da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PHARYNGECTOMY PROCEDURE, THE PATIENT ALLEGEDLY SUFFOCATED BY ASPIRATION FROM LIGHT BLEEDING. ON 09/21/2017 AND 10/02/2017, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE REGARDING THE REPORTED EVENT: THERE WAS NO REPORT OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT ALSO DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS. POST-OPERATIVELY, ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED EDEMA IN THE THROAT AND EXPERIENCED DYSPHAGIA. IN ADDITION, THE PATIENT ALLEGEDLY EXPERIENCED SUFFOCATION AFTER ASPIRATING BLOOD. AS A RESULT, THE PATIENT WAS ADMINISTERED ARTIFICIAL RESPIRATION AND WAS TAKEN TO THE ICU. NO ADDITIONAL MEDICAL INTERVENTION WAS ADMINISTERED IN THE ICU. THE SITE ALSO INDICATED THAT NO MEDICAL INTERVENTION WAS ADMINISTERED SPECIFICALLY FOR THE POST-OPERATIVE LIGHT BLEEDING. ON 10/02/2017, ISI RECEIVED INFORMATION INDICATING THAT THE PATIENT WAS CURRENTLY IN GOOD CONDITION AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT WAS MY SISTER (B)(6), DOB (B)(6) 1957, WHO HAD ELECTIVE SURGERY ON (B)(6) 2016 FOR A PARTIAL HYSTERECTOMY. THE SURGERY WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6), WITH A DA VINCI ROBOT. DURING THE PROCEDURE, HER BOWEL WAS PERFORATED THREE TIMES. THIS WAS UNDETECTED BY THE SURGEON OR THE MEDICAL STAFF. SHE WAS KEPT OVERNIGHT FOR OBSERVATION DUE TO PAIN ON (B)(6) 2016 AND DISCHARGED ON (B)(6) 2016. SHE LIVED ALONE AND WAS IN TOUCH FOR A WHILE WITH DISTANT RELATIVES. WHEN NOT HEARD FROM ON (B)(6) 2014 A FRIEND WAS CALLED TO DO A WELFARE CHECK ON HER. SHE WAS FOUND UNCONSCIOUS, BLUE IN COLOR, DELIRIOUS AND IN SEVERE RESPIRATORY DISTRESS FROM SEPTIC SHOCK. SHE WAS TRANSPORTED VIA AMBULANCE TO (B)(6) HOSPITAL IN (B)(6) WHERE SHE WAS DIAGNOSED WITH SEPTIC SHOCK AND PLACED INTO EMERGENCY SURGERY. SHE DIED AT APPROX 9:45PM ON SUNDAY (B)(6) 2016. THE (B)(6) MEDICAL EXAMINER REPORT STATES THE CAUSE OF DEATH WAS SEPTIC SHOCK FROM THREE PERFORATIONS OF THE BOWEL. THIS PROBLEM FROM MY RESEARCH HAPPENS IN LESS THAN 1/2 OF ONE PERCENT OF CASES THAT ARE DONE WITH NORMAL LAPAROSCOPIC SURGERY WITH NO ROBOT. IT IS MY UNDERSTANDING THAT IT HAPPENS A LOT MORE OFTEN WITH THE DA VINCI ROBOT AND IS UNDE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5064171 WITH THE FOLLOWING EVENT DESCRIPTION: PT WAS MY SISTER (B)(6), DOB (B)(6) 1957, WHO HAD ELECTIVE SURGERY ON (B)(6) 2016 FOR A PARTIAL HYSTERECTOMY. THE SURGERY PERFORMED AT (B)(6) HOSPITAL IN (B)(6), WITH A DA VINCI ROBOT. DURING THE PROCEDURE, HER BOWEL WAS PERFORATED THREE TIMES. THIS WAS UNDETECTED BY THE SURGEON OR THE MEDICAL STAFF. SHE WAS KEPT OVERNIGHT FOR OBSERVATION DUE TO PAIN ON (B)(6) 2016 AND DISCHARGED ON (B)(6) AND DISCHARGED ON (B)(6) 2016. SHE LIVED ALONE AND WAS IN TOUCH FOR A WHILE WITH DISTANT RELATIVES. WHEN NOT HEARD FROM ON (B)(6) 2014 A FRIEND WAS CALLED TO DO A WELFARE CHECK ON HER. SHE WAS FOUND UNCONSCIOUS, BLUE IN COLOR, DELIRIOUS AND IN SEVERE RESPIRATORY DISTRESS FROM SEPTIC SHOCK. SHE WAS TRANSPORTED VIA AMBULANCE TO (B)(6) HOSPITAL IN (B)(6) WHERE SHE WAS DIAGNOSED WITH SEPTIC SHOCK AND PLACED INTO EMERGENCY SURGERY. SHE DIED AT APPROX. 9:45 PM ON SUNDAY (B)(6) 2016. THE (B)(6) MEDICAL EXAMINER REPORT STATES THE CAUSE OF DEATH WAS SEPTIC SHOCK FROM THREE PERFORATIONS OF THE BOWEL. THIS PROBLEM FROM MY RESEARCH HAPPENS IN LESS THAN 1/2 OF ONE PERCENT OF CASES THAT

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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A PATIENT SUSTAINED AN INJURY TO THE LUNG AND AN INJURY TO THE LIVER. DETAILS REGARDING WHAT SPECIFIC TYPES OF INJURIES WERE SUSTAINED BY THE PATIENT WERE NOT PROVIDED. IN ADDITION, THE DATE AS TO WHEN THE DA VINCI SURGICAL PROCEDURE WAS PERFORMED IS UNKNOWN. ACCORDING TO THE SURGEON, THE INJURIES ALLEGEDLY OCCURRED DURING THE INSERTION OF A DYNAMIC ATRIAL RETRACTOR INSTRUMENT. THE SURGEON EXPLAINED THAT THERE IS ROUTINELY MORE RESISTANCE TO PASS INSTRUMENTS ON THE XI THAN ON THE SI SURGICAL SYSTEMS. THE SURGEON WAS REFERRING TO THE DIFFERENCE IN RESISTANCE WHEN INSERTING AN INSTRUMENT THROUGH A CANNULA SEAL ON THE DA VINCI XI SURGICAL SYSTEM COMPARED TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON FURTHER STATED THAT THERE HAS BEEN NO RECURRENCE OF THE ISSUE AT THE SITE AND THE SURGICAL TEAM LEARNED FROM THE EXPERIENCE WITH A BETTER UNDERSTANDING OF THE RESISTANCE DIFFERENCES BETWEEN THE CANNULA SEALS OF THE TWO DA VINCI SURGICAL SYSTEMS. THE PATIENT REPORTEDLY REQUIRED SURGERY TO REPAIR THE LIVER INJURY THE DAY AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED.

