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 SURGICAL PROCEDURE, A RUBBER PIECE FROM A CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT¿S ANATOMY DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE FRAGMENT WAS RETRIEVED BY A GRASPER. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED FROM THE PATIENT DURING THE PROCEDURE USING A GRASPER INSTRUMENT. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THERE WAS NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS. THE CANNULA SEAL WILL NOT BE RETURNED. THE PROCEDURE WAS DELAYED ABOUT FIVE MINUTES.

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 CUSTOMER OBSERVED THAT THE SYNCHROSEAL INSTRUMENT HAD PARTS THAT WERE FALLING OFF FROM THE HINGES. IT WAS NOTED THAT FRAGMENTS FELL INSIDE THE PATIENT AND WERE RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WERE NO ABNORMALITIES FOUND. AT THE TIME OF THE REPORTED EVENT OF THE FRAGMENT FALLING INSIDE THE PATIENT, THE SURGICAL TASK THAT WAS BEING PERFORMED WAS DISSECTING AND GRASPING. THE FRAGMENT(S) WERE ABLE TO BE REMOVED BY USING "LAPALO FORCEPS" BY THE ASSISTANT DOCTOR, AND ALL FRAGMENTS WERE CONFIRMED TO HAVE BEEN REMOVED FROM THE BODY. POST-OPERATIVE X-RAYS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON COMMENTED THAT A SIMILAR PHENOMENON HAD OCCASIONALLY OCCURRED WITH A THIRD COMPANY'S PRODUCTS. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE SYNCHROSEAL. THERE WAS NO INSTRUMENT COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR 316. THE CUSTOMER DID NOT MANAGE TO CALL TECHNICAL SUPPORT AND AFTER SEVERAL TRIES, THE CUSTOMER DECIDED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC APPROACH BECAUSE THE SYSTEM ISSUE COULD NOT BE SOLVED IN 30 - 40 MINUTES AND THE SURGEON HAD A BUSY SCHEDULE AFTER, THE CUSTOMER COULD NOT WAIT MORE TIME. THE SURGERY WAS PERFORMED LAPAROSCOPICALLY. AN INCISION WAS MADE TO EXTRACT THE SPECIMEN AND TO PERFORM AN EXTRA CORPORAL ANASTOMOSIS (AS THE SURGEON USUALLY DOES IN LAPAROSCOPY). BUT IF THE SURGERY WERE PERFORMED ROBOTICALLY, THE SURGEON WOULD HAVE PROBABLY PERFORMED AN INTRACORPORAL ANASTOMOSIS, AND MAKE A SMALL INCISION TO EXTRACT THE SPECIMEN. THE ISSUE WAS NOT SOLVED WHEN THE SURGEON PLACED THE ROBOTIC CANNULAS IN THE PATIENT. THE EVENT OCCURRED AFTER INCISION AND PORT PLACEMENT. NO OTHER SURGICAL TASKS PERFORMED BEFORE THE SYSTEM ISSUE. THE CUSTOMER NOTED THAT THE OPERATION WAS PROLONGED FOR AROUND 30 MINUTES

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 RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY WAS NOT RECOGNIZED AND A "RELEASE THE PRESSURE" ERROR MESSAGE WAS DISPLAYED. AFTER REMOVING THE HARMONIC ACE INSTRUMENT, THE INSTRUMENT BLADE WAS FOUND TO BE BROKEN AND HAD FALLEN INSIDE THE PATIENT'S CAVITY. THE BROKEN OFF BLADE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE INSTRUMENT BLADE BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. ALL FRAGMENT(S) WERE CONFIRMED TO HAVE BEEN RETRIEVED VIA A VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. IT WAS UNKNOWN HOW LONG THE INSTRUMENT WAS USED PRIOR TO THE ISSUE BUT THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING USE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED,

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 MOUTH OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE OF THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ABOUT THE EVENT. THE SURGEON AND ASSISTANT REMOVED THE INSTRUMENT FRAGMENT WITH THE USE OF AN ENDOSCOPE. THERE WERE NO ADDITIONAL PROCEDURES OR POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THE ISSUE WAS DUE TO AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS DETECTED. THERE WAS NO PATIENT INJURY.

