da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DAVINCI ROBOT CUT MY JEJUNUM THROUGH AND THROUGH BURNED MY SIGMOID COLON DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) CLINIC PERFORMED BY DR (B)(6). THERE WERE NO TROCARS INSERTED WHERE THERE WERE INJURIES. I BELIEVE THE FDA ERRED IN ALLOWING THIS DEVICE TO CONTINUE TO BE USED IN THE MEDICAL. I BELIEVE IT IS NOT SAFE AND THE PART ISSUES HAVE NOT BEEN REMEDIED. I BELIEVE THE FDA DID NOT AND DOES NOT CONTINUE TO MONITOR AND REGULATE INTUITIVE SURGICAL AS THERE CONTINUES TO BE INJURIES AND DEATHS SURROUNDING THE DAVINCI ROBOT. I ALSO BELIEVE THERE ARE VIOLATIONS AROUND ADVERSE EVENT REPORTING BASED ON THE FACT MY INJURIES WERE NOT REPORTED AS WELL AS A NUMBER OF INDIVIDUALS I HAVE TALKED TO WHO HAVE ALSO SUFFERED INJURIES FROM THE DAVINCI ROBOT. PER PREVIOUS COMMITMENTS FROM INTUITIVE SURGICAL TO FDA, PLEASE ADVISE ON THE FOLLOWING: INTUITIVE USES A (B)(4) AVIATION MFR TO MAKE SOME OF THEIR COMPONENTS IN THE DAVINCI ROBOT NAMED EASTON. DO THEY STILL CONTINUE TO USE THIS 3RD PARTY AND WHY THEY NEVER TESTED THE MATERIAL IN THE TUBES. ALSO, WHAT TYPE OF MATERIALS ARE USED AND HOW IS THIS MONITORED AND REGULATED. HISTORICALLY, INTUITIVE KNEW THE COMPOSITE MATERIAL WAS NOT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ENDOWRIST STAPLER SHEATH (REF: (B)(4)) USED IN THE DA VINCI XI STAPLER 45 (REF: (B)(4)) TO COVER THE END SHAFT OF THE STAPLER HANDPIECE LOOKS LIKE AN ORIGINAL OEM PART THAT HAS ALWAYS BEEN A PART OF THE STAPLER. THERE WAS NO CLEAR WARNING OR BRIGHT NOTICE TO INSTRUCT USERS TO REMOVE THE SHEATH PRIOR TO SENDING TO STERILE PROCESSING DEPARTMENT (SPD) FOR REPROCESSING. THE BLACK PIECE OF THE SHEATH HAPPENED TO DISENGAGE FROM THE OTHER PART OF THE SHEATH AND WAS LEFT ON THE INSTRUMENT DURING THIS EVENT. THE SPD TEAM DID NOT NOTICE AND THE HANDPIECE WAS STERILIZED WITH THE PART OF THE SHEATH INTACT. THE INSTRUMENT WAS THEN USED ON A CASE. IT WAS DISCOVERED THE REMAINING PIECE WAS NOT PART OF THE STAPLER HANDPIECE WHEN ANOTHER SHEATH WAS INSERTED AND THAT THE STAPLER WOULD NOT FIT THE CANNULA. AT THIS POINT, THE INSTRUMENT BECOMES CONTAMINATED WITH BIOBURDEN (PART OF THE REMAINING SHEATH) AND THE WOUND CLASSIFICATION CHANGES FROM CLEAN TO CONTAMINATED. REQUEST THAT CHANGES TO THE SHEATH BE MADE TO WARN USERS THE SHEATH MUST BE REMOVED AFTER A CASE TO INCLUDE A RED WARNING "DISPOSE AFTER USE" OR CHANGING ENTIRE COLOR TO MAKE IT STAND OUT.