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 INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED TRANSORAL ROBOTIC (TORS) PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A CAROTID BLEED AND BLED TO DEATH. ON JULY 26, 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ISI WAS INFORMED OF THE PATIENT DEATH BY THE SURGEON. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2016 AND WAS UNRECORDED ON VIDEO. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE ALSO NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2016, THE CAROTID BLEED WAS IDENTIFIED AND THE PATIENT PASSED AWAY THE SAME DAY. PRIOR TO PASSING AWAY, IT IS UNKNOWN IF THE PATIENT RECEIVED ANY MEDICAL INTERVENTION DUE TO THE CAROTID BLEED. IT IS UNCLEAR AT THIS TIME IF AN AUTOPSY HAS BEEN OR WILL BE PERFORMED. NO FURTHER CLINICAL 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 HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON JULY 22, 26, AND 29, 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIME, AN ANTIBIOTIC, INTRAVENOUSLY. THE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON DECEMBER 12, 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5073827, WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6), MY MOTHER (B)(6), (DOB (B)(6)) WAS OPERATED ON VIA DA VINCI ROBOTIC PROCEDURE BY TWO PHYSICIAN AT ROPER HOSPITAL IN (B)(6) FOR RIGHT UPPER LOBECTOMY. SHE IMMEDIATELY COMPLAINED OF ABDOMINAL PAIN (NEAR 8TH INTERCOSTAL SPACE WHERE CAMERA FROM ROBOT WAS INSERTED). THAT AFTERNOON FOLLOWING PROCEDURE, AND EVERY DAY THEREAFTER (DOCUMENT IN NURSE'S NOTES) UNTIL IT WAS DISCOVERED A FEW WEEK [SIC] LATER, HER RIGHT COLON HAD BEEN PERFORATED FOR SOME TIME AND EMERGENCY SURGERY WAS PERFORMED, AND THEN ALMOST BLED OUT FROM ANASTOMOSIS. THE DELAYED DIAGNOSIS OF PERFORATED COLON RESULTED IN A HEALTH DECLINE THAT RESULTED IN HER DEATH ON (B)(6) 2016. SHE TESTED POSITIVE FOR C. FREUNDII, CITROBACTER FREUNDII IS A SPECIES FACULTATIVE ANEROBIC GRAM-NEGATIVE BACTERIA OF THE (ENTERFOBACTERIACEAE FAMILY) IN HER RIGHT LUNG, AND WHITE BLOOD CELL COUNT WAS 59,000 FROM BACTERIA'S AND STOOL LEAKING OUT INTO ABDOMINAL CAVITY. SHE ALSO TESTED POSITIVE FOR SEVERAL OTHER BACTERIA'S INCLUDING CANDIDA TROPICALIS (FUNGUS). THANK YOU FOR LOOKING INTO THIS MATTER TO HELP WITH

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 HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIME, AN ANTIBIOTIC, INTRAVENOUSLY. THE E. COLI FROM T

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2016, MY MOTHER (B)(6), (DOB (B)(6)) WAS OPERATED ON VIA DA VINCI ROBOTIC PROCEDURE BY TWO PHYSICIANS AT ROPER HOSPITAL IN (B)(6) FOR RIGHT UPPER LOBECTOMY. SHE IMMEDIATELY COMPLAINED OF ABDOMINAL PAIN (NEAR 8TH INTERCOSTAL SPACE WHERE CAMERA FROM ROBOT WAS INSERTED). THAT AFTERNOON FOLLOWING PROCEDURE, AND EVERY DAY THEREAFTER (DOCUMENTED IN NURSE'S NOTES) UNTIL IT WAS DISCOVERED A FEW WEEK LATER, HER RIGHT COLON HAD BEEN PERFORATED FOR SOME TIME AND EMERGENCY SURGERY WAS PERFORMED, AND THEN ALMOST BLED OUT FROM ANASTOMOSIS. THE DELAYED DIAGNOSIS OF PERFORATED COLON RESULTED IN A HEALTH DECLINE THAT RESULTED IN HER DEATH ON (B)(6) 2016. SHE TESTED POSITIVE FOR C. FREUNDII, CITROBACTER FREUNDII IS A SPECIES OF FACULTATIVE ANEROBIC GRAM-NEGATIVE BACTERIA OF THE (ENTEROBACTERIACEAE FAMILY) IN HER RIGHT LUNG, AND WHITE BLOOD CELL COUNT WAS 59,000 FROM BACTERIA'S AND STOOL LEAKING OUT INTO ABDOMINAL CAVITY. SHE ALSO TESTED POSITIVE FOR SEVERAL OTHER BACTERIA'S INCLUDING CANDIDA TROPICALIS (FUNGUS). THANK YOU FOR LOOKING INTO THIS MATTER TO HELP WITH COMPLIANCE AND MAY BE PREVENTING THIS FROM HAPPENING TO OTHER PTS AND FAMILIES.

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-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM A BRANCH OF THE SUPERIOR PANCREATICODUODENAL ARTERY. THE SURGEON REPORTEDLY USED A FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND COMPRESSION TO STOP THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, IT TOOK THE SURGICAL STAFF APPROXIMATELY 6 HOURS TO CONTROL THE BLEEDING. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. APPROXIMATELY 23 MINUTES AFTER THE DA VINCI-ASSISTED GASTRECTOMY PROCEDURE WAS COMPLETED AND THE PATIENT'S ABDOMEN WAS CLOSED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A BLOODY DRAIN WAS ALSO IDENTIFIED. A TRANSFUSION WAS ADMINISTERED AND THE PATIENT'S BLOOD PRESSURE RECOVERED TO 70 MM HGS. THE PATIENT WAS REPORTEDLY DIAGNOSED WITH HEMOPERITONEUM AND INTRAPERITONEAL OBSERVATION WAS PERFORMED WITH A LAPAROSCOPE. FRESH BLOOD AND BLOOD CLOTS WERE FOUND. AFTER SUCTIONING WAS PERFORMED, THE SOURCE OF THE BLEEDING WAS FOUND TO BE THE PANCREATIC HEAD. THE SURGEON MADE THE DECISION TO PERFORM OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE SURGEON APPLIED SUTURES TO 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 HAS BEEN REPORTED THAT AFTER COMPLETION OF THREE SEPARATE DA VINCI-ASSISTED SURGICAL PROCEDURES, EACH PATIENT DEVELOPED A SERIOUS POST-OPERATIVE INFECTION/ABSCESS. AS A RESULT OF THE POST-OPERATIVE COMPLICATIONS, TWO OF THE PATIENTS UNDERWENT A FOLLOW-UP, UNSPECIFIED SURGICAL PROCEDURE AND WERE THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE TWO PATIENTS WERE REPORTEDLY RECEIVING ARTIFICIAL RESPIRATION. THE THIRD PATIENT WAS SCHEDULED TO UNDERGO AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2016, BUT IT IS UNKNOWN WHETHER THIS OCCURRED. ALL THREE PATIENTS HAD BLOOD RESULTS THAT WERE POSITIVE FOR DIFFERENT STRAINS OF ESCHERICHIA COLI (E.COLI) BACTERIA. ON JULY 22, 26, AND 29, 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED POST-OPERATIVE INFECTIONS: REPORTEDLY, TWO OF THE AFFECTED PATIENTS UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURES ON (B)(6) 2016. BOTH SURGICAL PROCEDURES WERE PERFORMED BY THE SAME SURGEON. THE THIRD PATIENT REPORTEDLY HAD A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2016, BY A DIFFERENT SURGEON. ALL THREE PATIENTS RECEIVED CEFUROXIM, AN ANTIBIOTIC, INTRAVENOUSLY. THE E