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 WHEN THE SURGEON MOVED THE MONOPOLAR CURVED SCISSORS (MCS), THE MCS TIP COVER ACCESSORY FELL OFF OF THE SCISSORS. THE MCS TIP COVER WAS RETRIEVED AND REMOVED FROM INSIDE THE PATIENT. A NEW MCS TIP COVER WAS PLACED ON THE MCS INSTRUMENT, AND NO OTHER PROBLEMS WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE, NO APPARENT DAMAGE WAS FOUND. THE BEDSIDE ASSISTANT USED A LAPAROSCOPIC GRASPER WHILE THE SURGEON USED HIS GRASPER TO HELP BRING IT WITHIN THE ASSISTANT'S REACH. DISSECTION WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. NO FUNCTIONALITY ISSUES WERE FOUND. THE MCS INSTRUMENT DID NOT HAVE ANY COLLISIONS. A REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY IN REMOVING THE MCS, OR THE TIP COVER. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. TINY HOLES WERE FOUND IN THE TIP COVER AFTER IT WAS REMOVED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 30-45 MINUTES. ANOTHER TIP COVER WAS PLACED ON THE SCISSORS INSTRUMENT

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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE SHEERS BROKE, AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT. THE CUSTOMER REMOVED THE SHEATH FROM THE PATIENT. THE MCS TIP COVER WAS THROWN OUT AND WILL NOT BE RETURNED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD 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: SURGEON AND OTHER STAFF WERE USING THE DAVINCI XI FOR A UROLOGICAL PROCEDURE. THE OUTFIELD AND INFIELD MONITORS IN THE OPERATING ROOM FLICKERED MULTIPLE TIMES THROUGHOUT CASE IN OPERATING ROOM AND EVENTUALLY WENT BLACK. REDUCED VISUALIZATION AND INABILITY TO SEE VISION TOWER RESULTED IN SMALL NICK TO BLADDER NECK. PHYSICIAN ABLE TO REPAIR TEAR. THIS ISSUE OF MONITORS FLICKERING AND GOING BLACK HAS HAPPENED MANY TIMES BEFORE, BUT WITHOUT INJURY TO A PATIENT. MANUFACTURER RESPONSE FOR DAVINCI XI MONITORS, DAVINCI XI (PER SITE REPORTER). MANUFACTURER WILL ARRIVE NEXT WEEK TO TROUBLESHOOT THE DEVICE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE THAT TIP-UP FENESTRATED GRASPER INSTRUMENT HAD ENGAGEMENT ISSUES. THE PROCEDURE WAS COMPLETED AS AN OPEN PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: IT WAS REPORTED TO THE INITIAL REPORTER THAT THE INSTRUMENT DIDN'T WORK AND/OR BROKE DURING THE PROCEDURE AND THAT THE PROCEDURE WAS CHANGED TO AN OPEN PROCEDURE. REPORTEDLY, THE CONVERSION TO AN OPEN PROCEDURE DID NOT HAVE ANYTHING TO DO WITH THE INSTRUMENT BREAKING.

