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 PROSTATECTOMY SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL INTO THE PATIENT'S ANATOMY AND WAS NOT RETRIEVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 10-AUG-AND 19-AUG-2020 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE IS UNKNOWN. THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY WITH THE INSTALLATION TOOL. THERE WAS NO RESISTANCE FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE MCS INSTRUMENT AND NO INSTRUMENT COLLISIONS. THE MCS INSTRUMENT WAS IN USE DURING THE WHOLE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT AT THE END OF THE PROCEDURE AND IT COULD NOT BE FOUND. IT WAS NOT RETRIEVED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. IT WAS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. THE PATIENT¿S STATUS WAS "NORMAL." THE PROCEDURE WAS NOT RECORDED ON VIDEO.

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 PROSTATECTOMY SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL INTO THE PATIENT'S ANATOMY AND WAS NOT RETRIEVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 10-AUG-2020 AND 19-AUG-2020 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE IS UNKNOWN. THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY WITH THE INSTALLATION TOOL. THERE WAS NO RESISTANCE FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE MCS INSTRUMENT AND NO INSTRUMENT COLLISIONS. THE MCS INSTRUMENT WAS IN USE DURING THE WHOLE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT AT THE END OF THE PROCEDURE AND IT COULD NOT BE FOUND OR RETRIEVED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. IT WAS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. THE PATIENT¿S STATUS WAS "NORMAL." THE PROCEDURE WAS NOT RECORDED ON VIDEO.

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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF A HARMONIC ACE INSTRUMENT BROKE WHEN IN A PATIENT; IT¿S THE 3RD TIME IT HAPPENED WITHIN THE MONTH. THERE WAS NO REPORT OF PATIENT INJURY. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON: DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, THE TIP OF A HARMONIC ACE INSTRUMENT FELL OFF INTO THE PATIENT WHILE THE SURGEON WAS OPENING A VAGINAL CUFF. THE BROKEN SINGLE PIECE WAS FOUND AND VISUALLY REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT; NO X-RAY WAS NEEDED AS THE FRAGMENT WAS SEEN AND RETRIEVED VISUALLY. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND NO MEDICAL INTERVENTION, OTHER THAN FRAGMENT RETRIEVAL, WAS REQUIRED. THE INSTRUMENT DID TOUCH THE PLASTIC OF THE V-CARE MANIPULATOR. THE INSTRUMENT WAS NEVER REMOVED AND IT WAS IN USE INTERMITTENTLY FOR APPROXIMATELY 15 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS NOT REMOVED AT ANY TIME PRIOR TO THE EVENT. THERE WERE NO POST-OPERATIVE COMPLICATIONS AND THE PATIENT IS RECOVERING APPROPRIATELY. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO REPORTED 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: ON 19-MAY-2022, INTUITIVE SURGICAL, INC (ISI) RECEIVED FDA VOLUNTARY REPORT #MW5109945 WITH THE FOLLOWING EVENT DESCRIPTION: "BOWEL AND URETER PERFORATION; DA VINCI ASSIST HYSTERECTOMY PERFORMED AND NO PROBLEMS UNTIL 5 DAYS POST-OP. CT SCAN REVEALED PERITONITIS AND OPEN LAPAROTOMY BOWEL RESECTION WAS PERFORMED 7 DAYS POST-OP (REVEALED INJURY TO SMALL BOWEL) AND ADDITIONAL CT REVEALED THAT R URETER WAS ALSO SEVERED (STENT PLACED 9 DAYS POST-OP). URETERAL-VAGINAL FISTULA AND SEVERE UROSEPSIS IN (B)(6) 2020. I UNDERWENT 7 MORE SURGICAL PROCEDURES AND HAVE HAD 14 CT SCANS OF THE ABDOMEN IN 18 MONTHS FOLLOWING THE INJURY. STAGED URETERAL REIMPLANTATION WAS PERFORMED 6 MONTHS POST-OP AND ADDITIONAL TREATMENTS FOR SEVERE ABDOMINAL PAIN AND RIGHT AND LEFT KIDNEY HYDRONEPHROSIS, ADHESIONS, HERNIA AND INCONTINENCE REMAIN. SURGEONS SUSPECT THERMAL INJURY AS URETERS WERE SCOPED IN THE INITIAL PROCEDURE. NOT SURE ABOUT MODEL (SI, SP, X) BUT MONOPOLAR SCISSORS WERE USED AS WELL AS PK APPARATUS. REPEATED ATTEMPTS TO GET INFO FROM THE HOSPITAL AND INTUITIVE (MANUFACTURER) HAVE FAILED. OTHER THAN MY SURGEON'S OP REPORT, I HAVE NOT BEEN GIVEN THE INFORMATION I NEED TO RESEARCH THIS EQUIPMENT IN DETA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BOWEL AND URETER PERFORATION; DA VINCI ASSIST HYSTERECTOMY PERFORMED AND NO PROBLEMS UNTIL 5 DAYS POST-OP. CT SCAN REVEALED PERITONITIS AND OPEN LAPAROTOMY BOWEL RESECTION WAS PERFORMED 7 DAYS POST-OP (REVEALED INJURY TO SMALL BOWEL) AND ADDITIONAL CT REVEALED THAT R URETER WAS ALSO SEVERED (STENT PLACED 9 DAYS POST-OP). URETERAL-VAGINAL FISTULA AND SEVERE UROSEPSIS IN (B)(6) 2020. I UNDERWENT 7 MORE SURGICAL PROCEDURES AND HAVE HAD 14 CT SCANS OF THE ABDOMEN IN 18 MONTHS FOLLOWING THE INJURY. STAGED URETERAL REIMPLANTATION WAS PERFORMED 6 MONTHS POST-OP AND ADDITIONAL TREATMENTS FOR SEVERE ABDOMINAL PAIN AND RIGHT AND LEFT KIDNEY HYDRONEPHROSIS, ADHESIONS, HERNIA AND INCONTINENCE REMAIN. SURGEONS SUSPECT THERMAL INJURY AS URETERS WERE SCOPED IN THE INITIAL PROCEDURE. NOT SURE ABOUT MODEL (SI, SP, X) BUT MONOPOLAR SCISSORS WERE USED AS WELL AS PK APPARATUS. REPEATED ATTEMPTS TO GET INFO FROM THE HOSPITAL AND INTUITIVE (MANUFACTURER) HAVE FAILED. OTHER THAN MY SURGEON'S OP REPORT, I HAVE NOT BEEN GIVEN THE INFORMATION I NEED TO RESEARCH THIS EQUIPMENT IN DETAIL. ADHESIONS WERE EXTENSIVE, AND FOLEY CATHETER AS WELL AS URETERAL STENT WAS PLACED FOR POST-OP PERIOD. FDA SAFETY REPORT ID

