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 UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PANCREATIC FISTULA/LEAK. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A SURGEON AT A DIFFERENT HOSPITAL POSSIBLY RELATED TO THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD POSSIBLY EXPIRED AFTER SURGERY. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS.

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 08/27/2018, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPIC SURGEONS CLINICAL ARTICLE TITLED ¿ROBOTIC-ASSISTED TRANSTHORACIC ESOPHAGEAL DIVERTICULECTOMY¿ (BALCI ET AL., 2018). IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED ¿TRANSTHORACIC ESOPHAGEAL DIVERTICULECTOMY PROCEDURE, A PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AND SUBSEQUENTLY EXPIRED." ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT THE DA VINCI-ASSISTED SURGICAL PROCEDURE FOR A DIVERTICULUM. THE PATIENT ALSO UNDERWENT WEDGE BIOPSIES FROM THE RIGHT LUNG. THE OPERATIVE TIME WAS 165 MINUTES AND IT WAS NOTED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. ON POST-OPERATIVE DAY #2, LIQUIDS WERE STARTED AFTER NO LEAKS WERE FOUND. ON POST-OPERATIVE DAY #4, THE PATIENT HAD A FEVER OF 100.4 DEGREES FAHRENHEIT ALTHOUGH THERE WAS NO EVIDENCE OF LEAKAGE. ON POST-OPERATIVE DAY #5, THE PATIENT DEVELOPED RESPIRATORY DISTRESS IN ADDITION TO HAVING ONGOING FEVER. A CT-SCAN WAS PERFORMED FOR SUSPICION OF AN ANASTOMOTIC LEAKAGE. PLEURAL EFFUSION WAS OBSERVED IN THE RIGHT LUNG WITH FREE FLUID AND AIR IN THE OPERATIVE AREA. THE PATIENT WAS TRANSFERRED TO THE ICU AND ANTIBIOTI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN INNOVATIONS JOURNAL ARTICLE TITLED, "EARLY CLINICAL EXPERIENCES OF ROBOTIC ASSISTED AORTIC VALVE REPLACEMENT FOR AORTIC VALVE STENOSIS WITH SUTURELESS AORTIC VALVE¿ (NAGAOKA, E. ET. AL. 2020). IN THIS ARTICLE, STUDY DATA WAS RETROSPECTIVELY COLLECTED FROM 2 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED AORTIC VALVE REPLACEMENT (AVR) IN A SINGLE INSTITUTION BETWEEN MAY AND JUNE 2018. THERE WERE NO MAJOR COMPLICATIONS REPORTED AND NO CONVERSIONS TO STERNOTOMY. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: "ONE PATIENT HAD FLUID OVERLOAD POSTOPERATIVELY DUE TO VASODILATATION AND REQUIRED AGGRESSIVE DIURESIS. OTHERWISE, POSTOPERATIVE CONVALESCENCE WAS UNCOMPLICATED. THEY WERE DISCHARGED HOME AT DAYS 4 AND 10 AFTER OPERATION, DUE TO POSTOPERATIVE ATRIAL FIBRILLATION RESPECTIVELY (TABLE 3)." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE ARTICLE: "THE POST-OPERATIVE OUTCOME WAS UNRELATED TO THE FUNCTION OF THE DA VINCI SYSTEM." HE FURTHER INDICATED THAT "THERE ARE NO SUCH ALLEGATIONS" THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED BOWEL INJURY. DUE TO THE INTRA-OPERATIVE COMPLICATION, THE SURGICAL PROCEDURE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON AN UNSPECIFIED DATE, THE PATIENT REPORTEDLY EXPIRED. THE CAUSE OF THE DEATH WAS NOT PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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 ¿ADHESIOLYSIS AND REDUCTION OF A SLIPPED NISSEN WITH COMPLETION LAPAROTOMY, REPAIR OF HIATAL HERNIA AND REDO OF NISSEN FUNDOPLICATION¿ PROCEDURE ON (B)(6) 2017. THE PLAINTIFFS¿ ATTORNEY ALLEGES THAT THE PATIENT ¿EXPERIENCED COMPLICATIONS DURING THE SURGERY, NAMELY ISSUES WITH THE PATIENT¿S BLOOD PRESSURE AND OXYGENATION WHEN HE INCREASED THE PRESSURE OF THE GAS INSUFFLATING THE PATIENT¿S ABDOMINAL WALL.¿ THE PLAINTIFFS¿ ATTORNEY NOTED THAT WHEN THE PRESSURE WAS DECREASED, THE SURGEON¿S ¿VISIBILITY ALSO DECREASED, LEADING HIM TO UNDOCK THE ROBOT AND CONVERT THE OPERATION TO AN OPEN SURGERY.¿ AT AN UNSPECIFIED TIME DURING THE SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED AN ¿ESOPHAGEAL PERFORATION RESULTING IN THE LEAKAGE OF STOMACH CONTENTS INTO HER MEDIASTINUM.¿ AS A RESULT, THE PATIENT EXPERIENCED ¿IMMEDIATE RESPIRATORY COMPLICATIONS INCLUDING ATELECTASIS, PLEURAL FLUID AND PNEUMONIA, AND EVENTUALLY TO SEPSIS.¿ THE PATIENT ALLEGEDLY EXPERIENCED ¿PAIN AND SUFFERING¿ FROM (B)(6) 2017. DURING THIS TIME, THE PATIENT REPORTEDLY HAD ¿THE INABILITY 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: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE PATIENT EXPIRED ON AN UNSPECIFIED DATE. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL PROCEDURE WAS LONG AND THERE WERE UNSPECIFIED COMPLICATIONS. THERE WERE NO REPORTED SYSTEM FAILURE ISSUES. ON 07/24/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER, AN ISI CLINICAL SALES REPRESENTATIVE (CSR), AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. TO HER KNOWLEDGE, THE DA VINCI SURGICAL SYSTEM WAS IN THE OPERATING ROOM (OR) FOR APPROXIMATELY 13 HOURS. TO HER UNDERSTANDING, THE DA VINCI SURGICAL SYSTEM WAS USED FOR THE ENTIRE DURATION OF THE SURGICAL PROCEDURE AND THERE WERE NO REPORTS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE CSR STATED THAT THE PATIENT REPORTEDLY HAD A TON OF ADHESIONS WHICH TOOK A WHILE TO CLEAR IN ORDER FOR THE SURGEON TO GAIN ACCESS TO THE PROSTATE. THE SURGICAL PROCEDURE WAS COMPLETED. HOWEVER, POST-OPERATIVELY THE PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN AND UNDERWENT SOME TYPE OF UNSPECIFIED SCAN. THE CSR WAS UN