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 STAPLER STOPPED IN THE MIDDLE OF THE FIRING PROCESS AND DID NOT COMPLETE FIRING. STAPLER AND RELOAD WERE RETRIEVED FROM PATIENT AND PROCEDURE CONTINUED LAPAROSCOPICALLY INSTEAD OF WITH THE ROBOT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BLADE FRACTURED, AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BACKUP DA VINCI INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED USING THE ENDOSCOPE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED AND THERE WERE NO POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THE ISSUE WAS AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS BEING USED FOR DISSECTING FOR ABOUT 40 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES FOUND. THE SYSTEM SHOWED THAT THE SURGEON NEEDED TO REDUCE THE INSTRUMENT TIP PRESSURE. THERE WAS NO INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED PRIOR TO THE BREAKAGE DURING THE PROCEDURE WHEN CLEANING THE INSTRUMENT. UPON FINAL REMOVAL, THERE WAS NO RESISTANCE, NO DAMAGE TO THE CANNULA, AND NO ADDITIO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT UNDERWENT A SINGLE PORT DA VINCI-ASSISTED PARTIAL NEPHRECTOMY ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES MALFUNCTION OCCURRED DURING THE SURGERY. THERE WERE ALSO NO INTRA-OPERATIVE COMPLICATIONS REPORTED. ON (B)(6) 2023, THE PATIENT EXPERIENCED BILATERAL DEEP VEIN THROMBOSIS OF THE LEFT LOWER EXTREMITIES. A VASCULAR ULTRASOUND WAS PERFORMED AND CONFIRMED THE DIAGNOSIS. ENOXAPARIN 4000IU WAS GIVEN FOR THE THROMBOSIS. ON (B)(6) 2023, THE PATIENT WAS FOUND WITH A HEMATOMA IN THE LEFT RENAL AREA FROM A ULTRASOUND. NO MEDICAL INTERVENTION WAS PERFORMED FOR THE FINDING. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITHOUT REQUIRING PROLONGED HOSPITALIZATION. THE PATIENT HAD MEDICAL HISTORY OF URINARY SYSTEM DISEASE AND SIMPLE RENAL CYST AT LEFT KIDNEY. THE STUDY INVESTIGATOR THOUGHT THE BILATERAL DEEP VEIN THROMBOSIS WAS LIKELY CAUSED BY INTRAOPERATIVE PNEUMOPERITONEUM AND THE CAUSE OF THE RENAL HEMATOMA WAS DUE TO ANTICOAGULATIVE MEDICATION. IT WAS CONFIRMED THAT THERE WAS NO UNEXPECTED BLEEDING THAT COULD HAVE LED TO THE RENAL HEMATOMA.

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 A PATIENT WHO UNDERWENT A DA VINCI SINGLE PORT ASSISTED RADICAL PROSTATECTOMY FOR HIS PROSTATE CANCER AS PART OF A CLINICAL STUDY ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS NOR ANY MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES. ON (B)(6) 2023, AN ULTRASOUND SHOWED MULTIPLE CYSTIC FOCI IN BOTH KIDNEYS AND WAS SUSPECTED AS RENAL CYSTS, WHICH LIKELY CAUSED BY PATIENT'S MEDICAL CONDITIONS. A LYMPHATIC LEAK WAS ALSO SUSPECTED AND ASCITES ASPIRATION WAS PERFORMED ON (B)(6) 2023, DRAINAGE ON (B)(6) 2023 AS MEDICAL INTERVENTION. FURTHERMORE, A CT-GUIDED PUNCTURE AND PELVIC EFFUSION WAS PERFORMED ON (B)(6) 2023 AND THE SYMPTOMS WERE REPORTED AS RESOLVED ON (B)(6) 2023. THE PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO PERSONAL REASONS AND WAS DISCHARGED ON (B)(6) 2023.

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 HARMONIC ACE HEAD BROKE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE TIP BROKE INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND ALL FRAGMENTS WERE FOUND. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE NEEDED. NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON BELIEVES THE ISSUE IS DUE TO PRODUCT QUALITY. THE INSTRUMENT WAS USED FOR 10 MINUTES PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH INSTRUMENT FUNCTIONALITY PRIOR TO THE BREAK. THERE WAS NO INSTRUMENT COLLISION. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO ADDITIONAL DAMAGE TO THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL RELATED TO RETAINING A FOREIGN OBJECT.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PART OF THE SYNCHROSEAL INSTRUMENT CAME OUT. THE PART WAS RETRIEVED. A BACK UP INSTRUMENT WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A BENIGN HYSTERECTOMY. IT IS UNKNOWN HOW THE FRAGMENT FELL INTO THE PATIENT. THE EYELET WAS SPOTTED IN THE PATIENT, AND THEN THEY REALIZED WHAT IT WAS WHEN THEY SAW THE EYELET MISSING ON THE SYNCHROSEAL. NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NOT ANY POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE FRAGMENT WILL BE RETURNING WITH THE INSTRUMENT. IMAGES WERE PROVIDED. PARTIAL DEVICE INFORMATION PROVIDED WITH RETURN IMAGES.