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 THERE WAS EXCESSIVE MOBILITY OF THE TIP COVER CAUSING IT TO FALL INTO THE SURGICAL SITE. THE TIP COVER WAS RETRIEVED AND THERE WAS NO CONSEQUENCES TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) PERFORMED MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THIS EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO MORE DETAILS HAVE BEEN 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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, A BURN INJURY WAS IDENTIFIED ON THE SMALL INTESTINE. THE INTRA-OPERATIVE COMPLICATION WAS FOUND WHILE THE SURGEON WAS CHECKING FOR BLEEDING TOWARDS THE END OF THE PROCEDURE. AFTER THE BURN INJURY WAS IDENTIFIED, THE SURGICAL STAFF INSPECTED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT AND IDENTIFIED A HOLE. THE SITE BELIEVES THE BURN INJURY WAS RELATED TO THE HOLE FOUND ON THE MCS TIP COVER ACCESSORY. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP INSTRUMENT/ACCESSORY. ON 28-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON AND A NURSE: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REPORTEDLY REVIEWED A VIDEO OF THE PROCEDURE WITH THE SURGEON. PER THE CSR, A COLLISION WAS OBSERVED INTRA-OPERATIVELY BETWEEN THE MCS INSTRUMENT AND A TIP-UP FENESTRATED GRASPER INSTRUMENT INSTALLED ON ARM #4. THE MCS TIP COVER ACCESSORY WAS REPORTEDLY HIT AND A HOLE WAS IDENTIFIED IN THE GREY AREA OF THE TIP COVER. DURING THE COURSE OF THE PROCEDURE, ARCING OF ELECTRI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT HAD A VERY LARGE UTERUS WHICH MADE THE CASE VERY DIFFICULT. THE MCS INSTRUMENT WAS DIFFICULT TO REMOVE; THE CUSTOMER FELT TENSION AND IT WAS NOTED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. THE CUSTOMER PERFORMED AN X-RAY PRIOR TO CLOSING THE PATIENT AND THE MCS TIP COVER ACCESSORY WAS NOT IDENTIFIED. A CT SCAN WITHOUT CONTRAST WAS ALSO PERFORMED POST-PROCEDURE. THE MCS TIP COVER ACCESSORY WAS STILL MISSING AND IT WAS NOT CONFIRMED IF IT WAS INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE 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: ON 12-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW 5096343 STATING: "SCISSOR TIP SHEATH ON INTUITIVE SCISSORS COMES OFF DURING SURGICAL PROCEDURE. FDA SAFETY REPORT ID#: (B)(4)." ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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 WITH HYSTERECTOMY PROCEDURE, THE SYSTEM LOST POWER MID- PROCEDURE. THE SYSTEM HAD AN UNSPECIFIED NON-RECOVERABLE FAULT AND THE ARMS WERE RED. THE SURGEON ELECTED NOT TO POWER CYCLE OR ATTEMPT TO RECOVER AND INSTEAD, DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPY DUE TO THE FACILITY POWER LOSS. THE SURGEON MENTIONED THAT THERE WAS A POSSIBLE PATIENT INJURY; HOWEVER, NO DETAILS WERE PROVIDED REGARDING THE POTENTIAL INJURY. THE INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER ABOUT THE POWER LOSS AND WAS INFORMED THAT A LIGHTNING STRIKE CAUSED THE POWER OUTAGE TO THE ENTIRE OPERATING ROOM (OR). WHEN THE POWER OUTAGE OCCURRED, THE PATIENT SIDE CART (PSC) REVERTED TO BATTERY BACKUP AS DESIGNED. WHEN THE POWER WAS RESTORED, THE SYSTEM BOOTED BACK UP BECAUSE OF THE PSC STILL BEING ON AND THE SYSTEM GENERATED A NON-RECOVERABLE ERROR DUE TO THE LOSS OF COMMUNICATION TO THE