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 NISSEN FUNDOPLICATION PROCEDURE, THE INSUFFLATION WAS LOST AFTER THE SURGEON SWAPPED FROM ARM 1 TO ARM 3. AT THE TIME THE EVENT OCCURRED, A HARMONIC ACE CURVED SHEARS INSTRUMENT WAS INSTALLED ON ARM 1 AND A DOUBLE FENESTRATED GRASPER INSTRUMENT WAS INSTALLED ON ARM 3. AS A RESULT OF THE LOSS OF INSUFFLATION, THE PATIENT'S DIAPHRAGM SLID DOWN AND THE HARMONIC ACE CURVED SHEARS INSTRUMENT ALLEGEDLY PUNCTURED A HOLE IN THE PATIENT'S RIGHT VENTRICLE. ONCE THE SURGEON IDENTIFIED THE OPERATIVE COMPLICATION, A CARDIO SURGEON WAS CALLED FOR IMMEDIATE OPEN HEART SURGERY. ON 06/21/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SITE HAS NOT DETERMINED THE CAUSE OF THE LOSS OF INSUFFLATION DURING THE SURGICAL PROCEDURE. NO ISSUES WERE IDENTIFIED WITH THE INSUFFLATION TUBING, ASSIST PORT, CANNULAS, OR CANNULA SEALS. THE SURGEON BELIEVES THE PUNCTURE WOUND TO THE PATIENT'S RIGHT VENTRICLE OCCURRED AS A RESULT OF THE LOSS OF INSUFFLATION AND MOVEMENT OF DIAPHRAGM. NO INSTRUMENTS WERE MOVED AFTER INSUFFLATION WAS LOST. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS