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 HARMONIC ACE INSTRUMENT SUDDENLY STOPPED WORKING AND THE SYSTEM PROMPTED THE CUSTOMER TO CHANGE THE INSTRUMENT. THE CUSTOMER REMOVED THE FRACTURED PART OF THE INSTRUMENT COMPLETELY AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE 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: IN RESPONSE TO AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SURVEY ON XI / X MONOPOLAR INSTRUMENTS, A CUSTOMER RECALLED AN EVENT REGARDING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT WAS CONVERTED TO OPEN SURGERY DUE TO A MALFUNCTION AND / OR BREAKAGE OF AN UNSPECIFIED DA VINCI MONOPOLAR INSTRUMENT. THE CUSTOMER DID NOT SPECIFY THE NUMBER OF CONVERSIONS FROM DA VINCI SURGICAL PROCEDURE TO OPEN SURGERY FOR MALFUNCTION / BREAKAGE. THE CUSTOMER WHO RESPONDED TO THE SURVEY WAS ANONYMOUS. THE CUSTOMER DID NOT COMPLETE THE ENTIRE SURVEY LEADING TO INCOMPLETE 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 HARMONIC ACE INSTRUMENT SUDDENLY BROKE AND A PIECE FELL INSIDE THE PATIENT. THE FRACTURED PART WAS TAKEN OUT OF THE PATIENT DURING THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO CONTINUE WITH THE PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE SITE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. THE ISSUE OCCURRED ABOUT 1 HOUR AFTER THE PROCEDURE STARTED AND AS THE SURGEON WAS GRASPING TISSUE. THE SURGEON NOTICED UNSPECIFIED FUNCTIONALITY ISSUES WITH THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE OCCURRED. THE INSTRUMENT'S WRIST WAS STRAIGHTENED PRIOR TO REMOVAL AND THE OR STAFF DID NOT FEEL RESISTANCE WHILE REMOVING THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY THE ASSISTANT AND WERE REMOVED WITH ANOTHER FORCEPS. NO ADDITIONAL SURGICA

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 ADRENALECTOMY SURGICAL PROCEDURE, WHEN THE SYNCHROSEAL INSTRUMENT WAS BEING REMOVED, IT MADE SOME ABNORMAL MOVEMENTS AND A SMALL PIECE OF IT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON DOES NOT KNOW WHAT CAUSED THE FRAGMENT FAILING ISSUE. THE EXACT TIME OF HOW LONG THE INSTRUMENT WAS IN USE PRIOR TO THE ISSUE OCCURRING WAS UNKNOWN, BUT IT WAS DURING THE INITIAL WORK. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGEON SAW THE FRAGMENT FALL AS THE INSTRUMENT WAS BEING REMOVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO PATIENT INJURY. THE PATIENT HAD NOT RETURNED TO 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: 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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT A RECOVERABLE FAULT WAS REOCCURRING EACH TIME THE RECOVER FAULT WAS SELECTED. THE SYSTEM WAS NOT AVAILABLE ON ONSITE AND THE CUSTOMER EMAILED EVENT LOG IMAGE TO THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE). THE EVENT LOG IMAGE CONFIRMED ERROR 32100 AND INDICATED THAT THE ERROR WAS REPORTED BY SOAM-A AND POINTED TO THE EGM YAW BRAKE CURRENT IN THE YAW MOTOR ASSEMBLY. THE TSE RECOMMENDED TO PERFORM AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC), BUT THE ERROR PERSISTED. THE CUSTOMER STATED THAT THEY WERE GOING TO ATTEMPT TO CONVERT THE PROCEDURE TO MULTIPORT, USING THEIR XI SYSTEM. THE PROCEDURE WAS CONVERTED FROM A SINGLE-PORT SYSTEM TO AN XI DA VINCI SYSTEM. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE WAS BROKEN. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED WITH THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER CYSTECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT CLAMP CRACKED OPEN 8 MINUTES INTO THE PROCEDURE. THE BROKEN OFF INSTRUMENT FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT.

