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 HYSTERECTOMY PROCEDURE, AN EMERGENCY CONVERSION TO OPEN SURGERY DUE TO LACK OF VISUALIZATION HAD OCCURRED. THE PATIENT EXPIRED DURING THE OPEN PROCEDURE. THERE WERE NO REPORTS OF ANY SYSTEM, INSTRUMENT(S) AND/OR ACCESSORY(IES) MALFUNCTION DURING THE COURSE OF THE 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: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGED TO HAVE INJURIES INCLUDING A THERMAL INJURY TO THE URETER. 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DAMAGED HER BLADDER, NO FEELING FROM HER BELLY BUTTON DOWN TO LEFT QUADRANT INSIDE INNER THIGH, INCONTINENCE, SEVERE PAIN, BLADDER WAS NICKED 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: THE PT IS A (B)(6) FEMALE ADMITTED TO (B)(6) MEDICAL CENTER ON (B)(6) 2012, FOR A SCHEDULED SURGERY. THE PT HAD BEEN DIAGNOSED WITH A RETROPERITONEAL LYMPHADENOPATHY. THE PLANNED SURGERY WAS A ROBOTIC ASSISTED PERIPANCREATIC LYMPH NODE EXCISION. DURING THE PROCEDURE TO EXCISE THE LYMPH NODE THE SURGEON NOTICED THAT THE CAUTERY HOOK WAS MALFUNCTIONING. THE MALFUNCTION DEVICE WAS REMOVED. UPON REMOVAL OF THE CAUTERY HOOK, IT WAS NOTED THAT PART OF THE PLASTIC CASING AROUND THE PULLEY OF THE HOOK WAS BROKEN OFF. THE SURGICAL TEAM IMMEDIATELY BEGAN EXTENSIVE SEARCH IN THE AREA OF THE LYMPH NODE DISSECTION, UNDERNEATH THE LIVER AND AROUND THE PORTA HEPATIS, BUT DID NOT SEE ANY EVIDENCE OF THE BROKEN PLASTIC CASING. SEVERAL ATTEMPTS WERE MADE TO LOCATE THE MISSING FRAGMENT INCLUDING CREATING A HAND PORT IN THE UPPER MIDABDOMEN. A FLAT PLATE KUB WAS TAKEN. THE TEAM WAS UNABLE TO LOCATE THE MISSING FRAGMENT. THE PT REMAINED STABLE THROUGHOUT THE SURGERY AND AT THE CONCLUSION OF THE PROCEDURE WAS TAKEN BACK TO RECOVERY IN STABLE CONDITION.

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 AUGUST 16TH, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WITH HISTORY OF IRREGULAR MENSTRUAL PERIODS AND AN ENLARGED FIBROID UTERUS WHO EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY. ACCORDING TO THE OPERATIVE REPORT FOR (B)(6) 2012, DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGECTOMY WAS PERFORMED FOLLOWED BY CYSTOSCOPY. INDIGO CARMINE WAS ADMINISTERED INTRAVENOUSLY; BLUE DYE WAS VISUALIZED COMING FROM THE RIGHT URETERAL ORIFICE BUT NOT FROM THE LEFT. THE UROLOGIST WAS CONSULTED AND HE WAS ABLE TO PASS A DOUBLE-J STENT UP THE LEFT URETER. THE STENT WAS INTENDED TO BE IN PLACE FOR SIX WEEKS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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. ON (B)(6) 2013 THE PATIENT UNDERWENT A CYSTOSCOPY, LEFT DOUBLE-J STENT REMOVAL, LEFT RETROGRADE PYELOGRAM, RIGHT RETROGRADE PYELOGRAM, LEFT DISTAL SEMIRIGID URETEROSCOPY, BALLO

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 KIDNEY SURGERY ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INTERNAL BLEEDING AND ARTERY WAS CUT BY MISTAKE, CONSTANT AND EXTREME 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 AFTER COMPLETION OF GENERAL SURGICAL PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI S SURGICAL SYSTEM, THE SURGEON WAS CONCERNED THAT HE MAY HAVE HIT THE PATIENT'S 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: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUFFERED A PERFORATED COLON AND EXPERIENCED INTENSE PAIN AND STOOL DRAINAGE FROM THE SURGICAL SITE, DEVELOPED A SEVERE INFECTION, AND UNDERWENT AN EMERGENCY REPAIR, DEBRIDEMENT, AND ABDOMINAL WASHOUT PROCEDURE TWO DAYS LATER. THE LEGAL COMPLAINT ALSO INDICATED THAT THE PATIENT HAD CONSIDERABLE PAIN, DISABILITY, CONVALESCENCE AND DISFIGUREMENT THEREAFTER.

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 HERNIA REPAIR ON (B)(6) 2012. 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 AN ESOPHAGEAL RUPTURE RESULTING IN 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: ON (B)(6) 2013, INTUITIVE SURGICAL, INC. RECEIVED VOLUNTARY REPORT MW5030296 WITH THE FOLLOWING DESCRIPTION: MD PERFORMED A ROUTINE HYSTERECTOMY USING A DA VINCI ROBOT AT XX IN XX. HE DAMAGED (CUT) MY LEFT URETER CAUSING A FISTULA. DR XX DIDN'T REALIZE IT AT THE TIME OF SURGERY AND I WAS RELEASED. THIS FISTULA CAUSED MY KIDNEY TO MALFUNCTION REQUIRING EMERGENCY HOSPITALIZATION. IT WAS STILL UNDIAGNOSED WHILE IN THE HOSPITAL. ON XX 2013 DR XX ORDERED A CT SCAN TO DETERMINE THE CAUSE OF THE FISTULA. I HAD OUTPATIENT SURGERY ON XX 2013 AND A NEPHROSTOM TUBE WAS INSERTED INTO MY KIDNEY. ON XX 2013 DR XX PERFORMED ANOTHER OUTPATIENT SURGERY AND PUT A DOUBLE J STENT INTO MY DAMAGED URETER WHICH WAS IN FOR 6 WEEKS.