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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED VIA SOCIAL MEDIA THAT AS A RESULT OF UNDERGOING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT ALLEGED THAT HER INSIDES WERE BURNED AND HER BOWEL PROLAPSED. THE PATIENT ALSO STATED, MY PRIZED ORGAN IS FOREVER DESTROYED BY A FAULTY TIP AND NOT 93'S OF BONES IS WORTH (B)(6)? IT IS UNCLEAR WHAT SPECIFIC ORGAN THE PATIENT WAS REFERRING TO AND WHAT TYPE OF DAMAGE/INJURY WAS SUSTAINED. IT IS ALSO UNCLEAR WHAT SPECIFIC INSTRUMENT OR ACCESSORY WAS ALLEGEDLY FAULTY. 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 SURGEON THAT DURING A SURGICAL PROCEDURE OF "ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY" THAT THE SPRING BROKE IN DA VINCI FENESTRATED BIPOLAR FORCEPS. THE DEVICE WAS SWITCHED OUT AND NO HARM WAS REPORTED TO THE PATIENT. NO FURTHER DOCUMENTATION WAS GIVEN REFERENCE THE SPRING BREAK ON THE FORCEPS AND THE DEVICE IS AVAILABLE FOR REVIEW.

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 — 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 LOW ANTERIOR RESECTION PROCEDURE, AN UNSPECIFIED INSTRUMENT INSTALLED ON ARM 3 STOPPED RESPONDING. AT THAT TIME, THE UNSPECIFIED INSTRUMENT WAS GRASPING FATTY TISSUE. IN ORDER TO REMOVE THE INSTRUMENT, THE SURGEON MADE THE DECISION TO DISSECT THE GRASPED TISSUE. WHEN THE EVENT OCCURRED, THE SURGICAL STAFF REPORTEDLY DID NOT ATTEMPT TO USE AN INSTRUMENT GRIP RELEASE TOOL. ACCORDING TO THE DA VINCI SI USER MANUAL, THE EMERGENCY GRIP RELEASE MECHANISM FACILITATES REMOVAL OF AN INSTRUMENT IN THE EVENT OF A SYSTEM FAULT. FOR EXAMPLE, IF THE INSTRUMENT TIPS ARE HOLDING TISSUE, THE EMERGENCY GRIP RELEASE ALLOWS THE PATIENT SIDE OPERATOR TO MANUALLY RELEASE THE GRIP. THE DA VINCI INSTRUMENT AND ACCESSORIES USER MANUAL STATES THE FOLLOWING GENERAL PRECAUTIONS AND WARNINGS: WARNING: DO NOT PERFORM GRIP RELEASE ON A NON-FAULTED SYSTEM WITHOUT FIRST PRESSING THE EMERGENCY STOP BUTTON. FAILURE TO OBSERVE THIS WARNING MAY RESULT IN UNINTENDED INSTRUMENT MOTION OR DAMAGE TO THE GRIP RELEASE MECHANISM. WARNING: IN CASE OF SYSTEM FAILURE WHILE THESE INSTRUMENTS ARE GRASPING TISSUE, THE GRIPS CAN BE MANUALLY OPENED BY INSERTING THE GRIP RELEASE TOOL IN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVED REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2017. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2011 - (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 BY SURGEON THAT DURING A DA VINCI XI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT LOOKED LIKE A WIRE WAS BROKEN. THE SURGEON ALSO REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE. THE DEVICE HAD TO BE SWITCHED OUT. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

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 — 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 SACROCOLPOPEXY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A NON-RECOVERABLE SYSTEM ERROR CODE 15. DURING THE REPORTED EVENT, THE SURGICAL STAFF USED AN INSTRUMENT RELEASE KIT (IRK) TO REMOVE THE PROGRASP FORCEPS INSTRUMENT. AFTER REMOVING ALL OF THE ROBOTIC INSTRUMENTS, THE SURGICAL STAFF POWER CYCLED THE DA VINCI SURGICAL SYSTEM. AFTER THE DA VINCI SURGICAL SYSTEM WAS REBOOTED, THE SYSTEM POWERED UP NORMALLY AND THE SURGEON WAS ABLE TO CONTINUE WITH THE SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT SUSTAINED UNSPECIFIED DAMAGE TO THE SIGMOID COLON DURING THE REPORTED EVENT. HOWEVER, THE ROOT CAUSE AND SEVERITY OF THE BOWEL INJURY ARE UNKNOWN. ON APRIL 25, 2017, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REVIEWED THE SITE'S SYSTEM LOGS AND VERIFIED THAT A SYSTEM ERROR CODE 15 OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE. THE FSE REPLACED REMOTE ARM CONTROLLER (RAC2) AS A PRECAUTION AND MOVED THE RAC2 TO THE RAC1 POSITION. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIE

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 XZI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPRING WAS BROKEN AFTER IT WAS HOOKED TO ROBOT. THE REPORT REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE WITH THE SPRING PROTRUDED. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

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 — 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 XI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPRING WAS BROKEN AFTER IT WAS HOOKED TO ROBOT. THE REPORT REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE WITH THE SPRING PROTRUDED. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

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 XI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPRING WAS BROKEN AFTER IT WAS HOOKED TO ROBOT. THE REPORT REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE WITH THE SPRING PROTRUDED. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR NOTICED FRAYED WIRE STICKING OUT AND THE INSTRUMENT WAS NOT WORKING PROPERLY. REMOVED THE INSTRUMENT FROM USE.

