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 GALL BLADDER REMOVAL AND HERNIA REPAIR PROCEDURE ON (B)(6) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: HERNIA RUPTURED HAD TO HAVE A RESECTION 4 DAYS AFTER HERNIA REPAIR AND HAD RUPTURED HERNIA LEAKED INTO THE SMALL BOWEL. PATIENT HAD TO REMOVE 4' OF HER INTESTINE/ BOWEL.

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, INTUITIVE SURGICAL, INC. (ISI), RECEIVED INFORMATION AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH CYSTOSCOPY PROCEDURE ON (B)(6) 2013. THE PATIENT'S PREOPERATIVE DIAGNOSIS INCLUDED BILATERAL PELVIC ENDOMETRIOSIS. ON (B)(6) 2013, THE PATIENT UNDERWENT A FLUOROSCOPY PROCEDURE AND IT WAS DISCOVERED THAT THE PATIENT HAD A PERIRECTAL OR PRESIGMOID MASS DEFORMING THE COLON WITH AN ASSOCIATED RECTOVAGINAL FISTULA. ACCORDING TO THE OPERATIVE (OR) REPORT REGARDING THE SURGERY ON (B)(6) 2013, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS STATED THAT A CYSTOSCOPY PERFORMED DURING THE PROCEDURE SHOWED NO INJURY TO THE PATIENT'S BLADDER AND BILATERAL URETERAL EFFLUX. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. IT WAS STATED THAT THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE PATIENT'S PROGRESS NOTES DATED (B)(6) 2013, POST-OPERATIVELY THE PATIENT DEVELOPED HIGH FEVERS

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 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 A DA VINCI ST BENIGN HYSTERECTOMY PROCEDURE WAS PERFORMED, THE PATIENT CAME BACK TO THE HOSPITAL WITH POST-OPERATIVE SYMPTOMS OF PRESSURE AND BLOATING. THE SURGEON OPENED THE PATIENT AND REPORTEDLY NOTICED A SMALL BOWEL INJURY. THE SURGEON PROCEEDED TO PERFORM A BOWEL RESECTION PROCEDURE. DURING THE BOWEL RESECTION PROCEDURE, THE PATIENT WAS PLACED ON A VENTILATOR. THE PATIENT REPORTEDLY ALMOST PASSED AWAY DURING THE BOWEL RESECTION PROCEDURE FOR AN UNKNOWN REASON. AT THE TIME THE INITIAL REPORTER REPORTED THE EVENT TO INTUITIVE SURGICAL INC. (ISI), THE PATIENT WAS IN THE ICU AND WAS DOING 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 SI 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: 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 — 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 LEFT UPPER LOBECTOMY PROCEDURE FOR A LEFT UPPER LOBE MASS ON (B)(6) 2013. 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. PER THE OPERATIVE REPORT, ADHESIONS BETWEEN THE UPPER CHEST WALL AND THE LATERAL CHEST WALL OF THE LUNG WERE TAKEN DOWN USING HOOK CAUTERY. DISSECTION IN THE FISSURE PROCEEDED UNTIL SOME OF THE PULMONARY ARTERY BRANCHES COULD BE IDENTIFIED AND SEALED USING THE VESSEL SEALER INSTRUMENT. THE SURGEON NOTED, WE THEN WENT AHEAD AND CONTINUED WITH DISSECTION IN THE FISSURE UTILIZING AN ELECTROCAUTERY TO HELP EXPOSE WITH PULMONARY ARTERY...AT THIS POINT BECAUSE OF THE SIGNIFICANT ADHESIONS IN THE FISSURE, I WENT AHEAD AND DISSECTED PROXIMALLY IDENTIFYING THE PULMONARY VEIN. DISSECTION CONTINUED AND THE LUNG RESECTION WAS SUBSEQUENTLY COMPLETED. THE SURGEON INDICATED...AND AT THIS TIME I NOTED SOME BLEEDING COMING FROM THE TRUNCAL BRANCHES OF THE PULMONARY ARTERY. WE GRASPED WITH 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY 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 THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2013, AND ON (B)(6) 2013, THE PATIENT ALLEGEDLY EXPERIENCED SEPTIC SHOCK. THE SURGEON INDICATED THAT THE HYSTERECTOMY PROCEDURE WENT WELL AND HE DID NOT OBSERVE ANY ERRORS DURING THE CASE. ACCORDING TO THE SURGEON, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) IN SEPTIC SHOCK ON (B)(6) 2013, AND A SECOND DOCTOR PERFORMED A DIAGNOSTIC LAPAROTOMY. DURING THE DIAGNOSTIC LAPAROTOMY, THE SURGEON WHO PERFORMED THE HYSTERECTOMY PROCEDURE WAS PRESENT. HE CLAIMED THAT NO FACTORS WERE IDENTIFIED FOR THE CAUSE OF THE SEPSIS DURING THE DIAGNOSTIC LAPAROTOMY. THE SECOND DOCTOR THEN PERFORMED AN EXPLORATORY LAPAROTOMY PER THE REQUEST OF THE SURGEON SINCE THE PATIENT WAS IN SEPSIS. DURING THE EXPLORATORY LAPAROTOMY, THE PATIENT'S APPENDIX WAS FOUND TO BE INFLAMED AND A SMALL MARK WAS OBSERVED ON THE PATIENT'S BOWEL. THE SURGEON DENIED THAT FECES WAS OBSERVED IN THE PATIENT'S ABDOMINAL CAVITY. THE SECOND DOCTOR REPORTEDLY APPLIED SEVERAL SUTURES OVER THE SMALL MARK ON THE PATIENT'S BOWEL AND A TEMPORARY DIVERTING ILEOSTOMY WAS CREATED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY AND EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2013 FOR POORLY DIFFERENTIATED CARCINOMA OF PROBABLE ENDOMETRIAL ORIGIN, POSTMENOPAUSAL BLEEDING, ENLARGED UTERUS AND EXTENSIVE INTRAPERITONEAL ADHESIONS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, A CYSTOSCOPY PERFORMED AT THE CONCLUSION OF THE DA VINCI SURGICAL PROCEDURE SHOWED GOOD EFFLUX OF URINE BILATERALLY FROM THE URETERAL OSTIA, AND NO VISIBLE BLADDER DEFECTS. NO OPERATIVE COMPLICATIONS WERE NOTED, AND THE ESTIMATED BLOOD LOSS WAS 150 ML. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. THE DISCHARGE SUMMARY WAS NOT AVAILABLE FOR REVIEW. ON (B)(6) 2013, THE PATIENT PRESENTED TO AN ER WITH COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, VOMITING, AND DIARRHEA. A CT-SCAN SHOWED MULTIPLE DILATED LOOPS OF FLUID FILLED BOWEL CONSISTENT