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 HYSTERECTOMY FOR MENORRHAGIA, DYSMENORRHEA, AND PELVIC PAIN ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. OTHER CONSULTANTS NOTES ARE INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION SPECIFICALLY, A NARROWING OF THE RIGHT URETER POST PROCEDURE REQUIRING AN INTRA-OPERATIVE CONSULTATION FROM A UROLOGIST WHO WAS ABLE TO PASS A GLIDEWIRE AND A RIGHT URETERAL STENT PAST THE POINT OF NARROWING INTO THE RIGHT KIDNEY. THE PATIENT THEN HAD TO LEAVE THE STENT IN PLACE AND RETURN AT 6 WEEKS TO HAVE IT REMOVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012.

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 WAS USING THE DAVINCI SYSTEM FOR A HYSTERECTOMY ON A (B)(6). THE PRECISE BIPOLAR INSTRUMENT WAS INSERTED AND WHEN I GRASPED TISSUE THE CURRENT ACTIVATED WITHOUT THE FOOT PEDAL BEING PRESSED. THE AUDIBLE POWER SOUND WAS HEARD AND THE GRASPED TISSUE WHICH FORTUNATELY WAS A FALLOPIAN TUBE WAS CAUTERIZED. THE ENTIRE CREW IN THE OPERATING ROOM WITNESSED THIS EVENT. I THEN GRASPED THE UTERUS IN SEVERAL LOCATIONS AND THE INSTRUMENT AGAIN TRANSMITTED ENERGY WITH THE GRASPING OF TISSUE WITHOUT USE OF THE FOOT PEDAL. THE DEVICE WAS REMOVED AND THE PK DEVICE INSERTED, TESTED AND THE CASE PROCEEDED WITHOUT INCIDENT. EXAM OF THE BOWEL AND SURROUNDING TISSUE DISCLOSED NO INJURY AND THE PT WAS DISCHARGED THE NEXT MORNING. THIS ONLY OCCURRED 2 DAYS AGO HOWEVER SO POTENTIAL FOR DELAYED INJURY STILL EXISTS. A SIMILAR EVENT HAD OCCURRED 2 MONTHS AGO USING A FENESTRATED BIPOLAR DEVICE ON THE SAME SYSTEM AND GENERATOR WHERE UPON INSERTION OF THE INSTRUMENT ENERGY WAS IMMEDIATELY DELIVERED PRIOR TO FOOT PEDAL ACTIVATION. THE DEVICE WAS DISCONNECTED, REINSERTED AND THE PROBLEM DID NOT RECUR ON THE SECOND ATTEMPT.

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 PROCEDURE ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT WAS ALLEGED TO HAVE SUSTAINED A THERMAL BURN TO A URETER WHICH LED TO EXTRAVASATION OF THE URETER. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND DID NOT SEE ANY DOCUMENTATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER ALSO STATED THAT THERE WERE NO REPORTS TO THE RISK MANAGEMENT DEPARTMENT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON HER REVIEW OF THE OPERATIVE REPORT, THE RISK MANAGER NOTED A STATEMENT THAT THE UTERINE ARTERY WAS BURNED OUT TOWARD THAT AREA AND WAS THEN EXCISED BY THE SURGEON. THE RISK MANAGER WAS UNABLE TO PROVIDE CLARIFICATION AS TO WHAT WAS MEANT BY THE UTERINE ARTERY WAS BURNED OUT.

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 INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND CYSTOSCOPY ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF LARGE UTERINE FIBROID. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. AT THE END OF THE SURGICAL PROCEDURE, THE ENTIRE SURGICAL AREA WAS INSPECTED FOR HEMOSTASIS AND THERE WAS NO EVIDENCE OF BLEEDING. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. REPORTEDLY, THE PATIENT RECEIVED A BLOOD TRANSFUSION POST-OPERATIVELY. ON (B)(6) 2012 THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF VAGINAL BLEEDING AND CRAMPING. A PELVIC EXAMINATION FOUND THAT THE PATIENT WAS BLEEDING FROM THE VAGINAL CUFF APEX. THE AFFECTED AREA WAS SUTURED AND THE BLEEDING WAS NOTED TO HAVE CEASED AFTER THE REPAIR. THE PATIENT ALSO REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED FROM THE HOSPI