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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A GASTRIC PERFORATION ON POST-OPERATIVE DAY 1. PRIOR TO UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT HAD ALSO UNDERGONE A DIAGNOSTIC LAPAROSCOPY PROCEDURE WITH ADHESIOLYSIS. A SURGEON REPAIRED THE GASTRIC PERFORATION VIA OPEN SURGERY AND HAD TO REMOVE MESH. AFTER GOING HOME, THE PATIENT REPORTEDLY DEVELOPED AN UNSPECIFIED EMBOLISM AND GI BLEED. 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: 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 — 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 PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE PULMONARY ARTERY. AT THE TIME THE BLEEDING WAS IDENTIFIED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY HAD OCCURRED. WHEN THE EVENT OCCURRED, THE SURGEON WAS ABLE TO CONTROL THE BLEEDING BY USING TACHOSIL SPONGES. THE PULMONARY ARTERY WAS REPORTEDLY SEWN. NO BLOOD TRANSFUSIONS WERE ADMINISTERED. IT WAS NOTED THAT DUE TO THE COMPLEXITY AND LENGTH OF THE SURGICAL PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY. THE SURGEON REPORTEDLY FELT MORE SECURE COMPLETING THE SURGICAL PROCEDURE VIA OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON WAS ABLE TO COMPLETE THE SURGICAL PROCEDURE 10-15 MINUTES AFTER THE CASE WAS CONVERTED TO OPEN SURGERY. IT IS UNCLEAR IF THE SURGEON REPAIRED THE PULMONARY ARTERY BEFORE OR AFTER THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE PATIENT EXPERIENCED AN UNSPECIFIED RESPIRATION ISSUE POST-OPERATIVELY. HOWEVER, IT WAS REPORTED THAT THE RESPIRATION ISSUE WAS UNRELATED TO THE INTRA-OPERATIVELY BLEEDING EXPERIENCED BY THE P

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 SINGLE-SITE DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2017, THE SURGEON EXPERIENCED A LOT OF RESISTANCE WITH INSTRUMENT MOVEMENT. ON 02/07/2017, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. DURING THE FIELD EVALUATION, THE FSE REPORTEDLY SPOKE TO THE SITE'S ROBOTICS COORDINATOR REGARDING THE REPORTED EVENT. THE ROBOTICS COORDINATOR CLAIMED THAT DUE TO RESISTANCE WITH THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND RESTRICTED MOTION, THE SURGEON HAD TO TARGET BELOW THE ANATOMY. THE ROBOTICS COORDINATOR CLAIMED THAT THERE WAS LIMITED SPACING AND MOVEMENT. ON 02/09/2017, THE ISI CLINICAL SALES REPRESENTATIVE (CSR) INDICATED THAT THE PATIENT CAME BACK TO THE HOSPITAL WITH A POST-OPERATIVE BILE LEAK AND WAS GOING THROUGH UNSPECIFIED TESTING. THE CSR INDICATED THAT THE SURGEON PERFORMED TWO SUBSEQUENT DA VINCI-ASSISTED SURGICAL PROCEDURES THE DAY THE REPORTED EVENT OCCURRED AND THERE WERE NO REPORTED ISSUES DURING

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) 2016 - (B)(6) 2017. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2008 - (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: THE HOSP USED A DA VINCI MACHINE AND IT TORE MY LEFT ROTATOR CUFF, STILL BEING TESTED TO SEE IF CANCER IS GONE ON MY RIGHT KIDNEY. FDA SAFETY REPORT ID# (B)(4).