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, DURING AN ANONYMOUS CONSUMER SURVEY, THAT THE PATIENT'S COLON WAS ALLEGEDLY NICKED BY AN UNSPECIFIED DEVICE WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE. AS A RESULT, THE INITIAL REPORTER (THE PATIENT'S FRIEND) CLAIMED THAT THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION AND WAS ADMITTED TO THE ICU FOR ABOUT 2 WEEKS BEFORE HE WAS RELEASED TO GO HOME. THE FOLLOWING NIGHT AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT WAS READMITTED TO THE HOSPITAL FOR PAIN AND SUBSEQUENTLY EXPIRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY WITH HIATAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED BLOOD LOSS ON AN UNSPECIFIED DATE. IN ADDITION, APPROXIMATELY 2 WEEKS POST-OPERATIVELY, THE PATIENT WAS READMITTED TO THE OR AND HAD PART OF HER STOMACH AND BOWEL REMOVED FOR AN UNKNOWN REASON. THE INITIAL REPORTER WAS UNSURE IF THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2017. ON 06/07/2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AN ISI CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SITE'S OR DIRECTOR. SHE WAS UNABLE TO CONFIRM IF THE DV PROCEDURE WAS PERFORMED ON (B)(6) 2017. ACCORDING TO THE OR DIRECTOR, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THERE WERE ALSO NO REPORTS OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WENT SMOOTHLY AND WAS COMPLETED ROBOTICALLY. DUE TO UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND POST-OPERATIVE BLEEDING FROM AN UNKNOWN SOURCE, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. THE CSR DID NOT KNOW WHY PARTS OF THE PATIENT'S STOMACH AND BOWEL WERE REMOVED. 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: IT WAS INITIALLY REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AND UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE. THE INITIAL REPORTER DID NOT KNOW IF THE SECONDARY OPERATION WAS RELATED TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ON 05/09/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: THE CSR WAS PRESENT DURING THE ENTIRE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. A PROCTOR WAS PRESENT DURING THE PROCEDURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WERE NO REPORTED ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE GJ AND JJ TUBES LOOKED GOOD. HOWEVER, THE SURGEON REPORTEDLY VOICED CONCERNS REGARDING THE POUCH THAT HE HAD MADE. THE CSR REITERATED THAT THERE WAS NO ALLEGATION FROM THE SURGEON OR SURGICAL STAFF THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUME

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 MITRAL VALVE REPAIR PROCEDURE, PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED INTRA-OPERATIVE COMPLICATIONS. AFTER AN INITIAL ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, UNSPECIFIED LEAKAGES WERE OBSERVED. AS A RESULT, THE SURGICAL STAFF RE-OPENED AND RE-SUTURED AROUND THE VALVE. AFTER A SECOND ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, LEAKAGES WERE STILL OBSERVED. AS A RESULT, THE SURGICAL STAFF DECIDED TO CHANGE A VALVE FOR A NEW ONE. AFTER A THIRD ECHOGRAPHIC CONTROL WAS PERFORMED INTRA-OPERATIVELY, LEAKAGES WERE STILL FOUND AND THE DECISION WAS MADE TO CONVERT THE DA VINCI-ASSISTED SURGICAL PROCEDURE TO A STERNOTOMY PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY, THE INITIAL REPORTER LEFT THE OR ROOM. AT THIS TIME, THE ROOT CAUSES OF THE INTRA-OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE WAS NO ALLEGATION DURING THE SURGICAL PROCEDURE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES HAD OCCURRED. APPROXIMATELY NINE HOURS AFTER THE CASE WAS CONVERTED TO OPEN SURGERY, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN UNSPECIFIED REASON. AT THIS FACILITY, THE PATI

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 INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT'S INTESTINES WERE ALLEGEDLY NICKED AND THE PATIENT PASSED AWAY WITHIN 48 HOURS FROM SEPTIC POISONING. ON (B)(6)2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THE DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE WAS COMPLETED WITH NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. DURING THE SURGICAL PROCEDURE, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS REPORTED. TO HIS RECOLLECTION, THE CSR INDICATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY THE SURGICAL PROCEDURE WAS PERFORMED. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL FOR AN UNKNOWN REASON. THE CSR SPOKE TO THE SURGEON ABOUT THE REPORTED EVENT. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT THE PATIENT SUPPOSEDLY SUSTAINED A BOWEL INJURY AND THEN PASSED AWAY. THE SURGEON DID NOT INITIALLY ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING

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 TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2017. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT EXPIRED AS A RESULT OF UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS.

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 PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY EXPIRED. THERE WERE NO REPORTS OF ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. ON 03/24/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. DURING THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM AN UNSPECIFIED VESSEL. AS A RESULT OF THE BLEEDING, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY. AT THAT TIME THE CSR REPORTEDLY LEFT THE OR. AFTER THE EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON. ACCORDING TO THE CSR, THERE WAS NO ALLEGATION FROM THE SURGEON THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE BLEEDING AND SUBSEQUENT DEATH. THE PATIENT REPORTEDLY EXPIRED ON THE OR TABLE.