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 SI SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2013 FOR MASSIVE FIBROID UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP RADIOLOGY REPORTS. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2013, THE PATIENT REPORTED LEAKING URINE PER VAGINA. ON (B)(6) 2013, SHE PRESENTED TO A DIFFERENT HOSPITAL WITH FREE FLUID IN HER ABDOMEN AND PELVIS. SHE HAD ACUTE RENAL FAILURE, WHICH RESOLVED. SHE REQUIRED PARACENTESIS TO REMOVE THE FREE ABDOMINAL/PELVIC FLUID AND A CYSTOSCOPY WITH RETROGRADE PYELOGRAMS REVEALED A HEALING 1 CM BLADDER LACERATION AT THE RIGHT DOME. ADDITIONAL CYSTOSCOPY REVEALED ONGOING LEAKAGE WITH BLADDER DISTENTION. A FOLEY CATHETER WAS LEFT IN PLACE FOR APPROXIMATELY 2 WEEKS. SHE MISSED A TOTAL OF APPROXIMATELY 6 WEEKS OF WORK (4 MORE WEEKS THAN ANTICIPATED).

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 DAVINCI HYSTERECTOMY AND LYSIS OF ADHESIONS FOR A HISTORY OF DYSFUNCTIONAL UTERINE BLEEDING, PELVIC PAIN, UTERINE FIBROID, AND PRESENCE OF EXTENSIVE ABDOMINAL/PELVIC ADHESIONS ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE URETERAL REIMPLANTATION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS NOTABLE FOR THE EXTENSIVE ABDOMINAL ADHESIONS FROM THE ANTERIOR PORTION OF THE UTERUS TO THE ANTERIOR WALL OF THE ABDOMEN WHICH HAD TO BE TAKEN DOWN WITH AN ENSEAL LIGATOR BEFORE THE HYSTERECTOMY COULD START. THE UTERINE CORNEAL ATTACHMENTS, AND UTERINE VESSELS WERE CAUTERIZED AND CUT, THE BLADDER WAS BLUNTLY AND SHARPLY DISSECTED INFERIORLY AND THE CULPOTOMY COMPLETED. THE UTERUS WAS DELIVERED THROUGH THE VAGINA, AND THE VAGINAL CUFF CLOSED WITH V-LOCK SUTURES. THE CYSTOSCOPY WAS PERFORMED WITH IV INDIGO CARMINE, AND BOTH URETERAL ORIFICES WERE SEEN EJECTING DYE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2013 PATIENT PRESENTED WI