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 SI PROSTATECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE INJURIES INCLUDING A BOWEL PERFORATION REQUIRING COLECTOMY. 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DAVINCI ROBOTIC BILATERAL SALPINGO-OOPHORECTOMY FOR BILATERAL DERMOID TUMORS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. 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. THE PATIENT HAD PREVIOUSLY UNDERGONE ROBOTIC HYSTERECTOMY 13 MONTHS PRIOR AND NOW PELVIC PAIN PERSISTS. ON (B)(6) 2012 THE PATIENT UNDERWENT BILATERAL SALPINGO-OOPHORECTOMY. PER OPERATIVE REPORT, PK DISSECTING FORCEPS AND MONOPOLAR SCISSORS WERE USED. THE PATIENT WAS DISCHARGED HOME NEXT DAY IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT WAS READMITTED FOR ABRUPT FEVER AND CHILLS. SONOGRAM NOTED SMALL AMOUNT FLUID IN PELVIS. PATIENT UNDERWENT CYSTOSCOPY WITH ATTEMPTED RIGHT URETERAL STENT PLACEMENT. URINOMA WAS DISCOVERED. THE PROCEDURE WAS ABORTED SINCE SURGEON WAS UNABLE TO PLACE STENT. NEPHROSTOMY TUBE WAS PLACED. ON (B)(6) 2013, THE PATIENT SUBSEQUENTLY UNDERWENT RIGHT URETERAL RE-IMPLANT WITH PSOAS HITCH PROCEDURE THROUGH AN OPEN LAPAROTOMY APPROACH. THE PAT

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT EXPIRED APPROXIMATELY FOUR WEEKS AFTER AN ESOPHAGECTOMY PROCEDURE WAS PERFORMED. THE ROBOTICALLY-ASSISTED SURGERY WAS CONVERTED TO OPEN SURGICAL TECHNIQUES, AS IT WAS STATED TO HAVE BEEN DIFFICULT FOR A NUMBER OF REASONS, ACCORDING TO THE SURGEON. THE COMPANY REPRESENTATIVE WAS INFORMED THAT THE PATIENT WAS DISCHARGED THREE WEEKS AFTER THE PROCEDURE FOR REHABILITATION. THE PATIENT THEN DIED A WEEK LATER OF WHAT THE HOSPITAL STAFF BELIEVES TO BE DUE TO A PULMONARY EMBOLISM/OTHER CARDIORESPIRATORY RELATED EVENT. NO FURTHER INFORMATION WAS 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI THROAT SURGICAL PROCEDURE FOR SLEEP APNEA ON (B)(6) 2012. THE PATIENT REPORTEDLY DEVELOPED COGNITIVE ISSUES, WORSENED DEPRESSION, PROBLEMS WITH EATING AND CHOKING, AND FOOD TASTED TASTELESS FOLLOWING THE SURGICAL PROCEDURE. 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 WHILE UNDOCKING AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED CHARRING AT ONE OF THE PORT INCISION SITES. THE SURGEON EXCISED A SMALL AREA OF THE AFFECTED PORT SITE, SUTURE CLOSED THE INCISION AND APPLIED A DRY DRESSING. THE EXCISED SAMPLE WAS SENT TO THE HOSPITAL'S PATHOLOGY DEPARTMENT TO BE ANALYZED. THE ROBOTICS COORDINATOR PRESENT DURING THE SURGICAL PROCEDURE INDICATED THAT THERE WAS NO HARM TO THE PATIENT DURING THE SURGICAL PROCEDURE AND THE SYSTEM DID NOT FAULT DURING THE PLANNED 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 HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING WITH LARGE UTERINE FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND THE EXPLORATORY LAPAROTOMY AND ICU DISCHARGE SUMMARY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL COAGULATION AND DIVISION OF THE ROUND LIGAMENTS, UTERO-OVARIAN LIGAMENTS, BROAD LIGAMENTS, UTEROSACRAL LIGAMENTS AND UTERINE VESSELS. THE COLPOTOMY WAS COMPLETED, BUT THE UTERUS WAS TOO LARGE TO DELIVER VAGINALLY, SO IT WAS MORCELLATED WITH A HAND HELD MORCELLATOR UNTIL SMALL ENOUGH TO DELIVER. THE VAGINAL CUFF WAS CLOSED WITH V-LOC SUTURE AND ADDITIONAL MATERIAL USED TO SECURE ADEQUATE HEMOSTASIS. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2012, PATIENT PRESENTED WITH A HISTORY OF LOWER ABDOMINAL DISCOMFORT, NAUSEA AND CONSTIPATION. CT IMAGING SHOWED EXTENSIVE COMPLEX FLUID COLLECTION IN PELVIS AND PERICOLIC GUTTERS CONSISTENT WITH HEMATOMA OR ABSCESS. IN THE ED DARK PURULENT MATERIAL WAS DR

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 PARTIAL HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: RIGHT URETER WAS CUT, URINE LEAKAGE INTO ABDOMINAL CAVITY, ABDOMINAL PAIN, AND STENTS IN HOLE.