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 BILIARY PANCREATIC DIVERSION PROCEDURE, THE PATIENT HAD AN ARTERIO-VENOUS LESION, A CADIERE FORCEPS INSTRUMENT WAS USED AS A CLAMP, AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. IN ORDER TO REMOVE THE CADIERE FORCEPS INSTRUMENT, THE SURGICAL STAFF USED AN INSTRUMENT RELEASE KIT (IRK). ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON INDICATED THAT THE PATIENT SUSTAINED AN UNSPECIFIED INJURY AND HE USED THE CADIERE FORCEPS INSTRUMENT TO CONTROL BLEEDING FROM THE CAVERNOMA PORTAL VEIN. THE SURGEON DID NOT PROVIDE DETAILS REGARDING THE INJURY SUSTAINED BY THE PATIENT OR THE CAUSE OF THE BLEEDING FROM THE BLOOD VESSEL. DUE TO THE UNSPECIFIED INJURY, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI-ASSISTED SURGICAL PROCEDURE TO OPEN SURGERY. DURING THE CONVERSION TO OPEN SURGERY, THE SURGICAL STAFF WAS ABLE TO UNDOCK THREE OF FOUR ROBOTIC ARMS THAT WERE INSTALLED ON THE PATIENT SIDE CART (PSC). HOWEVER, THE SURGICAL STAFF HAD DIFFICULTY OPENING THE JAWS OF A CADIERE FORCEPS INSTRUMENT THAT WAS INSTALLED ON THE FO

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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HYSTERECTOMY WITH DA VINCI ROBOT AT (B)(6) HOSPITAL FOR 3.75 HOURS. WOKE WITH GRADE 4 ANNULAR TEAR IN L5-S1 LUMBAR DISC, CAUSING IMMEDIATE SEVERE PAIN AND REQUIRING ARTIFICIAL DISC REPLACEMENT 7 MONTHS LATER.

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 THORACOTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2016, THE PATIENT WAS IDENTIFIED TO HAVE A HEMOTHORAX ON POST-OPERATIVE DAY 1. THE SURGEON INDICATED THAT THE INTERNAL MAMMARY ARTERY (IMA), WHICH WAS HARVESTED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, WAS FOUND TO BE BLEEDING. THE SURGEON HAD TO PLACE SUTURES ON THE IMA IN ORDER TO CONTROL THE BLEEDING. THE SURGEON COULD NOT CONFIRM A ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION. HOWEVER, THE SURGEON INITIALLY ATTRIBUTED THE POST-OPERATIVE COMPLICATION TO POSSIBLE SURGEON-ERROR. ACCORDING TO THE SURGEON, THE PATIENT HAS BEEN DOING VERY WELL SINCE THEN. THE SURGEON STATED THAT A POSSIBLE CAUSE OF THE POST-OPERATIVE COMPLICATION WAS DUE TO A SETTING ON THE ERBE GENERATOR WHICH IS INTEGRATED WITH THE DA VINCI XI SURGICAL SYSTEM. THE SURGEON EXPLAINED THAT THE INTEGRATED ERBE GENERATOR DOES NOT GIVE THE OPTION OF INCREASING THE SETTINGS IN SMALLER INCREMENTS WHICH WOULD HELP WITH PURE COAGULATION. DURING THE SURGICAL PROCEDURE, THE SURGEON STATED THAT HE HAD SET THE ERBE GENERATOR AT 2 BUT WOULD HAVE PREFERRED TO SET IT AT 1.5 WHICH IS NOT AN AVAILABL

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 TOTAL BENIGN HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ENERGY WAS ALLEGEDLY CUTTING TOO MUCH TISSUE. THE INITIAL REPORTER CLAIMED THAT BIPOLAR AND MONOPOLAR ENERGY WAS NOT STOPPING AND WAS BURNING THROUGH TOO MUCH TISSUE. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S OR ASSISTANT DIRECTOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE OR ASSISTANT DIRECTOR STATED THAT THE ENERGY TRAVELED DURING THE PROCEDURE, WHICH RESULTED IN A THERMAL BURN ON A FALLOPIAN TUBE AND THE SIGMOID COLON ADJACENT TO IT. IT WAS CONFIRMED THAT THERE WAS NO ARCING SEEN BY THE SURGEON OR THE BEDSIDE ASSISTANTS; HOWEVER, WHEN THE FALLOPIAN TUBE WAS MOVED THE SURGEON SAW EVIDENCE OF A BURN ON IT AND ON THE SIGMOID COLON. AT THIS TIME THE SURGEON INSPECTED THE SIGMOID COLON AND FOUND IT HAD A LEAK, THE SURGEON APPLIED SUTURES TO STOP THE LEAK. PHOTOGRAPHIC IMAGES OF THE PATIENT'S INJURY WERE REVIEWED BY THE HOSPITAL STAFF AND IT WAS REPORTED THAT THERE WAS A LARGE DISTANCE BETWEEN THE INJURED TISSUE AND THE INSTRUMENTS USED. THE SITE REPORTED THAT THE INSTRUMENTS ARE ALWAYS EXAMINED PRIO