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 PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT SIDE MANIPULATOR ARM 1 BEHAVED IN A SLUGGISH MANNER. THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING AND INDICATED THAT THEY TROUBLESHOT THE ISSUE BY INSTALLING DIFFERENT INSTRUMENTS ONTO TO THE AFFECTED PSM; HOWEVER, THE ISSUE PERSISTED. THE OR NURSE INDICATED TO THE TSE THAT THEY WERE NOT VERY DEEP INTO THE PATIENT AND THAT THEY COULD NOT OBSERVE ANY INTERFERENCE WITH THE INSTRUMENT OR PSM. THE SITE DECLINED FURTHER TROUBLE-SHOOTING ASSISTANCE AND INDICATED THAT THEY WERE GOING TO PROCEED WITH THE PROCEDURE. ON (B)(4) 2013, THE ISI CLINICAL SALES REPRESENTATIVE FOLLOWED UP WITH THE SURGEON CONCERNING THE REPORTED EVENT. THE CSR INDICATED THAT THE SURGEON INDICATED TO HIM THAT THE PATIENT'S VENA CAVA WAS DAMAGED EARLIER IN THE PROCEDURE AND DURING REPAIR OF THE PATIENT'S ANATOMY, HE EXPERIENCED ARTICULATION ISSUES WITH THE INSTRUMENTS INSTALLED ON THE 1 PSM AND THE 2 PSM. THE CSR INDICATED THAT THE SURGICAL STAFF TROUBLESHOT THE ISSUE BY RESEATING THE INSTRUMENTS AND THE STERILE ADAPTERS. HOWEVER, THE INSTALLED INSTRUMENTS INTERMITTENTLY FAILED TO ARTICULATE PROPERLY. THE CSR INDICATED THAT 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: DURING A USER INTERVIEW, IT WAS REPORTED TO ISI THAT A NURSE WAS INJURED AS SHE TRIED TO PULL THE PATIENT CART OF THE DA VINCI SURGICAL SYSTEM BACKWARDS (DATE OF EVENT WAS UNKNOWN; HOWEVER, IT WAS STATED THAT THIS HAS OCCURRED A WHILE AGO). REPORTEDLY, THE NURSE MAY HAVE GRABBED THE HANDLES TOO HARD AND THE PATIENT CART WENT BACK TOO FAR. ALLEGEDLY, THE NURSE'S HAND GOT STUCK BETWEEN THE WALL AND THE DA VINCI SYSTEM, AND SHE WAS UNABLE TO LET GO. ACCORDING TO THE REPORTER OF THIS COMPLAINT, THE NURSE WAS OUT FOR 6-8 WEEKS, BUT NOTHING WAS BROKEN.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A WALL STREET JOURNAL ARTICLE INDICATED THE FOLLOWING DETAILS RELATED TO PATIENT DEATH: 'A FOLLOW-UP STORY REFERRED TO A CASE IN WHICH A (B)(6) MAN DIED FOLLOWING ROBOTIC SURGERY LAST SUMMER AT A (B)(6) HOSPITAL. AN ATTORNEY FOR THE MAN'S FAMILY SAID THE UROLOGIST WHO OPERATED ON HIM HAD NEVER BEFORE PERFORMED THE PROCEDURE HE WAS ATTEMPTING WITH THE ROBOT, ACCORDING TO THE 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY 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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN A PUBLISHED CITRON RESEARCH ARTICLE TITLED INTUITIVE SURGICAL: ANGEL WITH BROKEN WINGS, OR DEVIL IN DISGUISE? ON JANUARY 17, 2013, IT WAS STATED ON PAGE 22 IN AN EMBEDDED ARTICLE LINK (CHICAGO DAILY LAW BULLETIN - FAMILY GETS $7.5 MILLION IN DEATH AFTER SPLEEN REMOVAL) THAT A (B)(6) MAN DIED ONE MONTH AFTER A DA VINCI SURGERY TO REMOVE HIS SPLEEN IN 2007. ALLEGEDLY, THE DECEDENT UNDERWENT THE SURGERY BECAUSE HE SUFFERED FROM A DISORDER THAT PREVENTED HIS BLOOD FROM PROPERLY CLOTTING. THE DECEDENT ALLEGEDLY SUFFERED TWO HOLES IN HIS DUODENUM, AN ORGAN THAT IS 6 TO 10 INCHES FROM THE SPLEEN. FURTHERMORE, ACCORDING TO THE ARTICLE, HE BECAME SICK AND DEVELOPED SEPSIS THAT CAUSED SEVERAL ORGANS TO FAIL POST-SURGERY. IT WAS ALSO ALLEGED THAT HE SUFFERED BRAIN DAMAGE AND DIED IN (B)(6) 2007. A MEDICAL-MALPRACTICE LAWSUIT WAS FILED AGAINST FOUR DOCTORS OF THE (B)(6) -BASED HOSPITAL, WHO REPORTEDLY DENIED THE ALLEGATION THAT THE DUODENUM HOLES OCCURRED DURING THE SURGERY. INTUITIVE SURGICAL WAS NOT NAMED AS A DEFENDANT IN THIS LAWSUIT. THESE ALLEGATIONS WERE NOT PREVIOUSLY REPORTED TO INTUITIVE SURGICAL AND HAVE NOT BEEN SUBSTANTIATED. ANY FURTHER INFORMATION RECEIVED BY THE COMPANY WILL

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 TOTAL HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY AND ADHESIOLYSIS FOR SYMPTOMATIC UTERINE LEIOMYOMAS AND ABDOMINAL ENDOPELVIC ADHESIONS ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH ALL OPERATIVE REPORTS. ADDITIONAL INFORMATION PROVIDED INCLUDES: PROGRESS NOTES (B)(6) 2013. 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. AFTER PLACEMENT OF THE V-CARE CUP AND CREATION OF A PNEUMOPERITONEUM WITH THE VERESS NEEDLE, 4 PORTS WERE PLACED UNDER VISUAL CONTROL AND THE ROBOT DOCKED. A MONOPOLAR INSTRUMENT, THE PK AND THE GRASPER WERE USED DURING THE PROCEDURE. ADHESIOLYSIS OF THE OMENTUM FROM THE ANTERIOR ABDOMINAL WALL, THE ANTERIOR FUNDUS AND THE RIGHT TUBE AND OVARY WAS CARRIED OUT. UTERO-OVARIAN LIGAMENTS AND ROUND LIGAMENTS WERE CAUTERIZED AND TRANSECTED BILATERALLY. SUBSEQUENTLY, DEVELOPMENT OF THE VESICOUTERINE PERITONEUM AND THE BLADDER FLAP, CAUTERIZATION AND TRANSECTION OF THE SKELETONIZED UTERINE VESSELS WITH PK AND MONOPOLAR. THE SURGEON 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 MEDIATION EFFORT ON (B)(6) 2013, INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND A MINIARC VAGINAL SLING PROCEDURE ON (B)(6) 2013. THE OPERATIVE REPORT FOR THESE PROCEDURES INDICATE THEY WERE SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURES WELL. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION AND DISCHARGED HOME THE NEXT DAY,(B)(6) 2013. ACCORDING TO THE HOSPITAL RECORDS, THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2013, WITH COMPLAINTS OF VAGINAL CRAMPING AND BLEEDING FOLLOWING FIRST POST-OPERATIVE SEXUAL INTERCOURSE. PATIENT ALSO REPORTED PAIN WITH BOWEL MOVEMENT. PELVIC EXAM FOUND VAGINAL CUFF DEHISCENCE WITH MINOR BOWEL EVISCERATION. PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR GYNECOLOGICAL CARE, AND UNDERWENT A TRANSVAGINAL REPAIR AND REVISION OF THE VAGINAL CUFF ON (B)(6) 2013. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN ST