VISION SIDE CART (VSC). THE CUSTOMER POWER CYCLED ALL SUBSYSTEMS, AND BROUGHT THEM UP TOGETHER, AND THE SYSTEM WORKED PROPERLY. PER THE FSE, THE SYSTEM WAS WORKING AS INTENDED AND NO ADDITIONAL ACTION WAS RE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PANCREATICODUODENECTOMY PROCEDURE, A PSEUDOANEURYSM ALLEGEDLY OCCURRED DUE TO A POST-OPERATIVE PANCREATIC LEAK. IT WAS NOTED THAT A BRANCHED BLOOD VESSEL FROM THE SUPERIOR MESENTERIC ARTERY (SMA) HAD ¿BEEN LEFT CUT OFF BY THE SYNCHROSEAL¿ INSTRUMENT AFTER SEALING AND A PANCREATIC LEAK OCCURRED IN THE SURROUNDING AREA. FURTHERMORE, THE TISSUE TREATED WITH THE SYNCHROSEAL INSTRUMENT WAS BURNED AND APPEARED WHITE. IT WAS SUSPECTED THAT IT WAS DUE TO DAMAGE TO ¿J1V¿ (FIRST JEJUNAL VEIN). THE SURGEON COMMENTED THAT HE/SHE SHOULD HAVE USED THE SYNCHROSEAL INSTRUMENT WITH CAUTION. ON 27-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE SITE CANNOT PROVIDE THE VIDEO TO ISI FOR REVIEW. IT WAS EXPLAINED THAT AFTER A BRANCHED VESSEL FROM THE SMA WAS SEALED COMPLETELY WITH THE SYNCHROSEAL INSTRUMENT, THE SURGEON THEN CUT THE VESSEL. ALTHOUGH IT WAS NOTED THAT THE SITE BELIEVES NO MALFUNCTION OF THE SYNCHROSEAL INSTRUMENT OCCURRED, THE SITE CLAIMS THAT THE SYNCHROSEAL INSTRUMENT HAS A LARGE 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) 2020, INTUITIVE BECAME AWARE OF A ¿JOURNAL OF GASTROINTESTINAL ONCOLOGY¿ ARTICLE TITLED, ¿RARE POSTOPERATIVE HEMORRHAGE AFTER ROBOTIC-ASSISTED PANCREATODUODENECTOMY FOR PANCREATIC HEAD CANCER: A CASE REPORT¿ (ZHOU, J.J., CHEN, W., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. ON POST OPERATIVE DAY 6 PATIENT UNDERWENT AN EMERGENCY OPERATION DUE TO BLOOD IN VOMIT. PATIENT WAS FOUND TO HAVE AN OUTPUT JEJUNAL LOOP INTUSSUSCEPTION IN THE STOMACH. PATIENT WAS DISCHARGED ON POST OPERATIVE DAY 10 AND WAS REPORTED TO BE DOING WELL. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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 — 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 — 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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 21-JUL- 2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A SURGICAL ENDOSCOPY ARTICLE TITLED, ¿ROBOTIC TREATMENT FOR URINARY TRACT ENDOMETRIOSIS: PRELIMINARY RESULTS AND SURGICAL DETAILS IN A HIGH-VOLUME SINGLE-INSTITUTIONAL COHORT STUDY¿ (DIMAIDA, F., MARI,. A., MORESELLI, S., ET AL., 2020). THE AIM OF THE STUDY WAS TO PRESENT THE SURGICAL TECHNIQUES AND THE POSTOPERATIVE OUTCOMES IN WOMEN TREATED WITH ROBOTIC EXCISION FOR DEEP ENDOMETRIOSIS INVOLVING THE URINARY TRACT. THIS STUDY RETROSPECTIVELY REVIEWED THE PROSPECTIVELY RECORDED CLINICAL DATA OF WOMEN CONSECUTIVELY UNDERGOING MINIMALLY INVASIVE TREATMENT FOR COMPLEX ENDOMETRIOSIS INVOLVING URINARY TRACT IN OUR CENTER BETWEEN JANUARY 2012 AND JUNE 2018. A TOTAL OF 74 CONSECUTIVE PATIENTS WERE ENROLLED AND, OF WHICH, 46 WERE TREATED WITH ROBOTIC SURGERY WITH EITHER A DA VINCI SI OR XI DA VINCI SURGICAL SYSTEM. ALL THE PATIENTS RECEIVED A PREOPERATIVE MULTIDISCIPLINARY EVALUATION WITH THE GENERAL SURGEON, THE GYNECOLOGIST, AND THE UROLOGIST DUE TO THE FREQUENT CONCOMITANT INVOLVEMENT OF BOWEL AND GENITAL SYSTEM. PATIENTS UNDERGOING ROBOTIC SURGERY WERE TREATED WITH THE SI OR XI DA VINCI SURGICAL SYSTEM. WITHIN THE JOURNAL A

