Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A 2X11 TS INSERT WAS IMPLANTED. UPDATE (B)(6)2020 WG: SALES BRANCH PROVIDED THE PRIMARY USAGE SHEET. A 2X9 TS INSERT WAS REVISED TO A 2X11 TS INSERT. UPDATE: "PATIENT WAS TREATED WITH I&D DUE TO ACUTE INFECTION. X-RAYS/REMOVED POLYETHYLENE ARE NOT AVAILABLE."

ExcelsiusGPS — 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 REVISION SURGERY WAS DONE TO REMOVE AND REPLACE 4 SCREWS FROM T12 AND L2 THAT WERE NOT PLACED TO PLAN.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6) REPORTED THAT ON DAY 7, AFTER TME FOR RECTAL CANCER PATIENT COMPLAINED OF SUDDEN PURULENT DISCHARGE FROM THE ANUS AND ELEVATED BLOOD TEMPERATURE, SOME WEAKNESS. THIS ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. A DIGITAL EXAMINATION REVEALED A DEFECT OF (1 CM) IN THE POSTERIOR WALL OF COLO-ANAL ANASTOMOSIS. ANTIBIOTICS WERE ADMINISTERED (METRONIDAZOLE-500 MG 3X DAILY AND CEFUROXIME-1 G 3X DAILY) AND SYMPTOMS DISSAPEARED FOR A RESOLUTION DATE OF (B)(6) 2020. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THE EVENT OCCURRED ON (B)(6) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 09-AUGUST-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 ABDOMINOPERINEAL EXCISION SURGICAL PROCEDURE, A SYNCHROSEAL INSTRUMENT PIVOT PIN WASHER DETACHED FROM THE INSTRUMENT AND FELL INSIDE THE PATIENT. IT WAS REPORTED THAT THE WASHER WAS RETAINED WITHIN THE PATIENT. IT WAS ALSO NOTED THAT THE SYNCHROSEAL INSTRUMENT¿S JAW COVER HAD A SPLIT/TEAR. 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 PIVOT PIN WASHER WAS PRESENT DURING INSTRUMENT INSPECTION AND AT THE BEGINNING OF THE PROCEDURE. THE REPORTED ISSUE OCCURRED DURING USE, BUT IT IS UNKNOWN WHAT EXACT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE REPORTED EVENT. THE SURGEON BELIEVED THAT THE CAUSE OF THE REPORTED ISSUE COULD HAVE BEEN A POTENTIAL CLASH WITH ANOTHER INSTRUMENT, HOWEVER THIS WAS NOT CONFIRMED TO BE THE CAUSE OF THE REPORTED EVENT. IT WAS ALSO INDICATED THAT IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT OR OTHER HARD MATERIAL AT THE TIME OF THE REPORTED EVENT. THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR OVER FOUR HOURS WHEN THE REPORTED USE OCCURRED. THE PIVOT PIN WASHER D

Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. THE LOCATION OF THE TARGET WAS LEFT LOWER LOBE. DURING THE CASE, THE INSTRUMENTS USED WERE SUPERD ASPIRATION NEEDLE, TRIPLE NEEDLE BRUSH AND SUPERTRAX FORCEPS. ENDOBRONCHIAL ULTRASOUND AND AN X-RAY WERE PERFORMED ON THE PATIENT. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX, AND THE PATIENT WAS HELD OVERNIGHT. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM 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: DA VINCI CAIDRE GRASPER ARM FELL OFF INSIDE OF PATIENT WHEN JAWS WERE OPENED. A SLOTTED GRASPER WAS INSERTED THROUGH A PORT TO RETRIEVE BROKEN ARM PIECE. SLOTTED GRASPER BROKE AT THE HINGE WHEN JAWS WERE CLOSED ON ARM PIECE. ALL PIECES OBTAINED AND GIVEN TO ASSOCIATE MANAGER. (B)(4), US. 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FEMORAL NOTCHING OCCURRED DURING A ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT INJURY WAS REPORTED.

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR PERFORMED AN I&D INSERT SWAP ON A PATIENT DUE TO INFECTION OF A MAKO RIGHT MEDIAL UNI. ORIGINAL DOS WAS (B)(6) 2020.