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 INITIALLY REPORTED THAT DURING A DA VINCI SI SIGMOID COLECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED A PROBLEM WITH ONE OF THE PATIENT SIDE MANIPULATOR (PSM) ARMS. THE CUSTOMER REPORTED THAT THE PSM ARM 1 WAS NOT FOLLOWING THE MOVEMENTS OF THE SURGEON PROPERLY DURING THE CASE. IT WAS ALLEGED THAT THE BED SIDE ASSISTANT WAS LOOKING AT THE DRAPES WHEN THE ARM MOVED FORWARD AND CONTACTED THE PATIENT'S AORTA. THE CUSTOMER CONVERTED TO AN OPEN PROCEDURE AND A VASCULAR SURGEON WAS CALLED TO REPAIR THE DAMAGE. IT WAS ALSO REPORTED THAT THE SITE WAS UNSURE IF THE ARM WAS TOUCHED OR IF THE SURGEON HAD HIS HEAD IN THE VIEWER WITH HIS HANDS OFF THE MASTER. THE SURGEON REPORTED TO THE CLINICAL SALES REPRESENTATIVE: IT IS CLEAR TO ME THAT THERE WAS PENT UP ENERGY STORED ON THE ARM OF THE ROBOT. WHEN THIS WAS RELEASED THE INSTRUMENT SHOT FORWARD WITH A FORCE AND AT A SPEED GREATER THAN HUMANLY POSSIBLE. IT THEN APPEARED TO SET BACK HALF WAY BETWEEN THE STARTING POINT (WHERE IT WAS NOT FUNCTIONING) AND THE POINT OF MAXIMAL CONTACT IN THE RETROPERITONEUM. I AM NOT SURE WHETHER THE RECOIL AFTER THE STABBING WAS THE ROBOT RETURNING TO A REST OR ME INSTINCTIVELY PULLING BACK ON THE CONTROLS. 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 POST A DA VINCI S HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT SUSTAINED RECTAL/COLON INJURIES, WHICH REQUIRED THE PATIENT TO UNDERGO ADDITIONAL SURGICAL PROCEDURES.

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 ALLEGED THAT THE PATIENT HAD A MULTI-PORT CHOLECYSTECTOMY ON (B)(6) 2013 THAT RESULTED IN AN INJURY TO THE BOWEL FROM THE TROCAR DURING INSERTION AT THE BEGINNING OF THE CASE. THE PATIENT COMPLAINED ABOUT PAIN TWO DAYS AFTER THE SURGERY AND RETURNED TO THE HOSPITAL. THE PATIENT WAS READMITTED, ALLEGEDLY SEPTIC AND AN EMERGENCY SURGERY WAS PERFORMED TO REPAIR THE BOWEL. THE PATIENT EXPIRED 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI NEPHRECTOMY FOR AN UNKNOWN REASON ON (B)(6) 2013. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: THE PATIENT WAS TO HAVE A PARTIAL NEPHRECTOMY, BUT BECAUSE OF COMPLICATIONS WITH THE DA VINCI HIS ENTIRE KIDNEY WAS REMOVED. HE DEVELOPED A HERNIA AND UNDERWENT ANOTHER DA VINCI ASSISTED SURGERY TO REPAIR THE HERNIA, HOWEVER THE ROBOT MALFUNCTIONED AND THE SURGERY WAS UNABLE TO BE COMPLETED. ON YET THE THIRD DAY, THE PATIENT, UNDERWENT ANOTHER DA VINCI SURGERY TO REPAIR THE HERNIA. HE SUFFERED COMPLICATIONS, BECAME SEPTIC AND EXPIRED 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI OOPHORECTOMY PROCEDURE IN (B)(6) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PUNCTURED BLOOD VESSEL, CAUSED INTERNAL BLEEDING AND HAD SURGICAL CORRECTION.