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 SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF IRREGULAR BLEEDING AND PELVIC PAIN. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS. AFTER THE PATIENT'S UTERUS, OVARIES, AND TUBES WERE REMOVED THROUGH THE VAGINA, THE VAGINAL CUFF WAS CLOSED WITH SUTURES AND CAREFUL INSPECTION REVEALED EXCELLENT HEMOSTASIS OF ALL PEDICLES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, AND VOMITING. THE PATIENT WAS SENT HOME THE SAME DAY AFTER NO SIGNS OF ACUTE INTRA-ABDOMINAL OR PELVIC ABSCESSES WERE FOUND. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN THE ER FOR REPORTED COMPLAINTS OF VAGINAL BLEEDING, NAUSEA, AND VOMITING. A CT SCAN PERFORMED ON THE PA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLADDER WON'T STOP LEAKING, HAS HERNIA, 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 DISCOVERY ACTIVITY, ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE. ISI WAS PROVIDED WITH A COPY OF THE HOSPITAL'S RISK OCCURRENCE REPORT FROM THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE RISK OCCURRENCE REPORT INDICATED THAT DURING THE SURGICAL PROCEDURE, THE PATIENT SUSTAINED A RIGHT URETER INJURY. THE SITE'S UROLOGIST ANASTOMOSED THE PATIENT'S URETER TO REPAIR THE DAMAGE USING THE DA VINCI SURGICAL SYSTEM. THE PATIENT ALSO UNDERWENT A CYSTOSCOPY PROCEDURE, AND A RIGHT URETERAL STENT PLACEMENT PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL RADIOLOGY AND OPERATIVE REPORTS. 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. ON (B)(6) 2012, THE PATIENT WAS ADMITTED WITH NAUSEA, VOMITING, AND AN ILEUS. SHE HAD MULTIPLE DAYS OF FEVER AND WAS STARTED ON I.V. ANTIBIOTICS. ON (B)(6) 2012, SHE HAD A CT SCAN, WHICH NOTED A PELVIC FLUID COLLECTION AND ABSCESS. ON (B)(6) 2012, HER PELVIC ABSCESS WAS DRAINED. SHE THEN HAD DECREASED URINE OUTPUT AND THE DRAINING PELVIC FLUID WAS THOUGHT TO BE URINE (URINOMA). SUBSEQUENTLY, BILATERAL NEPHROSTOMY TUBES WERE PLACED AND THE PATIENT REMAINED IN THE HOSPITAL ON I.V. ANTIBIOTICS. THE PATIENT SLOWLY IMPROVED WITH A RESOLVED ILEUS. ON (B)(6) 2012, A RETROGRADE IVP SHOWED A SMALLER, BUT PERSISTENT, CYSTOTOMY. OVER THE NEXT WEEK, THE NEPHROSTOMY TUBES WERE REMOVED AND THE PATIENT WAS EVENTUALLY DISCHARGED. HAD PROLONGED URINAR

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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S LYSIS OF ADHESIONS, BILATERAL SALPINGO-OOPHORECTOMY, APPENDECTOMY, CYSTOSCOPY AND CERVICAL STRUMECTOMY WHICH WERE PERFORMED ON (B)(6) 2012. PER THE OPERATIVE REPORTS, DENSE ABDOMINAL PELVIC ADHESIONS, CONSISTENT WITH THE PATIENT'S HISTORY OF PRIOR SURGERIES, LAPAROSCOPIC BANDING AND ENDOMETRIOSIS. THERE WAS A DENSE ADHESION SURROUNDING THE LAP BAND FROM THE OMENTUM AND THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL REQUIRING APPROXIMATELY AN HOUR AND A HALF OF ADHESIOLYSIS TO NORMALIZE THE ANATOMY. THE SAME WAS FOUND IN THE PELVIS WITH THE OVARIES. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE OP REPORT DID NOT ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WERE NO ANOMALIES NOTED. PER THE INFORMATION IN THE OP REPORT, THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURES WELL. THE SURGEON'S POST-OPERATIVE DIAGNOSIS WERE PELVIC ADHESIVE DISEASE, ABDOMINAL ADHESI

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 ROBOTIC SIGMOID COLON RESECTION FOR SIGMOID DIVERTICULITIS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. 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 ALTHOUGH ONE IS IMPLIED BY LATER EVENTS SURROUNDING INJURY TO SPLEEN. ON (B)(6) 20112 THE PATIENT UNDERWENT A ROBOTIC SIGMOID COLON RESECTION. NOTED SOME ISSUES WITH ROBOTIC INSTRUMENTATION AT SOME POINTS, AND HAD TO CHANGE UP OPERATIVE TECHNIQUE. ON (B)(6) 2012, THE PATIENT WAS TAKEN BACK TO SURGERY EMERGENTLY FOR POST OPERATIVE HEMORRHAGE. NOTED SPLENIC INJURY AND HAD TO REMOVE THE SPLEEN. RECEIVED MASSIVE BLOOD TRANSFUSIONS. PATIENT WAS DISCHARGED HOME ON (B)(6) 2012 AND WAS IN STABLE CONDITION. PATIENT WAS ADVISED THAT THEIR ACTIVITY BE LIMITED FOR 6 WEEKS.

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 DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS UNDOCKING THE SYSTEM FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUFFERED A BOWEL TEAR DURING THE PROCEDURE. ACCORDING TO THE INFORMATION PROVIDED BY INITIAL REPORTED CLINICAL SALES REPRESENTATIVE, THE TIPS OF THE PROGRASP FORCEPS INSTRUMENT WERE NOT USED TO GRAB THE BOWEL, BUT THE SHAFT OF THE INSTRUMENT WAS USED TO RETRACT THE 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: 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. THE INTENDED 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: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING THE MEDICAL RECORDS AND OPERATIVE REPORTS OF A PATIENT WHO UNDERWENT ROBOTIC PARTIAL NEPHRECTOMY ON (B)(6) 2012. THE PROCEDURE WAS WELL TOLERATED BY THE PATIENT. THE PATIENT DID WELL FOR THE FIRST 6 HOURS AFTER THE DA VINCI SURGICAL PROCEDURE; HOWEVER, THEN BEGAN TO BE TACHYCARDIC AND WAS HAVING WORSENING PAIN AND WAS GIVEN SEVERAL DOSES OF NARCOTIC DURING THIS TIME. PATIENT'S INITIAL HEMATOCRIT WAS 31; HOWEVER, A FEW HOURS LATER THE PATIENT WAS FOUND TO BE UNRESPONSIVE AND CODE WAS CALLED. THE PATIENT WAS INTUBATED AT THIS TIME AND WAS GIVEN NARCAN WHICH MADE HER MORE ALERT AND WAS RESUSCITATED FAIRLY QUICKLY. THE PATIENT WAS ALSO NOTED TO HAVE A COAGULOPATHY WITH ELEVATED INR AND A LOW PLATELET COUNT. THE PATIENT WAS CONTINUED WITH RESUSCITATION WITH TRANSFUSIONS AND REPLACEMENT OF CLOTTING FACTORS AND PLATELETS, AND SHE WAS FAIRLY STABLE AFTER THE FIRST TWO TRANSFUSIONS. CT SCAN REVEALED THAT THERE WAS INTRAPERITONEAL BLOOD AND BLOOD IN THE LEFT LOWER QUADRANT CONSISTENT WITH A BLEED FROM THE KIDNEY. THE PATIENT SLOWLY IMPROVED AFTER HER CLOTTING FACTORS WERE REPLACED. SHE WAS ALSO