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 SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE CURVED SHEARS BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT OF THE SAME KIND WAS INSTALLED TO PROCEED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ALL FRAGMENTS WERE RETRIEVED DURING THE SAME SURGICAL PROCEDURE. REPORTEDLY, THE TIP WAS NEATLY BROKEN AND IMMEDIATELY REMOVED FROM THE PATIENT'S BODY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGEON WAS DISSECTING TISSUE WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE BREAKAGE. UPON THE FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE C

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

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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC CLIP APPLIER NOT HOLDING CLIPS. 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: IN REGARD TO THE ARTICLE ¿EARLY FEASIBILITY SURVEILLANCE OF GYNECOLOGIC ROBOTIC-ASSISTED SURGERIES IN JAPAN¿ WRITTEN BY TSUKASA BABA, MASAKI MANDAI, HIROTAKA NISHI, OSAMU NISHII, JO KITAWAKI, MORIO SAWADA, KEIICHI ISAKA AND TOMOYUKI FUJII, AND PUBLISHED IN THE JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH, DR. TSUKASA BABA INDICATED THAT HE HEARD OF A COLLISION INDUCED RECTAL INJURY THAT OCCURRED ¿OUTSIDE OF VIEW.¿ DR. BABA INDICATED THAT HE WAS ¿NOT SURE [IF] THE PATIENT SUFFERED FROM SEPTIC SHOCK OR UNDERWENT ANASTOMOSE OR OTHER INTENSIVE CARE.¿ INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT, BUT AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN 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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, THE SURGEON HAD GRASPED UNSPECIFIED TISSUE WITH A HARMONIC ACE INSTRUMENT AND WAS NOT AWARE THAT THE INSTRUMENT HAD A BROKEN METAL PIECE. IT WAS ALSO NOTED THAT THERE WAS "EXCESSIVE BLEEDING" AND THE SURGICAL STAFF HAD DIFFICULTY CONTROLLING THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, THE SURGEON BELIEVES THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, NO MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE BLEEDING AND THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. PER THE INITIAL REPORTER, THE PATIENT'S CURRENT STATUS WAS "RECOVERED." ON 10-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. THE CUSTOMER COULD NOT RECALL WHAT SPECIFIC TISSUE WAS INVOLVED WITH THE "EXCESSIVE BLEEDING." AFTER A TISSUE INCISION WAS MADE USING THE HARMONIC ACE INSTRUMENT, THE SURGEON ATTEMPTED TO USE THE COAGULATION FUNCTION. AT THAT TIME, THE CUSTOMER CLAIMED THAT THE INSTRUMENT DID NOT WORK AND BLEEDING OCCURRED. THE SURGEON WAS ABLE TO ACHIEVE HEMOSTASIS BY U