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 FIVE DAYS AFTER COMPLETION OF AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE PERFORMED IN (B)(6) 2016, THE PATIENT EXPERIENCED POST-OPERATIVE HEMORRHAGING IN HER ROOM. THE CAUSE AND SOURCE OF THE HEMORRHAGING IS CURRENTLY UNKNOWN. CARDIAC MASSAGES WERE ADMINISTERED TO THE PATIENT A LITTLE OVER FOUR HOURS IN HER ROOM. ONCE THE PATIENT WAS STABLE, THE PATIENT WAS TAKEN TO THE OR. HOWEVER, THE SURGICAL STAFF WAS UNABLE TO SAVE THE PATIENT. THE PATIENT REPORTEDLY EXPIRED FIVE DAYS AFTER UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION IS UNKNOWN: THE ACTUAL DATE THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, WHAT SPECIFIC TYPE OF SURGICAL PROCEDURE WAS PERFORMED, WHAT DATE THE HEMORRHAGE WAS IDENTIFIED, AND WHAT DATE THE PATIENT EXPIRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY THAT WAS NOT IDENTIFIED INTRA-OPERATIVELY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS INFORMED ABOUT THE REPORTED EVENT FROM THE SURGEON'S 1ST ASSIST. THE CSR WAS NOT PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THERE WAS ALSO NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON AN UNKNOWN DATE. ON (B)(6) 2016, THE PATIENT RETURNED TO THE HOSPITAL AND WAS SEPTIC. AN EXPLORATORY LAPAROTOMY WAS PERFORMED ON THE PATIENT AND A HOLE WAS FOND ON THE TRANSVERSE COLON. PER THE CSR, THE SURGEON INFORMED HIM THAT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, HE WAS NOWHERE NEAR WHERE THE BOWEL INJURY WAS LOCATED. ACCORDING TO THE CSR, THE SITE DOES NOT KNOW WHAT CAUSED THE BOWEL INJURY. HOWEVER, THE CSR INDICATED THAT THE SITE IS SUSPECTING THAT THE BOWEL INJURY OCCURRED DURING INSERTION OF AN

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 INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS READMITTED TO THE HOSPITAL TWO TIMES. THE DATES OF THE READMISSIONS ARE UNKNOWN. IN ADDITION, THE REASONS FOR THE READMISSIONS ARE UNKNOWN. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT PASSED AWAY. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE UNRECORDED DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. AFTER THE PATIENT PASSED AWAY ON AN UNSPECIFIED DATE, AN AUTOPSY WAS PERFORMED AND 3 SEPARATE PUNCTURE HOLES WERE FOUND ON THE PATIENT'S BOWEL. THE CSR DID NOT KNOW THE CAUSE OF THE BOWEL DEFECTS OR THE PATIENT'S 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: 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 — 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 — 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 — 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 — 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: 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 — 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 — 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 — 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 — 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 NEPHRECTOMY PROCEDURE, THE SURGEON ENCOUNTERED A LARGE AMOUNT OF BLEEDING AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, IT IS UNCLEAR IF THE SURGEON TORE THE RENAL ARTERY OR ACTUALLY GOT INTO THE AORTA. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS INFORMED BY MULTIPLE SOURCES AT THE SITE THAT THE PATIENT HAD PASSED AWAY AFTER BEING MOVED TO THE HOSPITAL FLOOR.

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 PARACOLOSTOMY HERNIA REPAIR PROCEDURE ON (B)(6) 2015. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED A PERFORATED SMALL BOWEL DURING THE SURGICAL PROCEDURE THAT WENT UNTREATED FOR SEVERAL DAYS BEFORE HIS DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE PLAINTIFF'S ATTORNEY, THE SURGEON ENCOUNTERED MULTIPLE MASSIVE ADHESIONS DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE PATIENT REPORTEDLY EXPERIENCED EXCRUCIATING ABDOMINAL PAIN THAT BEGAN THE EVENING THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT WAS ADMINISTERED MULTIPLE UNSPECIFIED PAIN MEDICATIONS. POST-OPERATIVELY, THE PLAINTIFF'S ATTORNEY NOTED THAT THE PATIENT DEVELOPED CLINICAL AND LABORATORY SIGNS COMMONLY REFERRED TO AS RED FLAGS THAT WERE CONSISTENT WITH PERITONITIS, SEPSIS AND SEPTIC SHOCK, INCLUDING WITHOUT LIMITATION, ABDOMINAL PAIN, ABDOMINAL TENDERNESS, INCREASED WHITE BLOOD COUNT WITH BANDEMIA, PROGRESSIVE TACHYCARDIA, PROGRESSIVE HYPOXMIA, INCREASED RESPIRATORY RATE, RESPIRATORY