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 AFTER THE CANNULA CAME INTO CONTACT WITH THE PATIENT'S LIP AT THE BEGINNING OF THE TONGUE BASE RESECTION PROCEDURE. AT THE TIME OF THIS INCIDENT, THE SURGEON REPORTEDLY UTILIZED THE 5 MM MARYLAND DISSECTOR AND 5 MM MONOPOLAR CAUTERY INSTRUMENTS CONNECTED TO THE SECONDARY GROUNDING PAD, IN CONJUNCTION WITH THE RECOMMENDED FLARED CANNULA. TO PREVENT FURTHER HARM TO THE PATIENT, INTRAOPERATIVE REPOSITIONING OF THE DA VINCI SYSTEM WAS CONDUCTED, SUCH THAT THE CANNULA WAS PULLED WELL ABOVE THE LEVEL OF THE PATIENT'S LIP. THE INTENDED ROBOTIC PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CONVERSION.

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 PLANNED DAVINCI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC WASHINGS, CYSTOSCOPY FOR A PREOPERATIVE DIAGNOSIS OF ENDOMETRIAL HYPERPLASIA WITH ATYPIA AND FIBROID UTERUS ON (B)(6) 2012. IN ADDITION, PATIENT HAD PRIMARY URETERAL REANASTOMOSIS TO REPAIR AN UNINTENTIONAL INTRAOPERATIVE URETERAL TRANSECTION AND BILATERAL PELVIC LYMPHNODE DISSECTION SECONDARY TO AN INTRAOPERATIVE DIAGNOSIS OF ENDOMETRIAL ADENOCARCINOMA. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY PROCEDURE AND THE TWO SUBSEQUENT PROCEDURES. NO MEDICAL HISTORY OR DISCHARGE SUMMARIES WERE PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE SURGERY TOOK APPROXIMATELY 11 HOURS. INITIAL DIFFICULTY WAS REPORTED WITH THE FIBROUS 16 WEEK SIZE UTERUS, NECESSITATING PLACEMENT OF THE CAMERA PORT A HANDS BREADTH ABOVE THE UMBILICUS. BLEEDING WAS NOTED UPON ENTRY, AND EXTENSIVE DISSECTION REQUIRED WITH LARGE FIBROID IN THE RIGHT BROAD LIGAMENT CAUSING ANATOMICAL DISTORTION. THE HYSTERECTOMY PORTION WAS CARRIED OUT IN 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 AND MEDICAL RECORDS REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR PROSTATE CANCER. THE PATIENT REPORTEDLY DEVELOPED STRESS INCONTINENCE, NOCTURIA, URINARY FREQUENCY, ERECTILE DYSFUNCTION, AND POSSIBLY URETHRAL SPHINCTER FOLLOWING THE DA VINCI SURGERY. THE PATIENT'S MEDICAL RECORDS DATED (B)(6) 2012, RELATED TO THE PATIENT'S PRE-OPERATIVE CARE WERE PROVIDED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS SEEN BY A MEDICAL ONCOLOGIST IN (B)(6) 2012. DUE TO A RECENT RISE IN PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS, THE ONCOLOGIST DISCUSSED CLOSE VIGILANT OBSERVATION VS. DEFINITIVE TREATMENTS SUCH AS SURGICAL OPTION OR RADIATION THERAPY. HE WAS INFORMED OF THE POTENTIAL MORBIDITIES ASSOCIATED WITH DEFINITIVE TREATMENT AND MOST NOTABLY WILL AFFECT HIS ERECTILE FUNCTION. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY DOCUMENT, THE PATIENT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012, WITH NO ISSUES AND COMPLICATIONS AND WAS DISCHARGED ON (B)(6) 2012. THE DA VINCI OPERATIVE REPORT WAS NOT PROVIDED. ADDITIONAL MEDICAL RECORDS DATED (B)(6) 2013, RELATED TO THE PATIENT'

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 NEPHRECTOMY PROCEDURE AND A UMBILICAL HERNIORRHAPHY ON (B)(6) 2012 FOR A LEFT RENAL NEOPLASM AND AN UMBILICAL HERNIA. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES AS A RESULT OF UNDERGOING THE DA VINCI SURGICAL PROCEDURE WHICH RESULTED WITH HIS DEATH ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. PER THE OPERATIVE REPORT, THE FOLLOWING WAS NOTED AFTER DISSECTION WAS PERFORMED, AT THIS POINT, IT WAS DECIDED TO PROCEED WITH DIVISION OF THE RENAL ARTERY AND WITH ELEVATION OF THE SUTURE, THE ARTERY WAS CUT BETWEEN THE TWO CLIPS, BUT ON ELEVATION BLEEDING DEVELOPED POSTERIORLY, WHICH WAS CONTROLLED INITIALLY WITH THE MARYLAND BIPOLAR IN NON COAGULATION MODE AND ATTEMPTS WERE MADE TO PLACE A SINGLE CLIP IN THE MAIN RENAL ARTERY HOWEVER, THIS WOULD NOT HOLD AND BLEEDING IMMEDIATELY ENSUED. THE PATIENT WAS URGENTLY CONVERTED TO AN OPEN THROUGH A LEFT PARAMEDIAN INCISION AND THE AORTA WAS CONTROLLED WITH DIGITAL PRESSURE. APPROXIMATELY 900 CC OF BLOOD WAS LOST DURING THIS RAPID CONVERSION. IT WAS NOTED THAT THE LEFT RE