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) 2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG TITLED, (B)(6) STORY. ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT SHE EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2014. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(6). BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, THE PATIENT WENT HOME THE SAME DAY. POST-OPERATIVELY, THE PATIENT EXPERIENCED HORRIFIC PAIN ON POST-OP DAY 5 AND FELT AS THOUGH SHE WAS SEVERELY CONSTIPATED. SHE REPORTEDLY HAD A SMALL FEVER AND VISITED HER PHYSICIAN. THE PATIENT INDICATED THAT THE PHYSICIAN THOUGHT SHE HAD A URINARY TRACT INFECTION (UTI) AND WAS PRESCRIBED AN UNSPECIFIED ANTIBIOTIC. THE FOLLOWING DAY, THE PATIENT REPORTEDLY COULDN'T MOVE AND WAS RUSHED TO AN ER WHERE A CAT-SCAN WAS PERFORMED. THE PATIENT WAS FOUND TO HAVE A VAGINAL CUFF HEMATOMA, INTERNAL BLEEDING, AND SEPSIS. THE PATIENT CLAIMED THAT HER BLOOD PRESSURE WAS 40/45 AND SHE WAS TEN MINUTES FROM DEATH. THE PATIENT ALLEGED

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 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG COMMENT STATING: OMG OMG OMG, ONE OF THE LADIES THAT WE GO TO CHURCH WITH JUST CALLED ASKING FOR PRAYERS FOR HER NIECE, (B)(6) JUST HAD SURGERY, A HYSTERECTOMY WITH THE ROBOT AND THEY KNICKED [SIC] HER SMALL INTESTINE [SIC] DURING THE PROCEDURE AND IT WAS THE SAME DOCTOR THAT DID IT TO ME!!!!!!! SHE IS IN INTENSIVE CARE......PLEASE PRAY. THE INTERNET BLOG COMMENT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S OPERATIVE COMPLICATION. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: HTTP://UNPLUGTHEROBOT.BLOGSPOT.COM.

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 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE (B)(4) INTERNET BLOG TITLED, (B)(4). ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT SHE EXPERIENCED MULTIPLE POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2014. THE INTERNET BLOG DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(4) BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT INDICATED THAT THE SURGEON INFORMED HER THAT SHE HAD NICKED THE OUTER LAYER OF THE BOWEL. HOWEVER, THE SURGEON REPORTEDLY DENIED THAT SHE HAD PUNCTURED THE PATIENT'S BOWEL. THE PATIENT CLAIMED THAT SHE WAS INFORMED THAT THE SURGICAL PROCEDURE WOULD LAST 2-3 HOURS. HOWEVER, ACCORDING TO THE PATIENT, THE DA VINCI-ASSISTED SURGICAL PROCEDURE TOOK ALMOST 6 HOURS. DURING THE MIDDLE OF THE NIGHT, THE PATIENT INDICATED THAT HER BLOOD PRESSURE DROPPED DANGEROUSLY AND SHE WAS GIVEN LOTS OF MEDICATION TO RAISE HER BLOOD PRESSURE. DUE TO HER BLOO

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 06/01/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE UNPLUG THE ROBOT INTERNET BLOG TITLED, TINA'S STORY. ACCORDING TO THE INTERNET BLOG, THE PATIENT INDICATED THAT SHE UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND CLAIMED THAT THE SURGEON DAMAGED NERVES IN HER BLADDER AND POSSIBLY INTESTINES. AS A RESULT, THE PATIENT ALSO CLAIMED THAT SHE HAS EXPERIENCED NUMEROUS POST-OPERATIVE COMPLICATIONS. THE INTERNET BLOG DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(4). BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER CONSULTING WITH HER SURGEON, THE PATIENT MADE THE DECISION TO UNDERGO A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE IN (B)(6) 2014. ACCORDING TO THE PATIENT, SHE EXPERIENCED A LOT OF PAIN WHILE IN THE RECOVERY ROOM AND WAS TREATED WITH AN UNSPECIFIED PAIN PILL. THE PATIENT ALSO MENTIONED THAT SHE STARTED BLEEDING AND HAVING MORE PAIN. THE PATIENT WAS REPORTEDLY GIVEN A PAD AND INFORMED THAT SHE WOULD BE FINE. THE PATIENT WAS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI - ASSISTED HYSTERECTOMY WITH PARA-AORTIC LYMPH NODE DISSECTION PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE INITIAL REPORTER, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE SURGEON INFORMED HER THAT THE DA VINCI - ASSISTED SURGICAL PROCEDURE WAS SMOOTH AND STRAIGHTFORWARD. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON POST-OPERATIVE DAY 1, THE PATIENT'S STOMACH WAS NOTED TO BE DISTENDED AND THE PATIENT DID NOT SEEM TO BE WELL. ON POST-OPERATIVE DAY 2, A CT-SCAN WAS PERFORMED ON THE PATIENT AND WAS FOUND TO BE NEGATIVE. ON POST-OPERATIVE DAY 3, ANOTHER CT-SCAN WAS PERFORMED AND A PERFORATION OF THE DUODENUM WAS IDENTIFIED. ON POST-OPERATIVE DAY 6, THE PATIENT UNDERWENT OPEN SURGERY TO REPAIR A 5 MM PERFORATION OF THE DUODENUM. THE CSR INDICATED THAT THE SURGEON INFORMED HER THAT THE BOWEL PERFORATION WAS SURROUNDED BY WHITISH TISSUE MEASURING 1 CM X 1 CM. ACCORDING TO THE CSR, THE SITE BELIEVES THE WHITISH TISSUE AND PERFORAT