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 10/18/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE OPEN MEDICINE JOURNAL ARTICLE TITLED, MALFUNCTIONS OF ROBOTIC SYSTEM IN SURGERY: ROLE AND RESPONSIBILITY OF SURGEON IN LEGAL POINT OF VIEW (FERRARESE, ET AL., 2016). THE PURPOSE OF THE JOURNAL ARTICLE WAS TO ESTIMATE THE IMPACT OF DEVICE MALFUNCTIONS IN ROBOTIC SURGERY AND ITS CONSEQUENT LEGAL IMPLICATIONS. WITHIN THE ARTICLE, THE FOLLOWING IS STATED: FROM A RS MALFUNCTION, 16 CAUSED PATIENT DAMAGE, OF WHICH 13 WERE MILD AND RESOLVED WITHOUT SEQUELAE, AND 3 WERE COMPLEX, INCLUDING AN EXTERNAL ILIAC VEIN LESION, ILEAL PERFORATION, AND URETHRAL LESION. THE LATTER WERE TREATED INTRA-OPERATIVELY WITH DIRECT ILIAC VEIN AND ILEAL SUTURE AND REIMPLANTATION OF THE URETHRAL LESION. NO FURTHER INFORMATION WAS PROVIDED WITHIN THE ARTICLE REGARDING THE OPERATIVE COMPLICATIONS.

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 PARATHYROID GLAD SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS. THE PATIENT'S SPOUSE CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE AND STATED THAT HIS WIFE HAD NERVE DAMAGE AND ALMOST LOST HER VOICE. THE SPOUSE FURTHER STATED THAT NOT ALL THE PARATHYROID GLANDS WERE REMOVED. ON 4/4/2017, ISI RECEIVED ADDITIONAL INFORMATION CONFIRMING THE DATE OF THE PROCEDURE. ON 4/10/2017 ISI RECEIVED ADDITIONAL INFORMATION FROM THE SURGEON WHO STATED THAT THERE WERE NO MALFUNCTION OF THE ISI SYSTEM, INSTRUMENT, OR ACCESSORIES. NO FURTHER DETAILS HAVE BEEN OBTAINED AS OF DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) 2 ALLEGEDLY MOVED ON ITS OWN WITH A PERMANENT CAUTERY HOOK INSTRUMENT INSTALLED. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE EVENT REPORTEDLY OCCURRED WHILE THE SURGEON WAS WAITING FOR INSTRUMENT REMOVAL. AS A RESULT, THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT INJURED THE PATIENT'S LIVER AND BLEEDING ENSUED. AFTER THE SURGEON CONTROLLED THE BLEEDING USING CAUTERY WITH THE SAME PERMANENT CAUTERY HOOK INSTRUMENT, THE SURGICAL STAFF PROCEEDED WITH THE SURGICAL PROCEDURE. WHEN THE EVENT OCCURRED, THE INITIAL REPORTER AND SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR SUPPORT. THE TSE INFORMED THE INITIAL REPORTER OF THE POSSIBLE CAUSES OF THE PSM DRIFTING. THE INITIAL REPORTER WAS GOING TO FOLLOW UP WITH THE SURGEON TO ENSURE HE REMOVES HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV) BEFORE RELEASING HIS GRIPS ON THE MASTER TOOL MANIPULATORS (MTMS). ON 12/05/2016, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING I