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 TORS PROCEDURE, THE PATIENT PASSED A FEW DAYS LATER. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. ACCORDING TO THE CSR, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS DURING THE DA VINCI SURGERY. THE CSR INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2015 AND AN AUTOPSY WAS TO BE 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 REPORTED THAT DURING A DA VINCI ASSISTED MITRAL VALVE PROCEDURE, THE SURGEON EXPERIENCED DOUBLE VISION WITH THE 30 DEGREE ENDOSCOPE. THE INTUITIVE SURGICAL INC. (ISI)TECHNICAL SUPPORT ENGINEER (TSE) PROVIDED TROUBLESHOOTING STEPS INCLUDING ASSISTANCE IN RECALIBRATING A REPLACEMENT 30 DEGREE ENDOSCOPE; HOWEVER, THERE WAS NO CHANGE IN VISION. THE SURGEON DECIDED TO COMPLETE THE PROCEDURE USING TRADITIONAL OPEN SURGICAL TECHNIQUES. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

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 LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 2. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INTUITIVE SURGICAL EMPLOYEE WHO INITIALLY REPORTED THE COMPLAINT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ON (B)(6) 2015, A PATIENT WITH A BIG, LATE T3/T4 GRADE TUMOR LOCATED IN THE LOWER RECTUM UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE IN ORDER TO REMOVE THE TUMOR. DURING THE PROCEDURE, A SMALL ANASTOMOTIC LEAK WAS IDENTIFIED AFTER A LEAK TEST WAS PERFORMED. THE SURGEON WAS NOT SURE WHAT CAUSED THE ANASTOMOTIC LEAK. IT WAS INDICATED THAT A NON-ISI STAPLER INSTRUMENT HAD BEEN USED TO CREATE THE ANASTOMOSIS. THE PATIENT'S ABDOMEN WAS CLEANED WITH BETADINE AND A PROTECTIVE ILEOSTOMY WAS PLACED. ANTIBIOTICS WERE ALSO ADMINISTERED. ACCORDING TO THE INITIAL REPORTER, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THE INITIAL REPORTER ALSO INDICATED THAT THERE WERE NO ISSUES WITH ANESTHESIA. AFTER THE TUMOR WAS REMOVED AND THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS

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)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER (B)(6)) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON (B)(6) 2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FROM 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 (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE ARCHIVIO ITALIANO DI UROLOGIA E ANDROLOGIA (2015; 87, 1) JOURNAL ARTICLE TITLED, COMPARING ROBOTIC, LAPAROSCOPIC AND OPEN CYSTECTOMY: A SYSTEMATIC REVIEW AND META-ANALYSIS. (THOMAS FONSEKA ET AL., 2015). WITHIN THE ARTICLE, A STATEMENT IS NOTED ALLEGING THAT 3 PATIENTS REPORTEDLY EXPERIENCED MAJOR COMPLICATIONS AFTER UNDERGOING A DA VINCI® RADICAL CYSTECTOMY PROCEDURE AND SUBSEQUENTLY PASSED AWAY. IN THE STUDY CHARACTERISTICS SECTION, THE FOLLOWING IS STATED, 8.51% OF PATIENTS UNDERGOING RARC HAD MAJOR COMPLICATIONS WITH 3 DEATHS (0.412%) WITHIN 90 DAYS POST-OPERATIVELY.