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)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A MEDICAL RECORDS SUMMARY REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2013. THE INFORMATION RECEIVED ALLEGES THAT THE PATIENT'S OPERATIVE REPORT DESCRIBED THAT THE PATIENT HAD A MASS THAT ADHERED TO THE ILIAC VEIN AND DURING DISSECTION THE ILIAC VEIN WAS TORN. THE PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. A VASCULAR SURGEON WAS CONSULTED TO REPAIR THE PATIENT'S VESSEL. THE MEDICAL SUMMARY AS PROVIDED INDICATES THAT DURING THE SURGICAL PROCEDURE THE DAMAGE TO THE PATIENT'S VESSEL WAS NOTED DURING DISSECTION USING A HARMONIC SHEARS INSTRUMENT. THE OPEN LAPAROTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE WELL. DURING THE PATIENT'S HOSPITALIZATION, THE PATIENT WAS DIAGNOSED WITH RIGHT COMMON FEMORAL DEEP VEIN THROMBUS AND WAS TREATED WITH MEDICATIONS TO TREAT HER CONDITION. ON THE 7TH DAY OF THE PATIENT'S HOSPITALIZATION THE PATIENT WAS ANEMIC AND WAS GIVEN TWO UNITS OF RED BLOOD CELL. ON THE 11TH DAY THE PATIENT'S PAIN WAS WELL CONTROLLED, TOLERATING A REGULAR DIET, PASSING FLATUS AND BOWEL MOVEMENTS,

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: 'ABCESS, DIFFICULTY WITH BOWEL MOVMENTS, DYSPAREUNIA, SCAR TISSUE'

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 TO ISI THAT A FEW DAYS AFTER A DA VINCI SI PYLOROPLASTY PROCEDURE, THE PATIENT EXPERIENCED PROBLEMS WITH HIGH FEVER. AFTER CONSULTING WITH HIS SURGEON, HE WAS BROUGHT BACK TO THE EMERGENCY ROOM FOR AN EXPLORATORY SURGERY. IT WAS ALLEGED THAT DURING THE OPEN TRADITIONAL SURGERY A 3CM HOLE WAS FOUND ON THE PATIENT'S BOWEL. IT WAS REPORTED THAT THE SURGEON REMOVED 6 OF THE PATIENT'S COLON AND A COLOSTOMY BAG WAS INSTALLED. THE PATIENT WAS LATER TRANSFERRED FROM THE INTENSIVE CARE UNIT TO A PRIVATE ROOM.

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 OF A SUCCESSFUL DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS REMOVING THE CANNULA FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUSTAINED BURN MARKS ON THE SURFACE OF THE SKIN ASSOCIATED WITH PATIENT SIDE MANIPULATOR (PSM) ARM 2.

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 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. 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 AFTER OF A SUCCESSFUL DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS REMOVING THE CANNULA FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUSTAINED BURN MARKS ON THE SURFACE OF THE SKIN. THIS MDR WAS CREATED TO ADDRESS THE EVENT OCCURRED ON (B)(6) 2013; REPORTED BY DAVINCI COORDINATOR ON RELATED MDR 2955842-2013-00666.

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 SI HYSTERECTOMY AND CYSTOSCOPY FOR ENDOMETRIAL HYPERPLASIA, MENORRHAGIA AND DYSMENORRHEA ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, AND THE PROCEDURE REPORTS FOR URETERAL STENT PLACEMENT AND STENT REMOVAL. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE SURGERY WAS PERFORMED WITH FENESTRATED BIPOLAR AND AN UNSTATED INSTRUMENT WITH ROUTINE CAUTERIZATION AND TRANSECTION OF UTERO-OVARIAN LIGAMENTS, ARTERIES AND FALLOPIAN TUBES WITH VAGINAL DELIVERY OF THE UTERUS, CAUTERY OF BLEEDERS ON THE VAGINAL VAULT, AND CLOSURE WITH BARBED SUTURE. UPON ROUTINE CYSTOSCOPY WITH INDIGO CARMINE, IT WAS NOTED THAT THERE WAS NO EFFLUX FROM THE RIGHT URETERAL ORIFICE. A UROLOGIST WAS CONSULTED WHO PERFORMED BILATERAL RETROGRADE PYELOGRAMS. HE PLACED A 6 FRX26 CM DOUBLE PIGTAIL STENT IN THE RIGHT URETER BECAUSE OF THE CONCERN THAT THE HYDROURETERAL NEPHROSIS INDICATED THERMAL INJURY TO THE URETER. THE SURGERY WAS COMPLETED, AND PATIENT DISCHARGED WITH STENT. ON (B)(6) 2013, PATIENT HAD A C

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, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2013. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF UTERINE FIBROIDS AND HISTORY OF BREAST CANCER. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT THE SURGICAL STAFF HAD DIFFICULTY WITH VISUALIZATION SINCE THERE WAS A LARGE FIBROID THAT WAS ANTERIOR IN THE LOWER UTERINE SEGMENT. AT THAT POINT, THE 30-DEGREES CAMERA WAS REPLACED WITH A STRAIGHT CAMERA AND VISUALIZATION WAS NOTED AS BEING BETTER. DUE TO THE LARGE SIZE OF THE UTERUS, THE SURGICAL STAFF FACED DIFFICULTIES REMOVING THE UTERUS VAGINALLY. HENCE, AFTER THE VAGINAL CUFF WAS CLOSED, THE DA VINCI SYSTEM WAS UNDOCKED AND THE UTERUS, TUBES, AND OVARIES WERE REMOVED BY LAPAROSCOPIC MORCELLATION. THE PELVIS WAS WELL IRRIGATED AND THE PATIENT HAD GOOD HEMOSTASIS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AN ARTICLE ENTITLED PATIENT SAYS BROKEN DA VINCI ROBOT CAUSED A PERFORATED COLON THAT LED TO DISTURBING GI COMPLICATIONS PUBLISHED ON (B)(4) 2011 BY (B)(4) WAS PROVIDED TO INTUITIVE SURGICAL ON (B)(4) 2013. THE ARTICLE ALLEGES THAT DURING THE PATIENT'S PROSTATECTOMY PROCEDURE IN JANUARY 2007 THE SYSTEM MALFUNCTIONED AND THE SURGICAL PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. THE PATIENT WAS REPORTED TO HAVE GONE INTO RECOVERY IN GOOD CONDITION, HOWEVER, ON HIS WAY HOME FROM THE HOSPITAL HE SENSED THAT THE PROSTATECTOMY HAD GONE WRONG. THE ARTICLE ALLEGED THAT THE PATIENT BEGAN URINATING OUT OF HIS RECTUM AND NOTICED THAT DARK MATTER WAS COMING OUT OF HIS PENIS.