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 — 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 PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A DOUBLE-VISION ISSUE. THERE WERE NO REPORTS OF ANY PATIENT HARM ACCORDING TO THE INITIAL REPORTER, A ROBOTICS COORDINATOR. ON 12/15/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT. IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE SURGEON ENCOUNTERED A DOUBLE-VISION ISSUE WITH THE DA VINCI SI SURGICAL SYSTEM AND WAS EXPERIENCING MIGRAINE-LIKE SYMPTOMS. THE ISI CLINICAL SALES REPRESENTATIVE (CSR) USED A BACKUP CAMERA TO REPLACE THE CAMERA OF THE PATIENT SIDE CART (PSC). THE RISK MANAGER STATED THAT PATIENT HARM OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THE RISK MANAGER DID NOT HAVE ACCESS TO THE PATIENT'S RECORDS AND COULD NOT PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT HARM. ISI ALSO CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THE CSR INDICATED THAT HE WAS AT ANOTHER HOSPITAL AND IN THE MIDDLE OF ANOTHER DA VINCI-ASSISTED SURGICAL PROCEDURE WHEN THE ROBOTICS COORDINATOR CALLED HIM FOR ASSISTANCE WITH THE DOUBLE-VISION ISSUE. ACCORDING TO THE CSR, AT T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 JULY 2, 2016 - OCTOBER 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM FEBRUARY 2013 - APRIL 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: DURING ROBOTIC ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY A 1.5 CM PIECE OF PLASTIC SHEATH FROM THE MONOPOLAR CURVED SCISSORS CAME OFF OF THE DEVICE AND COULD NOT BE LOCATED. THE SCISSORS WERE NOTED TO HAVE A CRACK IN THE PLASTIC HOUSING DURING THE CASE. THE INSTRUMENT AND PORT WERE REMOVED AND A PIECE OF THE PLASTIC HOUSING WAS NOTED TO BE MISSING. THE SURGICAL TEAM INSPECTED THE SURGICAL FIELD AND THE ABDOMEN THROUGH BOTH THE CAMERA AND AIRSEAL PORT. THEY ALSO EXTENDED THE PORT INCISION AND INSPECTED THE ABDOMINAL WALL. THEY WERE UNABLE TO LOCATE THE MISSING FRAGMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT UNDERWENT ROBOTIC PROSTATECTOMY WITH S1. AFTER ROBOT DOCKED, SURGEON NOTED HAD CONTROLS WERE NOT COINCIDING WITH THE INSTRUMENTS INSIDE THE PT. CALLED TO INTUITIVE TECHNICAL SUPPORT LINE WITH REAL TIME TROUBLE SHOOTING FOR 45 MINUTES. TECH REP UNABLE TO RESOLVE ISSUE. THE ROBOTIC PROSTATECTOMY WAS ABORTED, THE PROCEDURE CONVERTED TO AN OPEN PROSTATECTOMY FOR PT SAFETY. F/U INVESTIGATION FOUND A WIRE FROM AN ELECTRICAL BOARD ON THE CAMERA ARM AT THE UPPER JOINT HAD ACTUALLY BEEN CAUGHT IN THE JOINT. WHEN THE ARM WAS MOVED SIDE TO SIDE IT WOULD CAUSE TENSION EFFECT ON THE WIRE. THE WIRE HAD COMPLETELY SEVERED. THIS DID NOT SHOW UP ON THE IT DATA REPORT BUT WAS DISCOVERED UPON VISUAL EXAM OF THE ROBOTIC ARM.

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 2 WEEKS POST A SUCCESSFUL DA VINCI ASSISTED SINGLE-VESSEL SMALL THORACOTOMY PROCEDURE; THE PATIENT HAD DIMINISHED BRAIN FUNCTION. CURRENTLY THE PATIENT IS IN A COMA. ON 11/16/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO ASSISTED DURING THE PROCEDURE; HE STATED THAT APPROXIMATELY TWO WEEKS POST-OPERATIVELY, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM WITH DIMINISHED BRAIN FUNCTION. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AFTER THE INTERNAL MAMMARY ARTERY THAT HAD BEEN HARVESTED ROBOTICALLY DURING THE PROCEDURE TWO WEEKS PREVIOUSLY WAS FOUND TO BE BLEEDING. THE SURGEON STATED HE COULD NOT CONFIRM ANY ROOT CAUSE FOR THE BLEEDING; HOWEVER, HE STATED THAT SINCE IT HAPPENED TWO WEEKS AFTER THE PROCEDURE HE BELIEVES THE COAGULUM COULD HAVE SLOUGHED OFF. AS PER THE HOSPITAL'S FOLLOW THE HEART PROGRAM, THE PATIENT WAS MONITORED AND WAS DOING WELL UNTIL THIS ACUTE EVENT HAPPENED. THE IMA HARVESTING WAS DONE ROBOTICALLY AND THE REST OF THE PROCEDURE WAS DONE AS A TRADITIONAL OPEN PROCEDURE. ON FURTHER FOLLOW UP WITH THE ISI CLINICAL SALES MANAGER IT WAS STATED THAT WHEN THE PATIENT CAME IN WITH A DIMINISHED BRAIN FUNCTION THE B