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 THE DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE THE SURGICAL STAFF EXPERIENCED A LOSS OF 3D VISION. AS A RESULT, IT WAS ALLEGED THAT THE SURGICAL PROCEDURE WAS PROLONGED AND THE PATIENT EXPERIENCED AN ABNORMAL BLOOD LOSS. NO DETAILS WERE PROVIDED REGARDING THE SEVERITY OR QUANTITY OF THE BLOOD LOSS. IT IS UNKNOWN HOW LONG THE PROCEDURE WAS PROLONGED. ALSO, IT IS UNKNOWN IF MEDICAL INTERVENTION OR ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO THE ABNORMAL BLOOD LOSS OR PROLONGED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. ON (B)(6) 2016, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS ABLE TO REPLICATE THE REPORTED VISION ISSUES WITH THE DA VINCI SYSTEM. THE FSE RESOLVED THE REPORTED VISION ISSUES BY REPLACING THE HRSV AND BLUE FIBER CABLE. THE FSE THEN TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(6) 2016, ISI CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ALLEGED VISION ISSUE OCCURRED JUST AT THE BEGINNING OF THE PROCEDURE. AT THE TIME THE EVENT OCCURRED, AN IS

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 04/26/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE (B)(6) ARTICLE TITLED, DO YOU NEED COMPLEX SURGERY? SOME DOCTORS MAY NOT HAVE MUCH PRACTICE (2016). ACCORDING TO THE ARTICLE, A (B)(6) MALE PATIENT CHOSE TO UNDERGO ELECTIVE ABDOMINAL SURGERY IN HIS HOME TOWN OF (B)(6), AFTER ROBOTIC PROSTATE SURGERY AT A LARGER HOSPITAL IN (B)(6) NEARLY KILLED HIM AND LEFT HIM WITH A COLOSTOMY. THE PATIENT REPORTEDLY WANTED TO BE BACK IN HIS TOWN AND HAD CONFIDENCE IN HIS SURGEON. THE PATIENT UNDERWENT A SEVEN-HOUR OPERATION THAT WENT WELL AT A SPECIFIED HOSPITAL. THE ARTICLE INDICATED THAT THE PATIENT RECENTLY SAID HE IS ALMOST BACK TO NORMAL.

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 THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE THE PATIENT EXPERIENCED AN INTRA-OPERATIVE COMPLICATION WHICH REQUIRED CONVERSION TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE DA VINCI-ASSISTED SURGICAL PROCEDURE STARTED AT 12:15 PM. THE PROCEDURE PROGRESSED UNEVENTFULLY UNTIL THE ESOPHAGEAL DISSECTION WAS NEARLY COMPLETED. AT THAT POINT, MAJOR BLEEDING WAS OBSERVED AT 1:46 PM BY THE CONSOLE SURGEON. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING QUICKLY BY APPLYING PRESSURE WITH AN UNSPECIFIED ROBOTIC INSTRUMENT. THE INITIAL REPORTER INDICATED THAT THE ESTIMATED BLOOD LOSS AT THAT STAGE OF THE SURGICAL PROCEDURE WAS 30 ML. THE SURGEON WAS UNABLE TO APPLY A CLIP OR SUTURES DUE TO POSITIONING; THEREFORE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY AT 2:20 PM WITH A VASCULAR CONSULTANT PRESENT AND IN CHARGE. THE INITIAL REPORTER INDICATED THAT THE SITE BELIEVES AN UNSPECIFIED THORACIC BRANCH OF THE AORTA HAD A HOLE. WHILE ATTEMPTING TO REPAIR THE HOLE VIA OPEN SURGERY, THE VESSEL DEFECT APPARENTLY WIDENED TO THE POINT WHERE THE AORTA BECAME INVOLVED. AFTER A THORACIC SURGEON WAS ABLE TO SUCCESSFULLY REPAIR THE VESSEL DEFECT WIT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN JANUARY 2, 2016 - MARCH 31, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2010 - (B)(6) 2015.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN 3 PREVIOUS DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. IN THIS PARTICULAR CASE, THE INITIAL REPORTER INDICATED THAT A LAPAROSCOPIC (NON-ROBOTIC) ASSIST PORT SITE HAD ALSO BECOME INFECTED POST-OPERATIVELY. THE INITIAL REPORTER INDICATED THAT 33 OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH E

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN (B)(6) ADDITIONAL DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. THE INITIAL REPORTER INDICATED THAT (B)(6) OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH EVIDENCE OF POSSIBLE POST-OPERATIVE INFECTIONS AND AT VARIOUS STAGES OF HEALING. THE SITE INITIALLY DETERMINED THAT THE POST-OPERATIVE PORT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN 3 ADDITIONAL DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. THE INITIAL REPORTER INDICATED THAT 33 OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH EVIDENCE OF POSSIBLE POST-OPERATIVE INFECTIONS AND AT VARIOUS STAGES OF HEALING. THE SITE INITIALLY DETERMINED THAT THE POST-OPERATIVE PORT SITE INFE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN 3 ADDITIONAL DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. THE INITIAL REPORTER INDICATED THAT 33 OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH EVIDENCE OF POSSIBLE POST-OPERATIVE INFECTIONS AND AT VARIOUS STAGES OF HEALING. THE SITE INITIALLY DETERMINED THAT THE POST-OPERATIVE PORT SITE INFE

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 REPORTEDLY UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON (B)(6) 2016. THE PLAINTIFFS¿ ATTORNEY ALLEGES THAT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT¿S LEFT URETER WAS SEVERED. AS A RESULT, THE PLAINTIFF¿S ATTORNEY CLAIMS THAT THE PATIENT HAS SUFFERED CHRONIC URINARY TRACT INFECTIONS, BLADDER LEAKAGE, PAIN, AND OTHER UNSPECIFIED PROBLEMS. IN ADDITION, THE PATIENT HAS REPORTEDLY BEEN A FREQUENT PATIENT AT HOSPITALS SINCE THE SURGERY TO ATTEMPT TO CORRECT HER PROBLEMS. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT¿S MEDICAL RECORDS.