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 S UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS AND CYSTOSCOPY FOR ABNORMAL UTERINE BLEEDING AND PELVIC PAIN ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. MULTIPLE SEVERE ADHESIONS WERE ENCOUNTERED DURING THE PROCEDURE, THE UTERUS WAS STUCK TO THE ANTERIOR ABDOMINAL WALL. OVARIAN CYSTS WERE PRESENT. A CYSTOSCOPY WAS PERFORMED POST-PROCEDURE TO ENSURE THAT NO DAMAGE WAS DONE TO THE BLADDER OR URETERS. THE PATIENT WAS DISCHARGED TO HER RESIDENCE THE FOLLOWING DAY, (B)(6)2013 IN STABLE CONDITION. DURING A POST-OPERATIVE VISIT ON (B)(6) 2013 THE PATIENT COMPLAINED OF POST-OPERATIVE PELVIC PAIN. SHE WAS ADMITTED TO THE HOSPITAL, WHERE A CT SCAN REVEALED A MIXED-DENSITY MASS ABOVE THE PATIENT'S BLADDER AND POTENTIAL URETERAL DILATION, BUT THE IMAGES WERE OF POOR QUALITY. BLOOD TEST SHOWED CREATININE IS 0.71, SODIUM 139, POTASSIUM 3.5, CALCIUM 9.4. LIVER FUNCTION WAS NORMAL. HEMO

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS INITIAL MDR IS ACTUALLY BEING SUBMITTED AS A FOLLOW-UP #1 MDR REPORT FOR MFR REPORT #2955842-2014-02551 (PATIENT IDENTIFIER (B)(6)). THE COMPLAINT HANDLING SYSTEM THAT WAS USED TO SUBMIT THE INITIAL MDR IS NO LONGER AVAILABLE FOR MDR REPORT SUBMISSIONS. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE PLAINTIFF¿S ATTORNEY: THE DEATH CERTIFICATE INDICATED THAT THE PATIENT¿S CAUSE OF DEATH WAS ¿SEPSIS¿ DUE TO OR AS A CONSEQUENCE OF ¿ACUTE OR CHRONIC RESPIRATORY FAILURE,¿ DUE TO OR AS A CONSEQUENCE OF ¿FALLOPIAN TUBE DAMAGE,¿ DUE TO OR AS A CONSEQUENCE OF ¿COPD AND OSA.¿ BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED A PELVIC ABSCESS AND SEPTIC SHOCK, AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 6 WEEKS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S ALLEGED PELVIC ABSCESS IS STILL UNKNOWN.

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 HYSTERECTOMY FOR FIBROIDS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND SUPPLEMENTAL HOSPITAL MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED THAT THERE WAS SOME DIFFICULTY PLACING TROCARS DUE TO DENSE INTRA-ABDOMINAL ADHESIONS. PERTINENT FINDINGS INCLUDED ADHESIONS OF THE BOWEL AND OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR AN ACCESSORY DURING THE OPERATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2013 THE PATIENT PRESENTED WITH LEAKING FLUID FROM HER VAGINA. A CYSTOSCOPY WAS PERFORMED WITH BILATERAL RETROGRADE PYELOGRAPHY. NO URINARY INJURY WAS DETECTED. A DIAGNOSTIC LAPAROSCOPY WAS INITIATED BUT THEN ABANDONED DUE TO ADHESIONS. ON (B)(6) 2013, AN EXPLORATORY LAPAROTOMY WAS THEN PERFORMED. THE BOWEL WAS FOUND TO BE DENSELY ADHERENT TO THE UPPER ANTERIOR ABDOMINAL WALL. PELVIC ABSCESSES WERE IDENTIFIED AND