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE, DURING THE PATIENT'S POST-OPERATIVE RECOVERY, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE AND THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE SURGEON'S INTERPRETATION OF THIS FEATURE WAS THAT COMPLETION OF THE AUTO STOP TONE WAS AN INDICATION THAT A VESSEL WAS ADEQUATELY SEALED. ACCORDING TO THE CSR, AFTER COMPLETION OF THE AUTO STOP TONE, THE SURGE

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 SUCCESSFUL DA VINCI ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE; HOWEVER THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE. THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE DATE OF THE REPORTED EVENT WAS NOT PROVIDED BY THE HOSPITAL AND THERE IS NO VIDEO RECORDING OF THE PLANNED SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI ASSISTED CHOLECYSTECTOMY PROCEDURE ON AN UNSPECIFIED DATE, DURING THE PATIENT'S POST-OPERATIVE RECOVERY, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO DETERMINE THE SOURCE OF THE BLEEDING; HOWEVER, THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE. THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE SURGEON'S INTERPRETATION OF THIS FEATURE WAS THAT COMPLETION OF THE AUTO STOP TONE WAS AN INDICATION THA

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 CHOLECYSTECTOMY PROCEDURE, THE SURGEON GOT INTO BLEEDING AND THE CASE WAS CONVERTED TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT LOST 2700 CC OF BLOOD AND WAS ALSO GIVEN 4 UNITS OF BLOOD. IT WAS ALSO REPORTED THAT THE SURGEON TRANSECTED AND CLIPPED THE COMMON DUCT DURING THE SURGICAL PROCEDURE. 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 IN THE OR ON THE DAY OF THE SURGERY BUT HAD ALREADY LEFT WHEN THE REPORTED EVENT OCCURRED. AT THE BEGINNING OF THE SURGERY, THE CSR NOTED THE PATIENT'S GALLBLADDER AS BEING THICK AND ABNORMAL. HE ALSO STATED THAT THE PATIENT'S CYSTIC DUCT WAS VERY SHORT. FIREFLY WAS USED DURING THE SURGICAL PROCEDURE. AFTER THE REPORTED EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON AND THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE CSR, THE SURGEON THOUGHT HE HAD CLIPPED AND TRANSECTED THE CYSTIC DUCT. HOWEVER, THE SURGEON HAD INADVERTENTLY CLIPPED AND TRANSECTED THE COMMON BILE DUCT INSTEAD. AFTER REPAIRING THE COMMON BILE DUCT, THE SURGEON PROCEEDED WITH THE S