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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INITIAL REPORTER ALLEGED THAT A WOMAN SUSTAINED A PUNCTURED IMPLANT DURING ROBOTIC SURGERY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5060196 WITH THE FOLLOWING EVENT DESCRIPTION: MY DAD WAS (B)(6), HE HAD TWO AREAS OF CANCER (COLON AND NEAR RECTUM) THAT HAD TO BE REMOVED BUT THEY WERE EARLY STAGES AND DID NOT REQUIRE CHEMO OR RADIATION. HE WAS HEALTHY AND STILL WORKED AS A SUPERVISOR FOR THE FEDERAL GOVERNMENT. HE WASN'T SICK AND HAD NO SYMPTOMS GOING INTO SURGERY. HE WASN'T TAKING ANY MEDS PRIOR TO SURGERY. ON (B)(6) 2016, HE HAD ROBOTIC SURGERY AT (B)(6) HOSPITAL IN (B)(6). SURGERY WAS SCHEDULED FOR 7 HRS, BUT TOOK 9 HRS. ON (B)(6) 2016, EMERGENCY SURGERY WAS PERFORMED TO REPAIR LEAKING ILEUM DUE TO NIPPED EQUIPMENT. BY THIS TIME, HIS ORGAN WERE HAVING PROBLEMS. ON (B)(6) 2016, ANOTHER EMERGENCY SURGERY. ON (B)(6) 2016, MY FATHER DIED. WHAT IS INTERESTING, I SENT A MASS EMAIL TO MY JOB REACHING OVER 100 PEOPLE TO EXPLAIN WHAT HAPPENED TO MY FATHER TO AVOID QUESTIONS. THERE WAS A CO-WORKER THAT LOST HER FATHER FROM ROBOTIC COLON SURGERY IN (B)(6) 2 YRS PRIOR. SHE EXPLAINED THE DOCTOR NIPPED AN AREA AND THEY HAD TO GO BACK INTO SURGERY TO FIX IT. HE LATER DIED; 7 DAYS LATER. PLEASE HELP US. THIS IS WRONG AND SO VERY SAD. MY FATHER'S L

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) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5061216 WITH THE FOLLOWING EVENT DESCRIPTION: UNDERWENT HYSTERECTOMY WITH DAVINCI ROBOT AND EXPERIENCED A 2 INCH LACERATION AT (B)(6) HOSPITAL IN (B)(6) PERFORMED BY DR. (B)(6). HIGH RISK FOR THIS PROCEDURE BECAUSE HAD A C-SECTION SEVERAL YEARS AGO. KEPT OVERNIGHT. QUESTION AS TO WHY DAVINCI ROBOT WAS USED WHEN POSSIBLY MORE DELICATE TECHNIQUE SHOULD HAVE BEEN USED RATHER THAN THE DAVINCI ROBOT.

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 TOWARDS THE END OF A DA VINCI-ASSISTED TRANSORAL ROBOTIC (TORS) PROCEDURE, THE ARMS OF THE PATIENT SIDE CART (PSC) ALLEGEDLY MOVED ON THEIR OWN AS THE SURGEON GOT UP FROM THE SURGEON SIDE CONSOLE (SSC). ACCORDING TO THE INITIAL REPORTER, AS THE SURGEON REMOVED HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV), ARM 1 AND ARM 2 MOVED FROM A VERTICAL TO HORIZONTAL POSITION WITH INSTRUMENTS STILL INSTALLED ON BOTH ARMS. AS A RESULT, ONE OF THE INSTRUMENTS ALLEGEDLY INJURED THE PATIENT'S TONGUE. THERE WERE NO REPORTS OF ANY SYSTEM ERROR MESSAGES. AFTER THE EVENT OCCURRED, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR ASSISTANCE. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND VERIFIED THAT THERE WERE NO RELATED SYSTEM ERROR MESSAGES. THE TSE HAD THE INITIAL REPORTER MOVE THE ARMS WITHOUT PRESSING ANY OF THE CLUTCH BUTTONS. THE INITIAL REPORTER WAS ABLE TO MOVE THE ARMS WHICH RETURNED TO THE SOFT-LOCK POSITION AS EXPECTED. ON (B)(6) 2016, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUES WITH THE ARMS OF THE PSC. THE FSE TESTED THE DA VINCI

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 CLINICAL LITERATURE REVIEW AN ARTICLE REFERENCED THAT POST A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN 2005, THE PATIENT PRESENTED TO A NEUROLOGIST IN 2009 WITH A HEADACHE. THE PATIENT HAD REPORTEDLY UNDERGOING CARDIAC CATHETERIZATION ON AN UNSPECIFIED DATE IN 2004. AN MRI OF THE PATIENT'S BRAIN SHOWED MULTIPLE MICRO-HEMORRHAGES. A CT-SCAN OF THE PATIENT'S HEAD WAS NEGATIVE. AN MRI PERFORMED IN 2003 DID NOT DEMONSTRATE ANY OF THE LESIONS. THE NEUROLOGIST PRESUMED THAT THE MRI FINDINGS WERE RELATED TO METALLIC MICRO-EMBOLI INSTEAD OF MICRO-HEMORRHAGES. NO FURTHER CLINICAL 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 BY THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL THAT A PATIENT, WHO IS ALSO A NEURO-RADIOLOGIST, UNDERWENT A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON AN UNSPECIFIED DATE IN 2008. THE PATIENT IS LOOKING INTO THE POSSIBILITY THAT HE DEVELOPED POST-OPERATIVE BRAIN HEMORRHAGES RELATED TO METALLIC EMBOLI. THE PATIENT'S MEDICAL HISTORY IS REPORTEDLY COMPLICATED AND POST-OPERATIVE MRI FINDINGS HAVE NOT BEEN CONFIRMED. NO FURTHER CLINICAL 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: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN OCTOBER 1, 2015 - JANUARY 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM APRIL 2008 - MAY 2015.

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 11/03/2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5072789 WITH THE FOLLOWING EVENT DESCRIPTION: I HAD A TOTAL HYSTERECTOMY ON (B)(6) FOR ENDOMETRIAL CANCER. MY SURGEON USED THE DAVINCI ROBOTIC DEVICE TO PERFORM THE SURGERY. IN (B)(6), I WAS DIAGNOSED WITH RECURRENT CANCER AND A PEA-SIZED NODULE AT ONE OF THE DAVINCI PORT SITES WAS CONFIRMED POSITIVE FOR ENDOMETRIAL CANCER METASTASIS. ON 11/08/2017, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT DIRECTLY FROM THE PATIENT: THE PATIENT UNDERWENT A DA VINCI LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, WASHINGS, BILATERAL PELVIC AND PERIAORTIC LYMPH NODE DISSECTION SURGERY ON (B)(6) 2016. SHE WAS DIAGNOSED WITH ENDOMETRIAL ENDOMETRIOID STAGE 1A, GRADE 2, WITH 18 NEGATIVE LYMPH NODES. ON (B)(6) 2016, THE PATIENT HAD A VAGINAL VAULT LESION BIOPSY THAT WAS CONFIRMED POSITIVE FOR METASTATIC ENDOMETRIOID ADENOCARCINOMA. ON (B)(6) 2016, THE PATIENT HAD A BIOPSY OF A PEA-SIZED NODULE, LOCATED AT THE RIGHT LOWER QUADRANT ROBOTIC PORT SITE. THE PATIENT INDICATED THAT THE BIOPSY OF THE PEA-SIZED NODULE ALSO SHOWED INVOLVED BY METASTATIC ENDOMETRIOID ADENOCARCINOMA. ON 11/2