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 S PROSTATECTOMY PROCEDURE, DURING STARTUP OF THE DA VINCI S SYSTEM, THE CUSTOMER EXPERIENCED A PROBLEM WITH ERROR CODE 45341. THE SITE CONTACTED ISI FOR TECHNICAL SUPPORT ENGINEERING (TSE) ASSISTANCE. REVIEW OF THE SITE'S SYSTEM LOG BY THE TSE FOUND THAT THE SYSTEM ERROR CODE 45341 WAS RELATED TO THE VIDEO PROCESS ASSEMBLY ON THE DA VINCI S ROBOT SYSTEM. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM OR INJURY WAS INITIALLY REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013, INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE DUE TO ABNORMAL UTERINE BLEEDING. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. ACCORDING TO THE INFORMATION IN THE OP REPORT, DURING THE SURGICAL PROCEDURE, A SMALL ARTERIAL BLEEDER FROM WHAT APPEARED TO BE FROM AN ASCENDING CERVICAL BRANCH WAS APPRECIATED. THERE WERE CONCERNS ABOUT FURTHER CONTINUATION OF CAUTERY ENERGY IN THIS AREA AND A CLIP WAS APPLIED TO CONTROL THE BLEEDING. BASED ON THE INFORMATION AS PROVIDED IN THE OP REPORT THERE WERE NO OTHER ISSUES ENCOUNTERED DURING THE SURGICAL PROCEDURE. AFTER COMPLETION OF THE SURGICAL PROCEDURE THE PATIENT'S URINE WAS FOUND TO BE CLEAR. A CYSTOSCOPE WAS PLACED AND IT WAS CONFIRMED THAT THERE WAS NO TRAUMA TO THE PATIENT'S URINARY COLLECTING SYSTEM, AS THE BLADDER MUCOSA WAS CLEAR. INDIGO CARMINE FROM BOTH URETERS WAS OBSERVED. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(

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 APPROXIMATELY TWO WEEKS AFTER SUCCESSFUL COMPLETION OF A DA VINCI SI SINGLE SITE CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AS A RESULT OF AN ALLEGED BOWEL PERFORATION. REPORTEDLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES TO REPAIR THE AFFECTED AREA.

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: RUPTURED BLOOD VESSELS, PATIENT STILL HAS NO FEELING IN HER THIGHS, NOW PRONE TO UTIS AND PAINFUL INTERCOURSE.

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 TRANSORAL ROBOTIC SURGERY (TORS), THE PATIENT SUFFERED A LIP BURN. IT WAS CONFIRMED THAT THE INCORRECT 3-PRONGED GROUNDING PAD WAS USED. THE SITE WAS PHYSICALLY REMOVING THE THIRD PIN IN ORDER TO CONNECT IT TO THE CANNULA. THIS COULD BE A POSSIBLE FAILURE MECHANISM AS THIS WOULD CONSTITUTE AN UNVALIDATED USE OF THE PRODUCT.

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)(4) 2013, INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE OPERATIVE (OP) REPORT FOR THE PATIENT'S HYSTERECTOMY PROCEDURE ON (B)(6) 2013 WAS NOT PROVIDED. THE PATIENT'S MEDICAL SUMMARY ALLEGES THAT THE PATIENT UNDERWENT THE DA VINCI HYSTERECTOMY PROCEDURE SECONDARY TO FAILED MEDICAL MANAGEMENT OF DYSMENORRHEA AND MENORRHAGIA. THE SURGICAL PROCEDURE WAS APPARENTLY COMPLICATED DUE TO DENSE PELVIC ADHESIONS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH HER POSTOPERATIVE COURSE COMPLICATED BY PANIC ATTACK. POST OPERATIVELY THE PATIENT REPORTED THAT SHE HAD SOME RIGHT SHOULDER PAIN AS WELL AS BLOATING AND WAS MANAGED CONSERVATIVELY WITH REST, HYDRATION AND STOOL SOFTENERS, HOWEVER, HER PAIN WORSENED. THE PATIENT'S MEDICAL REPORTS PROVIDED STATE THAT WHEN THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013, THE PATIENT DESCRIBED HER PAIN AS BEING SO INTENSE THAT SHE COULD NOT EAT OR DRINK. THE PATIENT ALSO REPORTED FEVER AND VOMITING. ABDOMEN AND PELVIC CT TESTS WERE ORDERED. NO SIGNIFICANT INTRA-ABDOMINAL FINDINGS NOTED. IN THE RIGHT

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 APPROXIMATELY TWO WEEKS AFTER COMPLETION OF A DA VINCI SI HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED DURING A POST-SURGICAL CHECK-UP THAT THE PATIENT DEVELOPED ERYTHEMA AT TWO OF THE PORT SITE INCISIONS. THE AFFECTED PORT SITES WERE LOCATED AT THE UPPER LEFT AND UPPER RIGHT QUADRANTS. REPORTEDLY, A PK DISSECTOR INSTRUMENT WAS INSTALLED IN THE UPPER LEFT QUADRANT PORT SITE AND A MONOPOLAR CURVED SHEARS (MCS) INSTRUMENT WAS INSTALLED IN THE UPPER RIGHT QUADRANT 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 MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE INFORMATION ALLEGES THAT DURING THE SURGICAL PROCEDURE, THE PATIENT'S SIGMOID COLON WAS DAMAGED PER THE ON (B)(6) 2013, PER THE INFORMATION RECEIVED. THE PATIENT VISITED THE HOSPITAL EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND EXPLORATORY LAPAROTOMY ON (B)(6) 2013 TO REPAIR DAMAGE TO THE SIGMOID COLON. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON (B)(6) 2013 THE PATIENT RETURNED TO THE HOSPITAL WITH EXCESSIVE SWELLING TO HER LEGS. HER PHYSICIANS REPORTEDLY SUSPECTED DEEP VEIN THROMBUS; HOWEVER, THAT WAS RULED OUT AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2013 THE PATIENT WAS ADMITTED INTO THE HOSPITAL WITH A C-DIFF INFECTION. 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 SI HYSTERECTOMY PROCEDURE, THE PATIENT'S URETER WAS DAMAGED. DURING REPAIR OF THE PATIENT'S URETER BY THE SITE'S UROLOGIST, THE UROLOGIST NOTED THAT THE JAW ON THE ENDOWRIST INSTRUMENT INSTALLED ON THE PATIENT SIDE MANIPULATOR (PSM) ARM WAS NOT ARTICULATING CORRECTLY. REPORTEDLY, THE SITE REPLACED THE INSTRUMENTS MULTIPLE TIMES AND REPLACED THE DRAPE; HOWEVER, THE ISSUE PERSISTED. THE SITE REPORTED THAT DURING INSTALLATION OF THE STERILE ADAPTER ONTO THE PSM, IT WAS NOTED THAT THE STERILE ADAPTER DID NOT APPEAR TO ENGAGE FULLY WITH THE PSM. UNABLE TO RESOLVE THE ISSUE, THE SURGEONS MADE THE DECISION TO REPAIR PATIENT'S URETER AND COMPLETE THE SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES.