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 PLANNED DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AFTER DOCKING DUE TO THE LEFT EYE ON A 0-DEGREE ENDOSCOPE BEING BLURRY. THE CUSTOMER TRIED TO TROUBLESHOOT BY REPLACING THE ENDOSCOPE, BUT THE IMAGE WAS STILL BLURRED. THE TSE HAD THE CUSTOMER POWER CYCLE AND HARD CYCLE THE VISION SIDE CART (VSC) BUT THE IMAGE WAS STILL NOT COMING UP NORMALLY. THE TSE HAD THE CUSTOMER VERIFY THE IMAGE WAS BAD ON THE VSC AS WELL AS ON THE SURGEON SIDE CART (SSC). THE SURGEON OPTED TO CANCEL THE CASE. THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS FINE. THERE WERE NO COMPLICATIONS OR PATIENT INJURY POST-ANESTHESIA. THEY JUST HAD TO WAKE UP THE PATIENT AS THERE WAS NO SCOPE TO USE.

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 DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, 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 REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS DAMAGED AND THE COVER WAS TORN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE INSTRUMENT WAS COLLIDED WITH THE MONOPOLAR CURVED SCISSORS INSTRUMENT, AND THE PLASTIC WRIST COVER AND THE PLASTIC PART OF THE TIP WERE BROKEN AFTER THE COLLISION. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT¿S ANATOMY. POST-OPERATIVE TESTS (X-RAY AND ULTRASOUND) WERE PERFORMED. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS. THE PROCEDURE WAS DELAYED FOR TEN MINUTES. THE SYNCHROSEAL INSTRUMENT AND THE PLASTIC OVERMOLD WERE DISCARDED AND WILL NOT BE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

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 EXTENDED TOTALLY EXTRAPERITONEAL (ETEP) INCISIONAL HERNIA REPAIR PROCEDURE, THE PATIENT EXPERIENCED A CONVERSION TO OPEN AND A SUBSEQUENT SURGICAL PROCEDURE. THE ISSUE OCCURRED INITIALLY WHEN THE SYSTEM ENCOUNTERED A RECOVERABLE FAULT RELATED TO ARM 3. THE FAULT WITH ERROR CODE 23025 REPEATED ITSELF AS SOON AS RECOVERY WAS ATTEMPTED. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LIVE LOGS AND VERIFIED SEVERAL INSTANCES OF ERROR CODE 23025, INDICATING AXIS 1 ON RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED HAND CONTROL ASSIGNMENTS WITH ARM 3 BEING CONTROLLED BY THE LEFT MASTER TOOL MANIPULATOR (MTML) AND MTMR CONTROLLING ARM 1 TO RULE OUT ANY ARM ISSUES. THE FAULT RETURNED AND WAS STILL POINTING AT THE MTMR. THE SYSTEM WAS THEN POWER CYCLED, WHICH DID NOT RESOLVE THE ISSUE. THE MTMR WAS PUT THROUGH AN EXERCISING MOVEMENT AND A HARD POWER CYCLE WAS PERFORMED WITH THE EMERGENCY POWER OFF (EPO) OF THE SYSTEM, BUT THIS ALSO DID NOT RESOLVE THE ISSUE. THE SURGEON MADE THE CLINICAL DECISION TO OPEN DUE TO THE MTMR BEING INOPERABLE. THE PATIENT TOLERATED THE OPEN PROCEDURE. HOWEVER, POST-OPERATIVELY, THE PATIENT HAD A WOUND R