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 LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGED THAT THE DA VINCI SYSTEM DAMAGED HIS BOWEL RESULTING IN SEVERE INFECTION AND OTHER COMPLICATIONS REQUIRING SUBSEQUENT HOSPITALIZATIONS AND MULTIPLE SURGICAL PROCEDURES AND/OR 'WASHOUTS'. THE LEGAL COMPLAINT ALSO ALLEGED THAT THE PATIENT ULTIMATELY SUFFERED SEPTIC SHOCK, ABDOMINAL COMPARTMENT SYNDROME, RENAL FAILURE, ACIDOSIS, AND NUMBNESS IN THE HIPS AND KNEES, AMONG OTHER THINGS. IN ADDITION, THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT REMAINS SERIOUSLY INJURED AND CONTINUES TO SUFFER FROM CHRONIC PAIN, KIDNEY DISEASE, MEMORY AND COGNITIVE IMPAIRMENTS, AND OTHER SEVERE 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY FOR UTERINE BLEEDING AND FIBROIDS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT FOR THE PRIMARY SURGERY AND CYSTOSCOPY FOR A STENT PLACEMENT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, SPECIFICALLY A THERMAL BURN TO THE URETER. THE OPERATIVE REPORT STATES THAT THE PATIENT HAD SIGNIFICANT ADHESIONS FROM THE OMENTUM TO THE ABDOMINAL WALL, FROM THE COLON TO THE LEFT OVARIAN FOSSA, AND FROM THE SMALL BOWEL TO THE PARIETAL PERITONEUM. SHE ALSO HAD MULTIPLE UTERINE FIBROIDS AND ACTIVE ENDOMETRIOSIS IMPLANTS. THE PATIENT NEEDED SIGNIFICANT ADHESIOLYSIS THROUGHOUT THE PROCEDURE. BOTH URETERS WERE VISUALIZED AND CAREFULLY PRESERVED. IT WAS NOTED THAT DURING THE DISSECTION OF THE CERVIX FROM THE VAGINA, THERMAL INJURY OCCURRED TO THE URETER. A UROLOGIST CAME IN, PLACED A RETROGRADE DOUBLE-J STENT CYSTOSCOPICALLY AND DIRECTED THE SURGEON TO PLACE A SUTURE ON THE ANTERIOR W

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) 2012. 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 THERMAL INJURIES TO HER URETER AND BLADDER. 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 RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND REPAIR OF A CYSTOTOMY FOR MENORRHAGIA, DYSMENORRHEA, UTERINE LEIOMYOMA AND BILATERAL OVARIAN CYSTS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (B)(6) 2012, DISCHARGE SUMMARY (B)(6) 2012, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION (INADVERTENT CYSTOTOMY <1CM IN THE DOME OF THE BLADDER). INITIALLY, PLACEMENT OF A UTERINE MANIPULATOR, ESTABLISHMENT OF PNEUMOPERITONEUM WITH A VERESS NEEDLE, INSERTION OF 4 TROCARS, AND DOCKING OF THE ROBOT WERE PERFORMED. THE INFUNDIBULOPELVIC VESSELS WERE ISOLATED AWAY FROM THE URETERS AND CAUTERIZED WITH BIPOLAR CAUTERY. THE DISSECTION WAS EXTENDED DOWN THROUGH THE ROUND LIGAMENT. THE ANTERIOR LEAF OF THE BROAD LIGAMENT WAS THEN INCISED AND THE BLADDER REFLECTED AWAY. ON DISSECTION OF THE BLADDER FROM THE LOWER UTERINE SEGMENT, AN APPROXIMATELY 1 CM INADVERTENT CYSTO

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT INDICATE THAT THE PATIENT UNDERGOING THE DA VINCI HYSTERECTOMY PROCEDURE WAS A MALE PATIENT. THE LEGAL DOCUMENT ALLEGES THAT AS A RESULT OF THE DA VINCI PROCEDURE THE PATIENT SUBSEQUENTLY DIED. THE DATE OF DEATH WAS NOT PROVIDED TO INTUITIVE SURGICAL INC. (ISI). NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY 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: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013, INTUITIVE SURGICAL, INC.(ISI) RECEIVED INFORMATION INCLUDING THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 DUE TO RECURRENT CARCINOMA IN SITU OF THE CERVIX, FIBROIDS AND MENORRHAGIA. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE REPORT (OP) THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. ACCORDING TO THE OP REPORT, THE PATIENT HAD A PREVIOUS RIGHT SALPINGECTOMY FOR ECTOPIC PREGNANCY AND THERE WAS SOME SCAR TISSUE FROM THE RIGHT OVARY TO THE UTERUS. THE PATIENT'S UTERUS WAS FOUND TO BE TOO LARGE TO REMOVE VAGINALLY, WHICH REQUIRED THAT THE UTERUS/CERVIX BE MORCELLATED AND THEN REMOVED. INSPECTION OF THE PATIENT'S ABDOMEN FOUND THAT ALL OF THE SURGICAL SITES WERE HEMOSTATIC. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. THE MEDICAL RECORDS RECEIVED BY ISI WERE NOT COMPLETE. BASED ON THE LIMITED INFORMATION PROVIDED, THE MEDICAL RECORDS SHOWED THAT THE PATIENT UND