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 SUCCESSFUL ESOPHAGECTOMY PROCEDURE, THE PATIENT WAS DOING WELL FOR EIGHT DAYS POST SURGERY, ACCORDING TO THE SURGEON. HOWEVER, THE PATIENT LEAKED ON THE EVENING OF THE EIGHTH DAY AND HAD TO GO TO THE EMERGENCY ROOM. REPORTEDLY, THE ANASTAMOSIS HAD TO BE TAKEN APART AND CERVICAL ESOPHAGECTOMY HAD TO BE PERFORMED INSTEAD, ENDING THE ESOPHAGUS AS AN OSTOMY AT THE NECK. NO FURTHER INFORMATION WAS PROVIDED 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 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON HAD ARTICULATION ISSUES WITH ONE OF THE PATIENT SIDE MANIPULATORS (PSM). THE STAFF REPORTEDLY RE-SEATED THE INSTRUMENT AND EVENTUALLY REPLACED THE DRAPE ON THAT PSM. HOWEVER, THE ISSUE PERSISTED INTERMITTENTLY. IT WAS STATED THAT THE ARM JUMPED, CAUSING THE INSTRUMENT HELD IN THAT PSM TO STAB AN ARTERY, WHICH LED TO SOME BLEEDING THAT THE SURGEON WAS ABLE TO CONTROL WITHOUT CONVERTING THE PROCEDURE. THE SCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY.

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 INITIALLY REPORTED THAT DURING A DA VINCI SI TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE BIPOLAR INSTRUMENT FIRED UNINTENTIONALLY DURING A PROCEDURE ACCORDING TO THE INFORMATION PROVIDED TO THE CLINICAL SALES REPRESENTATIVE (CSR), THE CUSTOMER ALLEGED THAT WHILE THEY WERE INSTALLING THE BIPOLAR INSTRUMENT TO THE DAVINCI ROBOT SYSTEM, AS THEY CONNECTED THE BIPOLAR INSTRUMENT CABLE TO THE VALLEYLAB GENERATOR, THE ELECTROSURGICAL UNIT (ESU) MADE A FIRING TONE AND THE BIPOLAR INSTRUMENT FIRED. THE INSTRUMENT TIP DID TOUCH THE PATIENT'S UTERUS (WHICH WAS EVENTUALLY REMOVED). ACCORDING TO THE INFORMATION PROVIDED TO THE CSR, THE CUSTOMER WAS ABLE TO SUCCESSFULLY COMPLETE THE CASE PLUS TWO ADDITIONAL CASES USING THE SAME GENERATOR WITH NO FURTHER INCIDENTS.

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 S HYSTERECTOMY PROCEDURE, A BOWEL PERFORATION WAS DISCOVERED POST SURGERY. THE SURGEON REPORTEDLY STATED THAT THE INJURY MAY HAVE OCCURRED WHILE INSERTING THE CAMERA CANNULA, OR WHEN CUTTING THROUGH THE FASCIA. NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENT(S) AND/OR ACCESSORIES WERE REPORTED DURING THE COURSE OF THIS PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED ALLOGRAFT COLPOPEXY, CYSTOCELE REPAIR, TVT MID URETHRAL TAPE WITH CYSTOSCOPY FOR TOTAL VAGINAL PROLAPSE WITH SEVERE CYSTOCELE, RECTOCELE AND ENTEROCELE AND URINARY INCONTINENCE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. PER THE OPERATIVE REPORT, SURGICAL FINDINGS INCLUDED SIGNIFICANT ADHESIONS OF LOOPS OF SMALL BOWEL TO THE PELVIS, CUL-DE-SAC IN THE MIDLINE, AND RIGHT SIDE WALL. THE SURGEON PERFORMED THE LYSIS OF ADHESIONS ROBOTICALLY AND THE SACRAL COLPOPEXY AND TVT PORTIONS OF THE SURGERY. ANOTHER SURGEON PERFORMED THE RECTOCELE AND ENTEROCELE REPAIR PROCEDURES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. ON (B)(6) 2013, PER A UROGYNECOLOGY OFFICE NOTE, THE FOLLOWING WAS NOTED, FEELING SORE IN ABD, REPORTED 'PURPLE LINES' NO EVIDENCE OF INFECTION, AND NO ANTIBIOTICS. IN ADDITION, THE PATIENT WAS USING IBUPROFEN FOR PAIN. THERE WAS NO OXYCODONE USE. TH