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2016, IT WAS INITIALLY REPORTED BY THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE PERFORMED ON (B)(6) 2016, THE PATIENT WAS IN A BAD GENERAL STATE AND WAS TRANSFERRED TO EMERGENCY SERVICE. A SURGEON REPORTEDLY FOUND A LITTLE WOUND ON THE SMALL INTESTINE AT UNSPECIFIED TIME AFTER THE DA VINCI PROCEDURE WAS COMPLETED. THE PATIENT WAS NOTED TO BE IN THE ICU. ON 02/29/2016 AND 03/03/2016, ISI RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CSR AND THE ISI AREA SALES MANAGER (ASM). THE CSR WAS PRESENT DURING THE CASE AND THE INFORMATION SOURCE IS BASED ON THE CSR'S OBSERVATION AND DISCUSSIONS WITH THE PROCTOR: PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT HAD MULTIPLE, PREVIOUS ABDOMINAL SURGERIES AND COMPLICATIONS IN THE PAST INCLUDING A PARTIAL NEPHRECTOMY, CHOLECYSTECTOMY, BILE DUCT INFLAMMATION (CHOLEDOCH), AND A PERFORATION OF ANOTHER UNSPECIFIED STRUCTURE. THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF HAD DIFFICULTIES WITH PLACING THE TROCA

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 6 HOURS AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED INTRA-OPERATIVE BLEEDING. THE PATIENT'S BLOOD PRESSURE DROPPED TO APPROXIMATELY 50 MMHG POST-OPERATIVELY. THE PATIENT'S HEMOGLOBIN LEVEL ALSO REPORTEDLY DROPPED TO 9.7 G/DL. BEFORE THE PROCEDURE BEGAN, THE PATIENT'S HEMOGLOBIN WAS 12.9 G/DL. DURING THE PROCEDURE, HIS HEMOGLOBIN LEVEL WAS 9.8 G/DL. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO THE INITIAL REPORTER, THE PROGRESSION OF ANEMIA WAS NOT APPARENT AND THE PATIENT HAD LIGHTLY BLOODY DRAINAGE FROM AN UNSPECIFIED SOURCE. NO APPARENT ASCITES WAS FOUND VIA ULTRASOUND IN THE ABDOMINAL AREA. AFTER TRANSFUSIONS WERE ADMINISTERED, THE PATIENT'S BLOOD PRESSURE RECOVERED TO 80 MMHG. THE PATIENT'S RESPONSE WAS REPORTEDLY STILL POOR AND ABDOMINAL DISTENSION WAS NOTED. IN ADDITION, HIS DRAINAGE WAS NOTED TO BE BLOODY. THE PATIENT WAS THEN TAKEN BACK TO THE OR SINCE ABDOMINAL BLEEDING WAS IDENTIFIED. PRIOR TO THE START OF AN EMERGENCY OPERATION, THE PATIENT'S HEMOGLOBIN LEVEL WAS AT 6.7 G/DL. FRESH BLOOD AND BLOOD CLOTS IN THE INTRAPERITONEAL A

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-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNSPECIFIED INTRA-OPERATIVE COMPLICATIONS AND THE CASE WAS CONVERTED TO OPEN SURGERY. POST-OPERATIVELY, THE PATIENT EXPERIENCED COMPLICATIONS AND THE PATIENT SUBSEQUENTLY PASSED AWAY ON AN UNKNOWN DATE. ON 03/18/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS NOT PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO REPORTS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. TO HER KNOWLEDGE, THE PATIENT SUSTAINED AN UNSPECIFIED TYPE OF BOWEL INJURY. SHE DID NOT KNOW THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS OR DEATH.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5060196 WITH THE FOLLOWING EVENT DESCRIPTION: MY DAD WAS (B)(6), HE HAD TWO AREAS OF CANCER (COLON AND NEAR RECTUM) THAT HAD TO BE REMOVED BUT THEY WERE EARLY STAGES AND DID NOT REQUIRE CHEMO OR RADIATION. HE WAS HEALTHY AND STILL WORKED AS A SUPERVISOR FOR THE FEDERAL GOVERNMENT. HE WASN'T SICK AND HAD NO SYMPTOMS GOING INTO SURGERY. HE WASN'T TAKING ANY MEDS PRIOR TO SURGERY. ON (B)(6) 2016, HE HAD ROBOTIC SURGERY AT (B)(6) HOSPITAL IN (B)(6). SURGERY WAS SCHEDULED FOR 7 HRS, BUT TOOK 9 HRS. ON (B)(6) 2016, EMERGENCY SURGERY WAS PERFORMED TO REPAIR LEAKING ILEUM DUE TO NIPPED EQUIPMENT. BY THIS TIME, HIS ORGAN WERE HAVING PROBLEMS. ON (B)(6) 2016, ANOTHER EMERGENCY SURGERY. ON (B)(6) 2016, MY FATHER DIED. WHAT IS INTERESTING, I SENT A MASS EMAIL TO MY JOB REACHING OVER 100 PEOPLE TO EXPLAIN WHAT HAPPENED TO MY FATHER TO AVOID QUESTIONS. THERE WAS A CO-WORKER THAT LOST HER FATHER FROM ROBOTIC COLON SURGERY IN (B)(6) 2 YRS PRIOR. SHE EXPLAINED THE DOCTOR NIPPED AN AREA AND THEY HAD TO GO BACK INTO SURGERY TO FIX IT. HE LATER DIED; 7 DAYS LATER. PLEASE HELP US. THIS IS WRONG AND SO VERY SAD. MY FATHER'S L