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 OPERATIVE LAPAROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL URETEROLYSIS, ENTEROLYSIS, BILATERAL PELVIC LYMPHADENECTOMIES AND CYSTOSCOPY FOR PELVIC MASS (RULE OUT OVARIAN CARCINOMA), PROBABLE ENDOMETRIAL CARCINOMA ON (B)(6) 2012. INTUITIVE SURGICAL, INC (ISI) WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: DEATH CERTIFICATE OF THE COUNTY OF SANTA CLARA OF (B)(6) 2012, DEATH SUMMARY OF (B)(6) 2012, LETTER TO CLEAR PATIENT FOR SURGERY OF (B)(6) 2012, AND A REPORT OF TRANSTHORACIC ECHOCARDIOGRAM OF (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. BASED ON THE OPERATIVE REPORT, INTRA-OPERATIVELY, AN EXTENSIVE RETROPERITONEAL FIBROSIS WAS FOUND. ALSO, THERE WAS EXTENSIVE TRUNCAL OBESITY. INTRA-ABDOMINALLY, THERE WERE EXTENSIVE AMOUNT OF PELVIC ADHESIONS, PARTICULARLY ALONG THE LEFT PELVIC SIDEWALL. THE OPERATIVE REPORT STATES THAT THIS PROCEDURE REQUIRED SUBSTANTIALLY INCRE

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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS NO ALLEGATION IN THE PATIENT'S OPERATIVE REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT WAS INJURED OR EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE PATIENT'S HISTORY AND PHYSICAL REPORT STATES THAT THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM ON (B)(6) 2012 COMPLAINING OF FEVER, SEVERE ABDOMINAL PAIN AND DISTENTION. A CT SCAN PERFORMED ON THE PATIENT REVEALED THAT THE PATIENT HAD DILATED LOOPS OF SMALL BOWEL, INTRAPERITONEAL AIR, ABDOMINAL AND PELVIC FREE FLUID AND SOME HIGH ATTENUATION WITHIN THE PELVIC FREE FLUID. FROM (B)(6) 2012 THROUGH (B)(6) 2012 THE PATIENT UNDERWENT SEVERAL TESTS, EXAMINATIONS AND TREATMENTS DUE TO HER CONDITION; HOWEVER, HER CONDITION DID NOT IMPROVE. REPORTEDLY, ON (B)(6) 2012 THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF AD

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 RECEIVED INFORMATION, INCLUDING AN ENCOUNTER REPORT AND AN OPERATIVE REPORT OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) PROCEDURE ON (B)(6) 2012. THIS LEGAL ALLEGATION INDICATES THAT THE PATIENT SUFFERED POST-OPERATIVE COMPLICATIONS DUE TO THE DA VINCI SI SYSTEM. THE ENCOUNTER REPORT INDICATES THAT THERE WERE NO COMPLICATIONS DURING THE SURGICAL PROCEDURE. THE OPERATIVE REPORT STATES THAT THERE WERE NO COMPLICATIONS DURING THIS SURGICAL PROCEDURE. THERE IS NO INFORMATION RELATING TO A DA VINCI SURGICAL SYSTEM, ACCESSORY OR INSTRUMENT MALFUNCTION. ON (B)(6) 2012, THE PATIENT WAS RE-ADMITTED WITH COMPLAINTS OF LOW BACK PAIN AND LOWER ABDOMINAL PAIN. CT SCAN OF ABDOMEN/ PELVIS SHOWED MODERATE TO SEVERE LEFT -SIDED HYDRONEPHROSIS WITH NO EVIDENCE OF ANY OBSTRUCTING STONE OR MASS. ON (B)(6) 2012 INTERVENTIONAL RADIOLOGY PLACED A PERCUTANEOUS LEFT SIDE URETERAL STENT WAS PLACED FOR MODERATE HYDRONEPHROSIS. THE STENT WAS REMOVED IN 2-13 AFTER RESOLUTION OF THE OBSTRUCTION. ACCORDING TO POST-OPERATIVE FOLLOW UP NOTES, DATED (B)(6) , THE PATIENT WAS RECOVERING WELL 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC WASHINGS AND LYSIS OF ADHESIONS FOR A PELVIC MASS, POLYCYSTIC OVARIAN SYNDROME, HISTORY OF ENDOMETRIOSIS WITH DYSFUNCTIONAL UTERINE BLEEDING AND CHRONIC PELVIC PAIN ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: FOLLOW-UP (FU) VISIT WITH HISTORY AND PHYSICAL (H&P) (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. INTRAOPERATIVELY, AN EXTENSIVE ADHESIVE DISEASE WAS OBSERVED WITH MOSTLY FILMY ADHESIONS INVOLVING THE SMALL BOWEL AND THE RIGHT TUBE AND OVARY, THE RECTOSIGMOID COLON AND THE POSTERIOR ASPECT OF THE UTERUS, AS WELL AS THE SMALL BOWEL AND THE FUNDUS OF THE UTERUS. THERE WERE SOME ADHESIONS FROM THE LEFT TUBE AND OVARY TO THE RECTOSIGMOID COLON AS WELL. THE CUL-DE-SAC HAD PREVIOUSLY BEEN OBLITERATED WITH ENDOMETRIOSIS AND HERE WAS STILL SCARRING AND NODULARITY ALONG THE UTEROSACRALS AND CUL