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 SURGEON INJURED THE PATIENT'S VENA CAVA DURING HILAR DISSECTION. THE PATIENT REPORTEDLY BLED OUT ON THE TABLE AND PASSED AWAY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT CAME BACK TO THE HOSPITAL AND SUBSEQUENTLY PASSED AWAY DUE TO SEPSIS. A PHYSICIAN'S ASSISTANT (PA) FROM THE SITE INDICATED THAT AN AUTOPSY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A BOWEL INJURY. THE PA INDICATED THAT THE BOWEL INJURY MIGHT HAVE OCCURRED DURING INITIAL PORT PLACEMENT OF THE DA VINCI SURGICAL PROCEDURE. THE PA ALSO INDICATED THAT IT WAS THE FIRST TIME THAT THE FELLOW HAD INSERTED A TROCAR. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HE INDICATED THAT THE SITE UTILIZES AN ETHICON TROCAR DURING CAMERA PORT PLACEMENT AND AN AIRSEAL TROCAR FOR THE ASSIST PORT PLACEMENT. IN ADDITION, THE SITE UTILIZES ISI TROCARS FOR PLACEMENT OF THE PORT FOR THE ROBOTIC INSTRUMENTS AND ARMS. HE DID NOT KNOW WHICH TROCAR MIGHT HAVE POSSIBLY CAUSED THE BOWEL INJURY. ON (B)(6) 2015, ISI ALSO CONTACTED THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT DURING A PART OF THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE CTA, THE PA WAS PRESENT DURING THE SURGICAL PROCEDURE AND THERE WE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON (B)(6) 2015 AND ALLEGEDLY SUSTAINED UNSPECIFIED DAMAGES. THE PLAINTIFF'S ATTORNEY CLAIMED THAT IMMEDIATELY FOLLOWING SURGERY, THE PATIENT DEVELOPED A CARDIOPULMONARY FAILURE AND SUFFERED FROM BLEEDING WHICH LED TO HER DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS.

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 UNDERWENT A DA VINCI MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2015 AND PASSED AWAY ON AN UNSPECIFIED DATE/TIME. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S DEMISE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DATE OF DEATH = (B)(6) 2015. THIS MDR SUBMISSION IS ACTUALLY A FOLLOW-UP #1 MDR TO MFR. REPORT # 2955842-2015-01059 (PATIENT IDENTIFIER # (B)(6)) WHICH WAS INITIALLY SUBMITTED ON 08/03/2015. ON 11/07/2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE DATE OF THE PATIENT'S DEMISE (NOTE: THE COMPLAINT HANDLING SYSTEM THAT WAS USED TO SUBMIT THE INITIAL MDR IS NO LONGER AVAILABLE FOR SUBMITTING EMDRS).

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) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED NOTIFICATION OF A BOSTONHERALD.COM ARTICLE TITLED, ROBOTS IN THE O.R.: SUIT TARGETS ROBOTIC SURGERY RISKS AND DATED NOVEMBER 20, 2014. ACCORDING TO THE ARTICLE, A PATIENT AGREED TO UNDERGO A DA VINCI HYSTERECTOMY ON AN UNSPECIFIED DATE IN THE SPRING OF 2009. THE ARTICLE INDICATES, THE SURGERY RESULTED IN A TEAR IN HER SMALL INTESTINE..., AND THE PATIENT, HAD SEPSIS, AND HAD SUBSEQUENT SURGERIES TO REPAIR THE TISSUE. SHE SPENT MONTHS IN AND OUT OF THE HOSPITAL. THE ARTICLE ALSO STATES, BECAUSE OF THE COMPLICATIONS, SHE COULDN'T COMPLETE CHEMOTHERAPY AND NEVER STARTED RADIATION TREATMENT. SHE DIED ON (B)(6) 2010. THERE IS NO CLAIM WITHIN THE ARTICLE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF A DA VINCI COLON RESECTION PROCEDURE THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. UPON FOLLOW UP WITH THE SITE, THE RISK MANAGER AT THE HOSPITAL STATED THAT THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS, HOWEVER, RETURNED TO THE HOSPITAL ON (B)(6) 2014 WITH A FEVER AND REPORTED FATIGUE. NO ISSUES WERE IDENTIFIED AND NO TREATMENT WAS PROVIDED AND THE PATIENT WAS RELEASED HOME. THE PATIENT WAS FOUND EXPIRED IN HER HOME ON (B)(6) 2014. PER THE RISK MANAGER, NOTHING REGARDING THE PATIENTS OUTCOME LED HER TO BELIEVE THAT THE DA VINCI SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S OUTCOME. AS OF THE DATE OF THIS REPORT THE AUTOPSY RESULTS ARE PENDING.