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MY DAD WAS (B)(6), HE HAD TWO AREAS OF CANCER (COLON AND NEAR RECTUM) THAT HAD TO BE REMOVED BUT THEY WERE EARLY STAGES AND DID NOT REQUIRE CHEMO OR RADIATION. HE WAS HEALTHY AND STILL WORKED AS A SUPERVISOR FOR THE FEDERAL GOVERNMENT. HE WASN'T SICK AND HAD NO SYMPTOMS GOING INTO SURGERY. HE WASN'T TAKING ANY MEDS PRIOR TO SURGERY. ON (B)(6) 2016, HE HAD ROBOTIC SURGERY AT (B)(6) HOSPITAL IN (B)(6). SURGERY WAS SCHEDULED FOR 7 HRS, BUT TOOK 9 HRS. ON (B)(6) 2016, EMERGENCY SURGERY WAS PERFORMED TO REPAIR LEAKING ILEUM DUE TO NIPPED EQUIPMENT. BY THIS TIME, HIS ORGAN WERE HAVING PROBLEMS. ON (B)(6) 2016, ANOTHER EMERGENCY SURGERY. ON (B)(6) 2016, MY FATHER DIED. WHAT IS INTERESTING, I SENT A MASS EMAIL TO MY JOB REACHING OVER 100 PEOPLE TO EXPLAIN WHAT HAPPENED TO MY FATHER TO AVOID QUESTIONS. THERE WAS A CO-WORKER THAT LOST HER FATHER FROM ROBOTIC COLON SURGERY IN (B)(6) 2 YRS PRIOR. SHE EXPLAINED THE DOCTOR NIPPED AN AREA AND THEY HAD TO GO BACK INTO SURGERY TO FIX IT. HE LATER DIED; 7 DAYS LATER. PLEASE HELP US. THIS IS WRONG AND SO VERY SAD. MY FATHER'S LAST WORDS, "THEY MESSED UP". IT'S HEARTBREAKING BECAUSE HE SUFFERED IN PAIN WHILE THE DOCTORS TRIED TO FIGURE IT OUT. OUR DOC

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6). RE: DA VINCI ROBOT IS A VERY DANGEROUS OPERATION DEVICE! DEAR SIR: I AM WRITING A LETTER TO YOU EXPLAINING JUST WHAT HAPPENED TO ME WHEN I WAS OPERATED ON VIA DA-VINCI ROBOT. FIRST OF ALL, MY UROLOGIST/SURGEON (MR. (B)(6)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED BECAUSE ON THE GLEASON SCALE READING OF 6. DR. (B)(6) SAID THAT HE RECOMMENDED USING THE DA-VINCI ROBOT BECAUSE IT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE EVERYTHING ON A BIG SCREEN SO THAT HE WOULD BE ABLE NOT TO CUT ANY NERVES OR BLOOD VESSELS THAT WOULD AFFECT ME FROM HAVING SEX AND THAT IT WOULD PREVENT ME FROM HAVING INCONTINENCE. DR. (B)(6) CONVINCED ME AND MY FAMILY THAT THE DA-VINCI ROBOT WAS THE WAY TO GO AND THAT MY FAMILY COULD PICK ME UP AT THE HOSPITAL THE NEXT MORNING. WHEN MY FAMILY CAME TO GET ME, I WAS IN A BAD WAY. I COULD NOT STAND, EAT, MOVE AND I WAS IN SO MUCH PAIN. THE NURSES HAD PUT ON ME A DRAINAGE BAG AND ABOUT EVERY TWO HOURS THE BAG WOULD FILL UP WITH BRIGHT RED BLOOD JUST LIKE IF I HAD JUST CUT MYSELF. DRAINAGE WOULD NOT BE THE SAME COLOR AS PURE BLOOD. DR (B)(6) TOLD MY FAMILY THAT I WOULD NOT BE GOING

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) 2016, IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY PROCEDURE, AN UNSPECIFIED BIPOLAR INSTRUMENT AUTO-FIRED AND THE PATIENT SUSTAINED A BURN INJURY TO THE COLON. DETAILS REGARDING THE BURN INJURY WERE NOT INITIALLY PROVIDED. THE INITIAL REPORTER INDICATED THAT THE CORD OF THE BIPOLAR INSTRUMENT WAS CORRECTLY PLUGGED INTO A BIPOLAR PORT ON THE ELECTROSURGICAL UNIT (ESU). ON 01/12/2016, AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE. THE TFS DETERMINED THAT THE SURGICAL STAFF HAD ACCIDENTALLY PLUGGED THE BIPOLAR CONNECTORS INTO THE MONOPOLAR COAG PORT ON THEIR NON-ISI ESU. DURING THE FIELD EVALUATION, THE TFS OBSERVED A DA VINCI SURGICAL PROCEDURE AFTER VERIFYING THAT THE BIPOLAR CONNECTORS WERE PLUGGED INTO THE CORRECT PORT ON THE ESU. DURING THE SURGICAL PROCEDURE, THE DA VINCI SURGICAL SYSTEM WORKED APPROPRIATELY. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE SURGICAL STAFF SWITCHED THE BIPOLAR CONNECTORS ON THE ESU TO THE MONOPOLAR PORT. THE SURGICAL STAFF WAS THEN ABLE TO REPLICATE THE AUTO-FIRING ISSUE WITH A BIPOLAR INSTRUMENT. THE SURGICAL STAFF MADE NOTE OF THE ISSUE AND MA

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-ASSISTED SURGICAL PROCEDURE, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS (MCS) AND A VESSEL IN CLOSE PROXIMITY TO THE INSTRUMENT QUICKLY BLANCHED AND THEN BURST. THE SURGEON PROVIDED INTUITIVE SURGICAL, INC. (ISI) WITH A VIDEO CLIP OF THE REPORTED EVENT. DURING THE VIDEO, A VESSEL TOWARDS THE BACK END OF AN MCS INSTRUMENT BLANCHED QUICKLY FROM PALE WHITE TO BRIGHT WHITE IN COLOR AND THEN BURST. THE VIDEO REVEALS THAT WHILE ENERGY WAS BEING APPLIED, THE BLADES OF THE MCS INSTRUMENT WERE RESTING AGAINST THE VESSEL THAT WAS EVENTUALLY DAMAGED. THE VIDEO CLIP ALSO REVEALED THAT THE MCS TIP COVER ACCESSORY INSTALLED ON THE MCS INSTRUMENT WAS TORN AT THE MOUTH OF THE ACCESSORY. HOWEVER, THERE IS NO INDICATION THAT THE ACCESSORY DAMAGE CAUSED OR CONTRIBUTED TO THE VESSEL INJURY. THE SURGEON CLAIMED THAT THIS EVENT MIGHT NOT HAVE OCCURRED IF HE HAD BEEN USING DIFFERENT ENERGY MODALITIES AND SETTINGS. ON (B)(6) 2015, ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING REGARDING THE REPORTED EVENT: THE EVENT OCCURRED DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE THAT HE PERFORMED ON AN UNSPECIFIED DATE. THE VESSEL THAT BURST WAS THE RI