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 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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 4 SCREWS AT L2, L3, L5, AND S1 WERE NOT PLACED ACCORDING TO PLAN. THE SCREWS WERE REMOVED AND REPOSITIONED INTRA-OPERATIVELY.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS ANOTHER PREOP CASE IN (B)(6), SCREWS REVISION S1L AND S1R. THE FF WAS ATTACHED IN THE CENTER WITHOUT THE GAP BETWEEN THE DETECTOR AND FF. I HAVE CHECKED THE MARKER'S POSTS ON THE FF AND THE GPS INSTRUMENTS, AND NO BENT POSTS WERE SEEN. DRB AND SM WERE PLACED AS USUAL ON THE RIGHT AND LEFT SIDE. DESPITE A GOOD REGISTRATION SCORE(8,9), WE GOT SHIFT IN THE AP SHOTS. NOTHING WAS MOVED DURING THE REGISTRATION, THE C-ARM WAS BRAKED, AND THE PATIENT AND TABLE WERE NOT MOVED. DURING THE X-RAYS THE MOVEMENT BAR WAS MOVING FROM GREEN TO YELLOW. WE TOOK A SECOND ATTEMPT, AND TRIED TO GET THE SHOTS, HAVING THE GREEN BAR. AFTER NEW LATERAL SHOOTS THE MERGE WAS GOOD, AND WE COULD PROCEED TO THE NAVIGATION. 3. AT THIS POINT THE SM TURNED TO RED AND THEN TO YELLOW, DESPITE NOTHING BEING MOVED OR CHANGED. THE SURGEON CHECKED THE NAVIGATION ACCURACY AT THE SKIN LEVEL AND DECIDED TO DO THE SKIN INCISION, WITHOUT TO RESET THE SM. HE CHECKED THE ACCURACY INSIDE THE WOUND, TAPING THE SPINAL PROCESS AND SCREWS HEADS. THE ACCURACY WAS GOOD, AND SM WAS DEACTIVATED AND ACTIVATED AGAIN AND WAS GREEN. DURING THE CASE, SURGEON CHECKED MULTIPLE TIMES THE NAVIGATION ACCURACY AND IT WAS GOOD. THE CONTROL X

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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION REPORTED.

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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. THE CUSTOMER DOES NOT FEEL THE PNEUMOTHORAX WAS CAUSED BY THE MONARCH PLATFORM. DURING THE CASE, NO AURIS INSTRUMENTS WERE USED. THE INSTRUMENT USED WAS A MEDTRONIC NEEDLE TIPPED CYTOLOGY BRUSH. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX, AND THE PATIENT WAS HOSPITALIZED FOR 2 DAYS. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM HOSPITAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE LEFT L4 SCREW WAS NOT PLACED ACCORDING TO THE SURGICAL PLAN. THE SCREW WAS REMOVED AND REPOSITIONED INTRA-OPERATIVELY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, A PATIENT EXPERIENCED A PNEUMOTHORAX THAT WAS DISCOVERED THREE HOURS AFTER THE PROCEDURE DURING THE POST-OP CHECKS. THE PNEUMOTHORAX WAS LOCATED IN THE LEFT UPPER LUNG WHERE THE TARGET WAS LOCATED. DURING THE CASE, NO AURIS INSTRUMENTS WERE USED. THE INSTRUMENTS USED DURING THE CASE WERE AN OLYMPUS PERIVIEW 21 GAUGE NEEDLE, AND AN OLYMPUS FORCEPS. THE PATIENT WAS HELD OVERNIGHT FOR OBSERVATION, NO OTHER INTERVENTION WAS REQUIRED. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS RELEASED ON THE FOLLOWING DAY.

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. PERFORMED AN I&D AND INSERT SWAP ON THE RIGHT MEDIAL MAKO UNI DUE TO INFECTION.

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.

ExcelsiusGPS — 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 SCREW PLACED AT L5 WAS NOT PLACED ACCORDING TO THE SURGICAL PLAN. THE MISPLACED SCREW WAS REMOVED.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE RIGHT L4 SCREW WAS NOT PLACED ACCORDING TO PLAN. THE SCREW WAS REMOVED AND REPLACED IN THE PROPER POSITION.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT FIVE PEDLCLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT THE LEFT T8-T12 LEVELS. ALL PEAICIE SCREWS FROM T8-T12 AND THE RIGHT SIDE SCREW AT T12 WERE REMOVED AND REPLACED USING TRADITIONAL MIS TECHNIQUE.

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.