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 UNDERGOING A DA VINCI TOTAL PROCTOCOLECTOMY WITH J-POUCH PROCEDURE ON (B)(6) 2014, THE PATIENT BLED OUT, HAD ORGAN FAILURE DUE TO BLOOD LOSS, AND PASSED AWAY ON (B)(6) 2014. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGICAL PROCEDURE WAS PLANNED TO BE A COMBINATION OF A DA VINCI TOTAL PROCTOCOLECTOMY WITH J-POUCH AND TRADITIONAL LAPAROSCOPIC SURGERY. AFTER THE DA VINCI PORTION OF THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED, THE SURGEON FINISHED THE REMAINDER OF THE SURGERY VIA TRADITIONAL LAPAROSCOPIC SURGERY. NO INTRA-OPERATIVE COMPLICATIONS OR SIGNIFICANT BLEEDING WERE REPORTED DURING THE SURGERY. IN ADDITION, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY PASSED AWAY ON POST-OP DAY 10. THE INITIAL REPORTER INDICATED THAT HE SPOKE TO VARIOUS SURGEONS AT THE SITE REGARDING 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED SURGICAL PROCEDURE ON (B)(6) 2014. THE PLAINTIFF'S ATTORNEY ALLEGES THAT AS A RESULT OF UNDERGOING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT SUSTAINED SERIOUS AND PERMANENT BODILY INJURY AND ULTIMATELY PASSED AWAY ON (B)(6) 2014. ISI WAS NOT PROVIDED WITH THE DA VINCI OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS.

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 SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 1. DURING THE SURGICAL PROCEDURE, THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE SURGEON WAS HAVING ISSUES WITH CLIPS DISLODGING FROM A SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT DURING INSERTION THROUGH A CANNULA. TOWARDS THE END OF THE SURGICAL PROCEDURE, A CLIP INSTALLED ON THE SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FELL INSIDE THE PATIENT. THE SURGEON SPENT ABOUT 10 MINUTES SEARCHING FOR THE CLIP USING A SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT AND A SINGLE-SITE CROCODILE GRASPER INSTRUMENT. DURING THE PROCESS OF SEARCHING FOR THE CLIP, THE SURGEON LACERATED THE LOWER LOBE OF THE PATIENT'S LIVER AS HE WAS MANIPULATING OR LIFTING THE ORGAN WITH THE SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT. THE SURGEON WAS ABLE TO CONTROL BLEEDING THAT ENSUED BY CAUTERIZING THE LACERATION. THE SURGEON THEN PROCEEDED TO COMPLETE THE DA VINCI SURGICAL PROCEDURE. PRIOR TO COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT ALSO UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AND UNSPECIFIED HERNIA REPAIR PROCEDURE. ACCORDING TO 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: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI RIGHT TRANSVERSE COLECTOMY PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT (ED) 2 WEEKS POST-OPERATIVELY WITH SYMPTOMS OF A FEVER. THE PATIENT SUBSEQUENTLY PASSED AWAY WITH UNKNOWN ETIOLOGY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO SIGNS OF AN ADVERSE EVENT AT THE TIME OF SURGERY AND SHORTLY THEREAFTER. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING PART OF THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE CSR, HE WAS PRESENT DURING SETUP OF THE PROCEDURE AND UP UNTIL ABOUT HALF WAY THROUGH COMPLETION OF THE SURGERY. THE CSR INDICATED THAT DURING THE PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ISSUE AT ONE POINT WHERE PATIENT SIDE MANIPULATOR (PSM) 1 DID NOT RECOGNIZE AN INSTRUMENT. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE CSR STATED THAT THE SURGICAL STAFF SWAPPED INSTRUMENTS BETWEEN THE PSMS AND EVERYTHING WORKED PROPERLY FROM THAT POINT ON. DURING THE TIME THE CSR WAS PRESENT DURING THE PROCEDURE, THERE WERE NO INTRA-OPERATIV

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 RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 7. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT BEGAN TO REFUSE HIS MEDICATIONS AND HAD PULLED OUT HIS NG TUBE PRIOR TO PASSING AWAY. SHE ALSO INDICATED THAT POSSIBLY THE PATIENT ASPIRATED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS PRESENT DURING PARTS OF THE DA VINCI SURGICAL PROCEDURE. DURING THE TIMES THAT HE WAS PRESENT, THE CSR INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. THE CSR STATED THAT AN INITIAL AUTOPSY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE DEVELOPED ILEUS. IN ADDITION, THE PATIENT'S STAPLE LINE HAD RUPTURED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER STATED THAT BASED ON THE OPERATIVE REPORT AND THE SITE'S PREL