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 ASSISTED GASTRIC BYPASS PROCEDURE PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED BLEEDING FROM AN ENTEROTOMY CLOSURE THE FOLLOWING DAY, REQUIRING THE PATIENT TO UNDERGO A 2ND SURGICAL PROCEDURE TO REPAIR THE CLOSURE. 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: PROGRASP FORCEPS, WERE BEING USED AND SURGEON STATED THEY WEREN'T WORKING CORRECTLY. INSTRUMENT REMOVED FROM PT. UPON INSPECTION A WIRE WAS FRAYED ON DEVICE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT'S SMALL BOWEL HERNIATED THROUGH ONE OF THE 8MM ROBOTIC PORT SITES ON POST-OPERATIVE DAY 7. ON (B)(6) 2015 AND (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. AFTER THE ROBOTIC PORTION OF THE CASE WAS COMPLETED, THE SURGEON CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY TO FINISH AN ANASTOMOSIS. THERE WAS NO ALLEGATION FROM THE SURGEON OR SURGICAL STAFF THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2015, THE PATIENT'S SMALL BOWEL WAS FOUND TO HAVE HERNIATED THROUGH ONE OF THE 8MM ROBOTIC PORT SITES. THE PATIENT UNDERWENT ANOTHER PROCEDURE TO REPAIR THE HERNIATION. THAT SAME DAY ON (B)(6) 2015, THE PATIENT REPORTEDLY CODED. THE INITIAL REPORTER DID NOT KNOW THE REASON AS TO WHY THE PATIENT CODED. THE INITIAL REPORTER STATED THAT THE SURGEON DOES NOT CLOSE ANY ROBOTIC PORT SITES THAT ARE LESS THAN 10MM. ON (B)(6) 2015, THE INITIAL REPOR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE PERFORMED ON (B)(6) 2015, THE PATIENT WAS READMITTED TO A HOSPITAL ON (B)(6) 2015 WHERE HE RECEIVED UNSPECIFIED TREATMENT FOR AN UNSPECIFIED LEAK. THE PATIENT REPORTEDLY PASSED AWAY IN (B)(6) 2016 FROM AN UNKNOWN CAUSE. HOWEVER, ACCORDING TO THE INITIAL REPORTER, THE SURGEONS WERE NOT ATTRIBUTING THE PATIENT'S DEATH TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ON 05/06/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. THE DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE WAS COMPLETED AND THE PATIENT INITIALLY DID VERY WELL. ON 05/10/2016 AND 05/11/2016, THE INITIAL REPORTER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AFTER SPEAKING TO THE SURGEON: THE SURGEON WAS UNABLE TO PROVIDE DETAILS AS TO WHAT TYPE OF LEAK WAS IDENTIFIED. HE DID NOT KNOW IF THE LEAK WAS FROM AN ANASTOMOSIS OR A STAPLE LI

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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGEAL DIVERTICULUM REPAIR AND MYOTOMY PROCEDURE, THE SURGEON ALLEGEDLY HIT THE PATIENT'S AORTA AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT REPORTEDLY PASSED AWAY SHORTLY AFTER IN THE ICU. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE REPORTED EVENT OCCURRED ABOUT AN HOUR AFTER THE SURGEON HAD BEEN SITTING AT THE SURGEON SIDE CONSOLE (SSC). AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION AND WAS USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO ALLEGATION FROM THE SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A DAY AFTER THE EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON. THE SURGEON DID NOT PROVIDE A POSSIBLE CAUSE TO THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. HOWEVER, THE CSR INDICATED THAT SHE SPOKE TO A SURGICAL ASSISTANT WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGICAL ASSISTANT INFORMED HER THAT THE SURGEON NICK

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2015. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2012 - (B)(6) 2015.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10/01/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056296 WITH THE FOLLOWING EVENT DESCRIPTION: THIS IS A LATE REPORT AS WE WERE UNAWARE WE COULD HAVE REPORTED EARLIER TO FDA. MY MOTHER, (B)(6), AT TIME OF DEATH, WAS UNDERGOING A MITRAL VALUE [SIC] REPAIR WITH THE SURGEON, DR. (B)(6) , USING THE DAVINCI ROBOT. THIS OCCURRED AT (B)(6) ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, THE ROBOT NICKED HER HEART WHICH RESULTED IN BLEEDING OUT AND EMERGENCY OPEN HEART SURGERY. SHE NEVER RECOVERED AND DEVELOPED SEPSIS INFECTION 4 DAYS LATER. WE WERE INFORMED LATER THAT OUR MOM WAS THE ONLY THE 3RD PATIENT FOR HEART VALVE SURGERY ON THIS ROBOT. WE ALSO ARE AWARE THAT ANOTHER WOMAN DIED SUBSEQUENTLY BY THE SAME ROBOT AND PHYSICIAN. THE DOCTOR LEFT TOWN AFTER THIS. (WE NEVER FILED A LAWSUIT DUE TO (B)(6) LAWS ON DAMAGES.) I AM WRITING THIS TO INFORM THE FDA AND TO NOTIFY YOU OF AN ADVERSE EVENT FOR YOUR STATS OF THIS DAVINCI ROBOT. MY HOPE IS THAT NO ONE WILL HAVE TO DIE FROM THIS ROBOT IN THE FUTURE IN THE CARDIAC REALM OF USE FOR DAVINCI. THANK YOU. (B)(6). THIS MDR ADDRESSES THE SECOND PATIENT DEATH NOTED IN THE EVENT DESCRIPTION. REFER TO THE MDR REPORT WITH PATIE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 5. NO FURTHER CLINICAL INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LEFT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS ON POST-OPERATIVE DAY 1. THE PATIENT WAS FOUND TO HAVE A HEMATOMA ON HER SPLEEN AND REMAINED IN THE ICU FOR 2 DAYS. THE PATIENT'S HEMOGLOBIN REPORTEDLY DROPPED 5 GRAMS AND SHE WAS GIVEN 2 UNITS OF BLOOD. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS AND THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. THE CSR INDICATED THAT THE SURGEON BELIEVED THAT THE WRISTS OF THE DA VINCI INSTRUMENTS OR TRADITIONAL LAPAROSCOPIC INSTRUMENTS USED THROUGH THE ASSISTANT PORT MADE CONTACT WITH THE SPLEEN WHICH CAUSED THE HEMATOMA. ON (B)(6) 2015, ISI CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON INDICATED THAT SHE INSERTED THE ASSISTANT TROCAR INTO THE 9TH INTERSPACE WHICH IS A FEW MILLIMETERS ABOVE THE DIAPHRAGM. THE SURGEON BELIEVES THE ASSISTANT SURGEON MAY HAVE BLUNTLY HIT THE SPLEEN THROUGH TH