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 FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGED TO HAVE A BOWEL PERFORATION. NO FURTHER INFORMATION IS 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI TOTAL LAPAROSCOPIC HYSTERECTOMY, MCCALL CULDOPLASTY, CYSTOSCOPY WITH CATHETERIZATION OF L URETER ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP OPERATIVE NOTES FROM SUBSEQUENT SURGERIES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION NAMELY OBSTRUCTION OF THE LEFT URETER IMMEDIATELY AFTER SURGERY, HOWEVER A STENT WAS PLACED TO KEEP THIS URETER OPEN. SEE THE DESCRIPTION BELOW. SUBSEQUENT HOSPITALIZATION AND PROCEDURES 3 WEEKS LATER WERE PERFORMED WHEN THE RIGHT URETER APPEARED TO HAVE BEEN DAMAGED AS WELL. ULTIMATELY THE RIGHT URETER HAD TO BE REIMPLANTED. ON (B)(6) 2012, THE PATIENT UNDERWENT A VINCI LAPAROSCOPIC HYSTERECTOMY WITH RIGHT SALPINGECTOMY, MCCALL CULDOPLASTY, CYSTOSCOPY WITH CATHETERIZATION OF LEFT URETER. FINDINGS: UTERUS 9 WEEKS SIZE. EXCERPTS: INDIGO CARMINE WAS GIVEN INTRAVENOUSLY AND CYSTOSCOPY WAS PERFORMED. IN APPROXIMATELY 12 MINUTES, POST INDIGO CARMINE I

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 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY FOR CHRONIC PELVIC PAIN AND ENDOMETRIOSIS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: OUTPATIENT FOLLOW-UP REPORT (B)(6) 2013, HISTORY AND PHYSICAL REPORT (B)(6) 2013, OR-REPORT (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. THE UTERUS WAS MOBILIZED AND THE LATERAL LIGAMENTS TRANSECTED USING PK AND MONOPOLAR CAUTERY SCISSORS. THE BLADDER FLAP WAS MOBILIZED AND THE BLADDER REFLECTED INFERIORLY OFF THE UTERUS. A CIRCUMFERENTIAL INCISION WAS MADE AT THE VAGINAL APEX AND THE UTERUS DELIVERED THROUGH THE VAGINAL CUFF. THE VAGINAL CUFF WAS CLOSED WITH A RUNNING SUTURE USING A V-LOC SUTURE. (BLOOD LOSS: 100 CC) POSTOPERATIVELY, THE PATIENT DID WELL, BUT HAD MINIMAL DAILY SPOTTING FOR 1 MONTH. SILVER NITRATE WAS USED ON THE VAGINAL CUFF AND RELIEVED SYMPTOMS. SINCE SURGERY, THE PATIENT EXPERIENCED INTERMITTENT PELVIC PAIN. 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 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT SUSTAINED A BRACHIAL PLEXUS INJURY DUE TO HOW THE PATIENT WAS POSITIONED.

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 INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF MENOMETRORRHAGIA AND CERVICAL INTRAEPITHELIAL NEOPLASIA III. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT DATED (B)(4) 2012, DURING THE SURGICAL PROCEDURE THE SURGEON ENCOUNTERED MULTIPLE OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL AND BLADDER ADHESIONS TO THE ANTERIOR UTERUS, WHICH WERE DISSECTED VERY CAREFULLY. BASED ON THE INFORMATION INDICATED IN THE PATIENT'S OP REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. TOWARDS THE END OF THE PROCEDURE, INDIGO CARMINE WAS INJECTED AND BLUE URINE WAS NOTED, WITHOUT ANY EXTRAVASATION OF DYE IN THE PATIENT'S ABDOMEN. BOTH URETERS WERE THEN OBSERVED THROUGH THE LAPAROSCOPE WITH PERISTALSIS NOTED ON BOTH SIDES. THE PATIENT'S VAGINAL CUFF WAS CLOSED AND UPON COMPLETION OF THE CLOSURE, HEMOSTASIS WAS NOTED. 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 THE HYSTERECTOMY SURGERY MY BLADDER WAS DAMAGED. I WAS RELEASED FROM THE HOSPITAL BUT HAD TO RETURN ON (B)(6) 2012 WITH A SERIOUS BLOOD INFECTION AND VAGINAL DISCHARGE. I WAS ADMITTED FOR SEVEN DAYS. SURGERY PERFORMED BY (B)(6) AT (B)(6). I HAD A HYSTERECTOMY THAT WAS DONE USING THE DA VINCI ROBOTIC SYSTEM. THE SURGERY WAS SCHEDULED FOR ONE AND A HALF HOURS BUT WAS TWO HOURS AND FORTY FIVE MINUTES. A NEEDLE WAS MISPLACED AND COULD NOT BE RECOVERED UNTIL AN X-RAY WAS DONE TO FIND IT. IT WAS RELEASED THE NEXT DAY. ON (B)(6) 2012, I CALLED THE DOCTOR BECAUSE OF PAIN URINATING AND HEAVY VAGINAL DISCHARGE. A PRESCRIPTION WAS CALLED TO MY LOCAL PHARMACY BUT THE NEXT DAY I BECAME WORSE AND RETURNED TO THE HOSP.