND RECOVERY OF THE CUT BOWEL. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT.

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 2 DAYS POST OP A SUCCESSFUL DA VINCI SI LEFT SALPINGO-OOPHORECTOMY PROCEDURE, PERFORMED ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM ON (B)(6) 2013 WITH SYMPTOMS OF ABDOMINAL PAIN. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND IT WAS DISCOVERED THAT THE PATIENT HAD FREE AIR IN HER ABDOMEN AND HER SIGMOID COLON WAS DAMAGED AT THE SITE OF DISSECTION DURING THE INITIAL 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: IT WAS REPORTED THAT DURING A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM 1 WAS NOT ROTATING. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THE SITE INSTALLED DIFFERENT INSTRUMENTS AND RESEATED THE STERILE ADAPTER, HOWEVER, THE ISSUE PERSISTED. THE SITE INDICATED THAT THE SURGEON ENCOUNTERED THE ISSUE EVERY TIME HE CHANGED PSMS. THE SITE ADVISED THE TSE THAT THEY WERE CONTINUING WITH THE CASE. APPROXIMATELY 1 HOUR LATER, THE SITE CALLED ISI BACK FOR TECHNICAL SUPPORT ASSISTANCE. THE SITE INDICATED TO THE TSE THAT THE SYSTEM WAS NOT WORKING CORRECTLY AND THAT THE PSM WAS SHAKING. THE SITE DECLINED TO TROUBLESHOOT THE ISSUE WITH THE TSE, AS THEY WERE IN THE MIDDLE OF THE PROCEDURE. THE SITE REQUESTED THAT THE TSE DISPATCH AN ISI FIELD SERVICE ENGINEER TO EVALUATE THE 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY WITH BSO FOR COMPLEX ADNEXAL MASS ON (B)(6) 2013. THE ATTORNEY REPRESENTING THE PATIENT ALLEGED THAT THE PATIENT SUFFERED AN UNSPECIFIED MISCELLANEOUS INJURY. THE PATIENT HAD DENSE ADHESIONS. APPARENTLY THERE WAS A MALFUNCTION OF A PK INSTRUMENT WHICH DID NOT ALLOW IT TO FIRE; HOWEVER, OTHER INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY EFFECT ON THE PROCEDURE OR THE PATIENT. NO MEDICAL RECORDS AFTER (B)(6) 2013 WERE 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: URETER WAS CUT, INFECTION (HAD TO BE PUT ON ANTIBIOTICS), SURGICAL CORRECTION.