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 URETERAL REIMPLANTATION SURGICAL PROCEDURE THAT PATIENT SIDE MANIPULATOR (PSM) 3 WAS NOT ACCEPTING THE DRAPE. THE SITE TRIED RESEATING THE DRAPE MULTIPLE TIMES. A 30900 ERROR ALSO OCCURRED. THE SITE CHECKED TO ENSURE THAT THE DRAPE WAS EVEN, AND NO PART OF THE DRAPE WAS UNDERNEATH THE STERILE ADAPTOR. THE CUSTOMER RE-DRAPED THE SYSTEM, WITH NO CHANGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER EMERGENCY POWER OFF (EPO), AND POWER CYCLE THE SYSTEM, WITH NO CHANGE. THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE FROM THE SINGLE-PORT SYSTEM TO THEIR XI SYSTEM. THERE WERE NO REPORTS OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THERE WERE NO ERRORS OBSERVED BY THE CUSTOMER. THE DELAY WAS ROUGHLY ONE HOUR.

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 REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿LEARNING CURVE FOR SINGLE-PORT ROBOT-ASSISTED RECTAL CANCER SURGERY¿, THE FOLLOWING EVENTS WERE REPORTED. FROM APRIL 2019 TO OCTOBER 2019, 57 SINGLE-PORT ROBOTIC (SPR)-ASSISTED RECTAL CANCER SURGERIES PERFORMED BY ONE SURGEON WERE INCLUDED IN THE STUDY. A TOTAL OF 57 PATIENTS (34 MALES, 59.6%) WERE TREATED FOR RECTAL CANCER AND INCLUDED 34 LOW ANTERIOR RESECTION(LAR) (59.6%), 14 ULTRA-LAR (24.6%), 7 INTERSPHINCTERIC RESECTION (ISR) (12.3%), AND 2 APR (ABDOMINOPERINEAL RESECTION) (3.5%) CASES. AMONG THESE, 11 PATIENTS ADDITIONALLY UNDERWENT ROBOTIC TRANSANAL TOTAL MESORECTAL EXCISION (TATME). THE MEAN AGE OF THE PATIENTS WAS 57.4 ± 10.1 YEARS, THE MEAN BMI WAS 24.5 ± 3.5 KG/M2, AND THE MEDIAN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS (PS) CLASSIFICATION WAS II. THE MEAN VALUE OF TOTAL OPERATION TIME (OT) WAS 241.8 ± 91.7 MINUTES. THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS 158.4 ± 103.3ML. A TOTAL OF 23 COMPLICATIONS WERE IDENTIFIED IN THE PATIENTS WHO UNDERWENT SURGERY WHICH INCLUDES POSTOPERATIVE ILEUS, POSTOPERATIVE BLEEDING, CHYLOUS DRAIN COLOR CHANGE, AND URINARY RETENTIO

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: THE GEAR/CABLE MECHANISM OF THE FENESTRATED FORCE BIPOLAR BROKE WHILE GRASPING THE STOMACH. THE INSTRUMENT COULD NOT BE OPENED (WITH HELP OF INTUITIVE SUPPORT - WOULD NOT OPEN W/IRK) SO THE STOMACH WAS FORCIBLY REMOVED WHICH CAUSED A LARGE HOLE IN THE STOMACH. STOMACH REPAIRED IN 2 LAYERS, LEAK TEST ON EGD WAS NEGATIVE. UNABLE TO COMPLETE THE PARAOESOPHAGEAL HERNIA REPAIR AS PLANNED - PERFORMED GASTROPEXY INSTEAD.