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 — 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 — 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 — 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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SPLIT WAS EXTENDING INTO THE DARKER GRAY PLASTIC ON THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE DA VINCI COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE IN USE APPROXIMATELY FOUR HOURS INTERMITTENTLY, AND THEN A TEAR ON THE WAS NOTED ON THE MCS TIP COVER ACCESSORY. WHILE THE MCS INSTRUMENT WAS BEING REMOVED FROM THE PATIENT, THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT HAVING POSSIBLY GOTTEN CAUGHT ON THE CANNULA. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT. THERE WAS NO MCS INSTRUMENT FUNCTIONALITY ISSUE NOTED. IT IS UNKNOWN IF THE MCS INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS, IF THE SURGICAL STAFF FELT ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, OR IF THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE MCS

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 THYROIDECTOMY SURGICAL PROCEDURE, THE SURGEON WAS USING THE HARMONIC ACE BLADE TO DISSOCIATE THE TISSUE WHEN THE CURVED BLADE SEPARATED FROM THE INSTRUMENT INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND THE INSTRUMENT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, OR INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BARIATRIC REVISION SURGICAL PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA NEAR THE AREA OF DISSECTION WITH A SYNCHROSEAL INSTRUMENT. INITIAL INFORMATION RECEIVED FROM THE REPORTER INDICATED THAT HE BELIEVED THIS WAS CAUSED BY THE SYNCHRO SEAL INSTRUMENT THAT WAS USED DURING A BARIATRIC ROBOTIC PROCEDURE. THE PATIENT REPORTEDLY HAD A SECOND (UNSPECIFIED) PROCEDURE TO ADDRESS THE HEMATOMA. IT WAS NOTED THAT THE INSTRUMENT WAS DISCARDED AS NO ISSUE WAS SUSPECTED FOLLOWING INITIAL PROCEDURE COMPLETION. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT AFTER UNDERGOING A SLEEVE GASTRECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED WITH NO ISSUE REPORTED. HOWEVER, POST-OPERATIVELY THE PATIENT HAD NOT BEEN ¿FEELING WELL¿ AND CALLED THE SURGEON TO REPORT IT. THE SURGEON RECOMMENDED THAT THE PATIENT COME INTO THE HOSPITAL. HOWEVER, THE PATIENT DECIDED TO GO TO ANOTHER HOSPITAL TO SEEK TREATMENT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A DIAGNOSTIC TEST CONDUCTED, WHICH INDICATED A POSSIBLE HEMATOMA. IT IS BELIEVED THAT THE PATIENT UNDE

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 — 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 — 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 — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY LOOSENED DURING USE. IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED 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 THYROIDECTOMY SURGICAL PROCEDURE, THE SURGEON WAS USING THE HARMONIC ACE BLADE TO DISSOCIATE THE TISSUE WHEN THE CURVED BLADE SEPARATED FROM THE INSTRUMENT WHILE INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND THE INSTRUMENT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, OR INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED PRODUCT WAS INSPECTED PRIOR TO USE. ALL FRAGMENT(S) WERE RETRIEVED. THE ASSISTANT USED THE DA VINCI ENDOSCOPE TO SEARCH FOR THE FRAGMENT AND USED THE LAPAROSCOPIC INSTRUMENT TO GRASP THE FRAGMENT AND PULL IT OUT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. NO ISSUES WERE OBSERVED WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON DID NOT EXPERIENCE ANY ISSUES WITH REMOVING THE INSTRUMENT PRIOR TO THE BREAKAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPE

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 DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE SYNCHROSEAL INSTRUMENT ARCED AT THE JAWS. THE SURGEON BELIEVED THAT IT WAS TRIGGERED BY A THICK, ROUND, LIGAMENT OF TISSUE. THE GENERATOR DID NOT SHUT OFF DUE TO THE REPORTED ARCING INCIDENT, BUT DAMAGE WAS NOTED BETWEEN THE JAWS OF THE INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY WITH NO REPORTED INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON, REGARDING THE REPORTED EVENT: THE SURGEON CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT WAS INSPECTED AT THE BEGINNING OF THE CASE AND NO DAMAGE WAS NOTED. THE ARCING EVENT WAS NOTED AFTER ABOUT FIVE MINUTES OF USE. THE SURGEON BELIEVED THAT THE ARCING EVENT OCCURRED DUE TO THE JAWS NOT CLOSING COMPLETELY ON A THICKER PORTION OF TISSUE. THE SURGEON CONFIRMED THAT THE INSTRUMENT WAS NOT REMOVED ANY TIME PRIOR TO THE ARCING EVENT. UPON REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. THE SURGEON CONFIRMED THAT THERE WAS NO PATIENT HARM, INJURY OR ADVERSE OUTCOME DUE TO THE REPORTED ARCING INCIDENT. 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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 — 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.