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 A FEW DAYS AFTER COMPLETION OF A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, A SMALL HOLE THAT WAS DESCRIBED AS BEING PIN POINT IN SIZE WAS FOUND IN THE BOWEL. AS A RESULT THE PATIENT CAME BACK WITH UNSPECIFIED SIGNS OF INFECTION AND UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE IN THE BOWEL. ON 09/30/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED THAT HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND THAT THE PROCEDURE WAS NOT RECORDED. APPROXIMATELY A FEW DAYS AFTER THE PROCEDURE THE CSR BELIEVES THE PATIENT CAME BACK TO THE HOSPITAL WITH SIGNS OF INFECTION. TO HIS KNOWLEDGE, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE. THE CSR MENTIONED THAT OTHER LAPAROSCOPIC INSTRUMENTS WERE USED DURING THE INITIAL CHOLECYSTECTOMY SURGICAL PROCEDURE. WHEN THE CSR FOLLOWED UP WITH THE SURGEON, THE SURGEON STATED ROBOTICALLY THE SURGERY WENT VERY WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE CSR, TH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5066629 WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2016 MY SON, (B)(6) HAD HIS GALL BLADDER REMOVED AT (B)(6) HOSPITAL BY ROBOTIC SURGERY. TWO DAYS LATER I TOOK HIM TO THE ER WHERE IT WAS DISCOVERED THAT HIS SMALL INTESTINES HAD BEEN PUNCTURED DURING SURGERY. ULTIMATELY, HE HAD TO HAVE SMALL BOWEL RESECTION, HE HAD PERITONITIS, ETC. LIST ALL CURRENT PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USE: NONE, JUST FINISHED A 2-PACK, AS HE WAS JUST DIAGNOSED WITH PNEUMONIA. LIST ALL OVER-THE-COUNTER MEDICATIONS: NONE (ADVIL FOR PAIN) OCCASIONALLY, WHEN HE CANNOT STAND IT. ON (B)(6) 2017, ISI CONTACTED THE INITIAL REPORTER. HOWEVER, THE INITIAL REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE FOLLOWING INFORMATION IS UNKNOWN AT THIS TIME: HOSPITAL NAME WHERE THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED AND THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 03/01/2017 FOR MW5066629: I SUBMITTED A MEDICAL DEVICE REPORT AFTER MY SON WAS INJURED FOLLOWING SURGERY WITH A DA VINCI ROBOTIC SYSTEM. (MW5066629) AFTER I SUBMITTED MY REPORT TO YOUR AGENCY, I RECEIVED A CALL FROM SOMEONE IN THE REGULATORY COMPLAINTS DEPARTMENT AT INTUITIVE SURGICAL (MAKERS OF THE DA VINCI ROBOTIC SYSTEM). HE SAID HE HAD RECEIVED A COPY OF MY SON'S INJURY REPORT FROM THE FDA AND HE WANTED TO KNOW THE NAME OF THE SURGEON AND THE HOSPITAL WHERE THE INJURY HAPPENED. HE HAD THE DATE OF THE SURGERY, KNEW FROM MY AREA CODE THAT I WAS FROM THE (B)(6) AREA AND SAID HE DID HAVE ONE REPORT OF AN INJURY BEING REPORTED IN (B)(6) ON OR AROUND THAT DATE. ((B)(6) 2016 WAS THE DATE OF THE INITIAL SURGERY, (B)(6) 2016 WAS THE DATE OF THE EMERGENCY SURGERY AFTER THE INJURY WAS DISCOVERED). I RESPONDED, "OH GOOD, SO THE SURGEON OR THE HOSPITAL DID REPORT THE INJURY PROCEEDING THE DA VINCI SURGERY TO YOUR COMPANY." THE MAN IN THE REGULATORY DEPARTMENT THEN SAID, "WELL NOT EXACTLY, THE SURGEON REPORTED THE INJURY TO OUR DA VINCI SALES PERSON, AND I FILED MY REPORT TO THE FDA BASED UPON WHAT OUR SALES PERSON REPORTED TO ME." (I FOUND IT

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 HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S URETER WAS CUT. THE PATIENT UNDERWENT 2 SUBSEQUENT SURGICAL PROCEDURES AND IS GOING TO UNDERGO A 3RD PROCEDURE TO REPAIR THE DAMAGE TO HER URETER. IT WAS ALSO REPORTED THAT THE PATIENT HAS A BAG. ON (B)(6) 2016 INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION FROM THE PATIENT REGARDING THE REPORTED EVENT. ACCORDING TO THE PATIENT, SHE UNDERWENT THE PLANNED SURGICAL PROCEDURE ON (B)(6) 2016 AND WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON POST-OP DAY 3 SHE PRESENTED TO THE HOSPITAL'S EMERGENCY ROOM DEPARTMENT AND IT WAS DISCOVERED THAT HER URETER WAS CUT. ACCORDING TO THE PATIENT, THE DAMAGE TO HER URETER PREVENTED HER KIDNEY FROM DRAINING. IN ADDITION TO UNDERGOING TWO SUBSEQUENT LAPAROSCOPIC PROCEDURES TO RESOLVE THE DRAINAGE ISSUE SHE CURRENTLY HAS A TEMPORARY UROSTOMY BAG. SHE IS EXPECTED TO UNDERGO THE 3RD SURGICAL PROCEDURE TO REPAIR HER URETER IN APPROXIMATELY 1 MONTH. ACCORDING TO THE PATIENT, THERE WAS NO REPORT TO HER BY THE HOSPITAL THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM AND/OR INSTRUMENTS OCCURRED DURING THE SURGICAL PROCEDURE. TH

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 — 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 APRIL 1, 2016 - JULY 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2012 - (B)(6) 2014.