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 CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE LEFT EYE IN THE SURGEON SIDE CART (SSC) WAS NOT WORKING. THE TSE WAS UNABLE TO VIEW THE LIVE LOGS. THE TSE WALKED THE CUSTOMER THROUGH A SYSTEM POWER CYCLE AND A HARD POWER CYCLE OF THE SSC, BUT THE LEFT EYE IMAGE WAS STILL NOT PRESENT. THE TE HAD THE CUSTOMER VERIFY THE FIBER CABLING HAD BLUE LED AT BOTH ENDS AND IT WAS BLUE. THE CUSTOMER WAS UNSURE HOW THEY WOULD PROCEED WITH THE CASE AND WERE ACTIVELY SEARCHING FOR ANOTHER SYSTEM TO UTILIZE. THE CALL ENDED AND THE TSE WAS UNABLE TO TROUBLESHOOT FURTHER. THE PROCEDURE WAS COMPLETION UNKNOWN WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE OR DIRECTOR INFORMED THERE WAS NO HARM TO THE PATIENT IDENTIFIED EXCEPT PROLONGED ANESTHESIA EXPOSURE SINCE WE HAD TO CONVERT TO MULTIPORT. THE CASE WAS CONVERTED TO MULTIPORT FROM A SINGLE PORT SYSTEM. THE CUSTOMER WILL NOT BE DISCLOSING ANY PATIENT 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: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿A SINGLE-CENTER EXPERIENCE OF OVER 300 CASES OF SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY COMPARING THE DA VINCI SP WITH THE SI/XI SYSTEMS¿, THE FOLLOWING EVENTS WERE REPORTED. A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY BETWEEN (B)(6) 2014 AND (B)(6) 2021 AT A SINGLE CENTER WERE INCLUDED IN THE STUDY. IN TOTAL, 334 PATIENTS UNDERWENT SINGLE-INCISION ROBOTIC CHOLECYSTECTOMIES, WITH 118 PATIENTS USING SI/XI SYSTEM AND 216 PATIENTS USING SINGLE PORT (SP). OF THE 216 PATIENTS THAT UNDERWENT SP SURGERIES, TWO PATIENTS IN THE SP GROUP CONVERTED TO MULTIPORT LAPAROSCOPIC SURGERIES. THE CONVERSION WAS DUE TO ONE OF THE PATIENTS HAD ACUTE CHOLECYSTITIS AND THE OTHER HAD SEVERE ADHESIONS FROM PREVIOUS UPPER ABDOMINAL SURGERY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, SUCH AS MASSIVE BLEEDING OR BILE DUCT INJURIES. SEVEN PATIENTS WERE OBSERVED WITH ACUTE INFLAMMATION INTRA-OPERATIVELY. THE ESTIMATED BLOOD LOSS FOR ALL PATIENTS WAS < 50ML, EXCEPT FOR THE CASES THAT REQUIRED CONVERSION TO LAPAROSCOPIC SURGERIES. THE RATE OF POST-OPERATIVE COMPLICATIONS IN 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 DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FRAGMENTS FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGES WERE OBSERVED. THE INSTRUMENT WAS IN USE FOR 15 MINUTES WHEN THE ISSUE HAPPENED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE FRAGMENT WAS JUST ONE BROKEN PIECE WHICH WAS REMOVED SUCCESSFULLY. NO ADDITIONAL PROCEDURES WERE DONE. NO POST OPERATIVE TESTS WERE DONE. A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR HARM. THE PATIENT DID NOT RETURN TO THE HOSPITAL.

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 SYNCHROSEAL INSTRUMENT HAD BOTH "RINGS" FALL OFF. ONE RING WAS RECOVERED, THE SECOND ONE WAS LOST IN SITU. WHEN PULLING OUT THE INSTRUMENT, THE METAL CABLE WAS OBSERVED AT THE DISTAL END OF THE SHAFT. IT WAS REPORTED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS UNKNOWN IF RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND LESS THAN A 15-MINUTE DISPLAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED ADDITIONAL INFORMATION: THE "RING" WAS DESCRIBED AS THE "PROTECTIVE SCREW" AT THE DISTAL END. ADDITIONALLY, AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS RESECTING A LARGE-VOLUME MALIGNANT TUMOR IN THE AREA OF THE MIDDLE PART OF THE MESO ROOT. THE SYNCHROSEAL INSTRUMENT WAS USED FOR DISSECTION AND TO CUT/SEAL SMALLER BLOOD VESSELS. THE FRAGMENT/PART WAS DESCRIBED AS BEING SIMILAR TO A WASHER AND WAS DISCOVERED LYING RETROPERITONEALLY. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO KNOWN COLLISIONS DURING THE PROCEDURE. THE CUSTOMER FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AND CANNULA DAMAGE WAS OBSERVED. A POST-OPERATIVE X-RA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING A SYNCHROSEAL INSTRUMENT WITH AN E-100 GENERATOR DURING A DA VINCI ASSISTED LIVER RESECTION, THE INSTRUMENT WOULD NOT SEAL COMPLETELY, AND THE SURGEON REPORTED BLEEDING. THE CUSTOMER REPLACED THE SYNCHROSEAL INSTRUMENT WITH A VESSEL SEALER EXTEND INSTRUMENT AND USED THE ERBE GENERATOR INSTEAD AND REPORTED IMPROVED SEALING. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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 INGUINAL HERNIA SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF INSIDE THE PATIENT WHILE IN USE. THE INSTRUMENT FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED 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: 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 TRANSTHORACIC ESOPHAGECTOMY WITH CHEST ANASTOMOSIS, THE WASHER ON THE END OF THE SYNCHROSEAL INSTRUMENT CAME OFF INSIDE OF THE PATIENT WHILE IN USE. THE PIECE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO NOTED DAMAGE. THE SURGEON WAS UNCLAMPING TISSUE FOR DISSECTION/BURNING WHEN THE INCIDENT OCCURRED. THE INSTRUMENT WAS USED FOR APPROXIMATELY FIFTEEN MINUTES. THE SURGEON DID NOT NOTE ANY ISSUES WITH FUNCTIONALITY. THE SYNCHROSEAL DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE ISSUE OCCURRED ON THE FIRST INSERTION OF THE INSTRUMENT. NO TESTS WERE PERFORMED TO CONFIRM PIECES AS ALL PARTS WERE VISUALIZED WHEN BROKE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING THE START OF A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR ENERGY WAS NOT AVAILABLE. THE CUSTOMER REPORTED THAT THEY REBOOTED THE ENERGY SHIELD AND THE SYSTEM AND ALL OF THE LED INDICATORS ON THE ENERGY SHIELD WERE BLUE AFTER THE REBOOT. HOWEVER, THE ISSUE RETURNED AND THE LED INDICATORS ON TEH ENERGY SHIELD FLASHED YELLOW AGAIN. THE CUSTOMER CONVERTED THE PROCEDURE TO LAPAROSCOPY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO CONFIRM THAT PORTS WERE PLACED WHEN THE ISSUE WAS IDENTIFIED. THE PORT INCISIONS WERE INCREASED AND/OR ADDITIONAL PORTS WERE PLACED DUE TO THE CONVERSION TO LAPAROSCOPIC 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: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI-ASSISTED ROBOTIC PROCEDURES TITLED, ¿COMPARISON OF SURGICAL OUTCOMES OF ROBOTIC VERSUS CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY OF LARGE UTERUS WITH GYNECOLOGIC BENIGN DISEASE¿ (JEONG, S.Y., ET AL., 2023) THE FOLLOWING EVENTS WERE REPORTED. AS PART OF A RETROSPECTIVE COHORT STUDY AT A SINGLE CENTER BETWEEN JANUARY 2014 AND JULY 2022, A TOTAL OF 397 PATIENTS (197 PATIENTS UNDERWENT ROBOTIC HYSTERECTOMY, 200 PATIENTS UNDERWENT CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY) WHO UNDERWENT MINIMALLY INVASIVE HYSTERECTOMY FOR BENIGN DISEASES WITH UTERINE SIZE EXCEEDING 250G WERE ENROLLED. INTRA-OPERATIVELY, SIX PATIENTS RECEIVED BLOOD TRANSFUSIONS AND 4 PATIENTS HAD URETERAL INJURY. POST-OPERATIVELY, 101 PATIENTS EXPERIENCED URINARY RETENTION WITH CATHETERIZATION WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 1. TRANSFUSION AND ANTIBIOTIC USE WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 2 AND WERE SEEN IN 16 PATIENTS. TWO PATIENTS HAD CLAVIEN-DINDO GRADE 3 POST-OPERATIVE COMPLICATIONS, WITH NO FURTHER DETAILS. THERE IS NO INFORMATION REGARDING THE MEDICAL INTERVENTIONS THAT WERE PERFORMED. INTUITIVE SURGICAL, INC, (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN