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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO A VERIFICATION ISSUE.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 CALLED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED AN ISSUE WITH THE RIGHT MANIPULATOR. TSE VIEWED THE SYSTEM EVENT LOGS AND NOTICED AN ERROR 23025 POINTING AXIS 3. TSE ASKED HIM TO SHUTDOWN THE SYSTEM AND CYCLE THE SSC BREAKER. AFTER RESTARTING THE ERROR REMAINED. CALLER STATED THAT BEFORE CALLING US THEY HAVE TRIED TO RESTART WITHOUT ANY SUCCESS. TSE EXPLAINED THAT THE RIGHT MANIPULATOR WAS DOWN, AND THE SYSTEM WAS NOT USABLE ANYMORE. SURGEON DECIDED TO CONVERT TO OPEN SURGERY WITH NO REPORTED INJURY. ON JULY 19TH, 2024, INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SURGERY WAS CONVERTED TO OPEN SURGERY. THE CONVERSION RESULTED IN AN INCREASED PORT SIZE INCISION, SPECIFICALLY A MEDIAN SCAR OF AT LEAST 10 CM. THE PATIENT DID TOLERATE THE CHANGE. HOWEVER, IT IS IMPORTANT TO NOTE THAT POSTOPERATIVE FOLLOW-UP AND FUNCTIONAL RESULTS MAY BE COMPROMISED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS NOT ADVANCING PAST THE WHITE "EXCELSIUS" START UP SCREEN.

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 BRANCH BROKE OFF WHILE PREPARING TISSUE FOR NO APPARENT REASON. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DEVICE WAS CHECKED BEFORE USE AND THERE WAS NO DAMAGE OR ANYTHING UNUSUAL. THE FRONT OF THE DEVICE WAS DAMAGED DURING TISSUE PREPARATION. THE SURGEON BELIEVED THAT THE INSTRUMENT BROKE OR THE FRAGMENT FELL FOR NO APPARENT REASON. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 1.5 HOURS BEFORE THE PROBLEM OCCURRED. THE SURGEON DID NOT NOTICE ANY PROBLEMS WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR HARD MATERIALS DURING THE SURGICAL PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT DURING A COLLISION BETWEEN THE INSTRUMENT TIP AND ACCESSORIES. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (BEFORE THE FRACTURE). AFTER THE FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS EXTENDED. NO RESISTANCE WAS FELT WHEN REMOVING THE INSTRUMENT THROUGH THE CA

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 ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. ON POST-OPERATIVE DAY 10, YELLOW LIQUID WITH OBVIOUS ODOR WAS DRAWN FROM THE PRESACRAL DRAINAGE CROWN AND AN ANASTOMOTIC LEAKAGE WAS SUSPECTED BUT NOT CONFIRMED. THE PATIENT UNDERWENT A TREATMENT MODALITY OF NEGATIVE PRESSURE IRRIGATION WHICH RESOLVED THE EVENT. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY 18 AND THERE WERE NO ADVERSE EVENTS AT THE 30-DAY FOLLOW-UP.

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 OF THE 8-12 MM UNIVERSAL SEAL BROKE OFF AND FELL INTO THE PATIENT. THE CUSTOMER STATED THAT THEY WERE ABLE TO REMOVE THE FRAGMENT AND CONTINUE THE PROCEDURE WITHOUT FURTHER ISSUES. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED AND THERE WAS NOTHING FOUND OUT OF THE ORDINARY. THE CUSTOMER STATED THAT THE FRAGMENT WAS RETRIEVED WITH A GRASPER INSTRUMENT. THE SURGEON SAW THE FRAGMENT FALL AND CONFIRMED THERE WAS ONLY ONE. THE PROCEDURE WAS COMPLETED ROBOTICALLY, THERE WERE NO POST OPERATIVE TESTS, AND THE CUSTOMER IS NOT AWARE OF A REPORT INDICATING THE PATIENT RETURNED DUE TO COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. APPROXIMATELY THREE WEEKS LATER, HOME HEALTH VISIT NOTES INDICATE THAT DRAINS WERE REMOVED ON THE PRIOR DAY AND THAT THE PATIENT STATED FEELING PRESSURE ON THE BREAST THE NEXT DAY. THE FOLLOWING DAY, A NURSE CALL NOTED THAT THE PATIENT REPORTED THE RIGHT BREAST FELT HARDER THAN THE OTHER. A CALL WAS THEN PLACED TO THE PLASTICS NURSE PRACTITIONER (NP) WITH THE PATIENT STATING THE RIGHT BREAST FELT ENGORGED. THE PATIENT SENT PICTURES, AND THE NP DETERMINED VISUALLY THERE WERE NO ISSUES AND TO CONTINUE TO MONITOR. FOUR DAYS LATER, THE PATIENT VISITED WITH PLASTICS AND MILD ERYTHEMA TO THE RIGHT BREAST WITH A SMALL PALPABLE FLUID COLLECTION WAS OBSERVED. FIFTEEN CCS OF SEROSANGUINOUS FLUID WERE REMOVED FROM THE RIGHT BREAST AND SENT FOR CULTURE. BACTRIM WAS PRESCRIBED PROPHYLACTICALLY. SURGERY FOR EXPANDER REPLACEMENT WAS SCHEDULED AS THE INVESTIGATOR STATED THAT SHE DIDN'T WANT THE SEROMA TO GET WORSE OR BECOME INFECTED. THE TISSUE EXPANDER REPLACEMENT SURGERY OCCURRED AS PLANNED AND THE PATIENT WAS EXPANDED TO THE SIZE SHE WANTED, ELIMINATING THE NEED FOR AN

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ISSUES WITH SCREW TRAJECTORY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 SCREWS USING THE EXCELSUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS EVENT OCCURRED IN ITALY.

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 SCREWS USING THE EXCELSUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY.

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 RESECTION SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE WHEN THE SURGEON WAS REMOVING THE LIVER PARENCHYMA. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A BACKUP HARMONIC ACE INSTRUMENT TO CONTINUE WITH THE PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE CUSTOMER REMOVED THE FRAGMENT WITH ENDOSCOPIC INSTRUMENTS. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY THE ASSISTANT AND THE NURSE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE FRAGMENT WAS DISCARDED WHEN THE INSTRUMENT WAS STERILIZED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE COHORT STUDY OF 146 PATIENTS WHO UNDERWENT ROBOTIC ASSISTED PANCREATICODUODENECTOMY (RPD) FROM 2014 TO 2021 IN A HIGH-VOLUME CENTER WAS ANALYZED. MAJOR COMPLICATIONS (CLAVIEN-DINDO GRADE GREATER THAN 2) OCCURRED IN 41 PATIENTS (28 PERCENT), WHICH INCLUDED BILIARY FISTULA, CLINICALLY RELEVANT POSTOPERATIVE PANCREATIC FISTULA (CR-POPF), GASTROJEJUNOSTOMY FISTULA, INFECTION, DELAYED GASTRIC EMPTYING (DGE), AND POST PANCREATECTOMY HEMORRHAGE (PPH). AMONG THE PATIENTS THAT EXPERIENCED POST-OPERATIVE COMPLICATIONS, 23 PATIENTS REQUIRED RE-OPERATION. THE DESIGNATED AUTHOR WAS CONTACTED AND CONFIRMED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS IN THE PROCEDURES, NOR DID ANY ISI PRODUCTS CAUSE OR CONTRIBUTE TO THE EVENTS.

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 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: DURING A MONARCH BRONCHOSCOPY PROCEDURE, THERE WAS A SIGNIFICANT CHANGE IN THE PATIENT'S VITAL SIGNS, PROMPTING INTERVENTION BY THE ANESTHESIOLOGIST. THE PATIENT, WHO WAS ELDERLY, EXPERIENCED A CARDIAC EVENT, AND THE PROCEDURE WAS SUBSEQUENTLY ABORTED. THE ATTENDING PHYSICIAN CONFIRMED THAT THE PATIENT HAD SUFFERED A HEART ATTACK. THE PATIENT WAS TRANSFERRED TO THE CATH LAB AND, UNFORTUNATELY, PASSED AWAY LATER THAT DAY. IT IS NOTED THAT THE CLINICAL STAFF DOES NOT ATTRIBUTE THE PATIENT EVENT TO THE MONARCH 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: REFER TO 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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE NOT PLACED DEEP ENOUGH AND HAD TO BE REVISED INTRAOPERATIVELY. THIS EVENT OCCURRED IN ITALY.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY.

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 LITERATURE ARTICLE THAT DESCRIBED AN OBSERVATIONAL STUDY TO EVALUATE THE OUTCOMES OF EVALUATE THE OUTCOMES OF 150 PATIENTS THAT UNDERWENT ROBOTIC PANCREATODUODENECTOMY (RPD) IN A SINGLE-CENTER SETTING, ANALYZING THE PROGRESSION OF THE PROCEDURE¿S COMPLEXITY AND COMPLICATION RATES ACROSS DIFFERENT PHASES OF THE SURGEON'S LEARNING CURVE FROM MARCH 2018 TO APRIL 2023. THE MEAN TOTAL OPERATIVE TIME WAS 402.4 MINUTES WITH A MEDIAN HOSPITAL STAY OF 7 DAYS. THE ARTICLE NOTED SEVERAL ADVERSE EVENTS DURING THESE SURGERIES. 5 PATIENTS REQUIRED CONVERSION TO OPEN SURGERY. BLOOD TRANSFUSIONS WERE GIVEN FOR 10 PATIENTS DURING HOSPITALIZATION. BIOCHEMICAL LEAKAGE WAS OBSERVED IN 42 PATIENTS, AND OVERALL COMPLICATIONS WERE REPORTED IN 30 PATIENTS. THIRTEEN PATIENTS EXPERIENCED COMPLICATIONS OF SEVERITY LEVEL IIIA OR HIGHER BASED ON THE CLAVIEN-DINDO CLASSIFICATION, WHICH INCLUDED EIGHT PATIENTS EXPERIENCED GRADE B POSTOPERATIVE PANCREATIC FISTULA (POPF) AND TWO PATIENTS WITH GRADE C POPF. ONE PATIENT EXPERIENCED WOUND INFECTIONS, AND HEMORRHAGIC COMPLICATIONS OCCURRED IN FIVE PATIENTS: TWO PATIENTS WITH BLEEDING FROM A DUODENOJEJUNOSTOMY SUCCESSFULLY CONTROLLED VIA UPPER ENDOSCOPY AND THREE PAT

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 THREE DAYS AFTER UNDERGOING A DA VINCI-ASSISTED SIGMOID COLECTOMY FOR HIS SIGMOID CANCER, THE PATIENT EXPERIENCED AN INFECTION THAT REQUIRED ANTIBIOTIC TREATMENT AND RESULTED IN A PROLONGED HOSPITALIZATION. THE DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT INTRA-OPERATIVE COMPLICATIONS NOR DEVICE MALFUNCTIONS REPORTED. A THIRD-PARTY 28MM GASTROINTESTINAL STAPLER WAS USED FOR THE END-TO-END ANASTOMOSIS PERFORMED DURING THE PROCEDURE. THREE DAYS LATER, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND A CT-SCAN SHOWED AN ABDOMINAL INFECTION AND THE PATIENT REQUIRED CHANGE OF ANTIBIOTIC REGIMEN WHICH CEFUROXIME WAS SWITCHED TO MEROPENEM, AND INTRAMUSCULAR TRAMADOL. THE STUDY PHYSICIAN BELIEVED THE CAUSE OF THE INFECTION IS RELATED TO PATIENT'S CONDITION OF INCOMPLETE OBSTRUCTION OF THE SIGMOID COLON, INTUSSUSCEPTION AND EXCESSIVE STOOL PRE-OPERATIVELY, AS WELL AS POSSIBILITY OF ANASTOMOTIC LEAKAGE CAUSED BY EXCESSIVE STOOL INFECTION. THE STUDY INVESTIGATOR CONSIDERED THE EVENT AS NOT RELATED TO THE PROCEDURE NOR THE DEVICES.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A REVISION OF T7 TO L2, WITH AN EXTENSION OF FUSION FROM T4 TO T7, USING A "UNID" ROD USING THE CT TO FLUORO WORKFLOW, THERE WAS AN ALLEGED INACCURACY. AFTER DISCUSSING THE CASE WITH THE SURGEON, IT WAS DECIDED THAT THEY WOULD BE PLACING SCREWS IN T4, T5, AND T6, AND REMOVING THE EXISTING HARDWARE AT T7 AND T8 AND REDIRECTING AND REPLACING THE SCREWS AT T7 AND T8. WHILE REGISTERING THE PATIENT TO THE ROBOTIC SYSTEM, THEY HAD GOTTEN SEGMENTATION ON THEIR FIRST AP AND OBLIQUE SHOTS, BUT WHEN IT WENT TO THE REGISTRATION, THEY GOT RED VALUES AT ALL LEVELS (T4-T8). THEY ADJUSTED THE NON-MEDTRONIC IMAGING SYSTEM AND TOOK A NEW OBLIQUE IMAGE AND THEY WERE ABLE TO GET SEGMENTATION AND GREEN VALUES ON THE SECOND REGISTRATION ATTEMPT. THEY CHECKED FOR SHIFTS AND NONE WERE NOTED SO THEY PROCEEDED TO THE OPERATE PORTION. THEY STARTED WITH T4 ON THE RIGHT AND WORKED THEIR WAY DOWN THE RIGHT SIDE, PLACING SCREWS IN T4, T5, AND T6. THE NEUROMONITORING TEAM RAN A MOTOR TEST AFTER THEY PUT IN THE 3 SCREWS ON THE RIGHT SIDE AND THERE WERE NO CHANGES. THE SITE THEN SWITCHED TO

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 WAS MISPLACED USING THE EXCELSIUS GPS SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER A PATIENT, WHO WAS ENROLLED IN A CLINICAL STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE, A BIOPSY CLIP WAS REPORTED AS RETAINED IN THE PATIENT. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL SURGICAL PROCEDURE TO RETRIEVE THE CLIP. THE INITIAL PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT COMPLICATIONS NOR DEVICE MALFUNCTIONS REPORTED. IT WAS LATER FOUND IN THE PATHOLOGY REPORT THAT THE BIOPSY CLIP WAS NOT OBSERVED IN THE SPECIMEN. THE RETRIEVAL OF THE SPECIMEN DURING THE PROCEDURE WAS REPORTED AS SMOOTH WITHOUT ISSUES. A CHEST X-RAY AND ULTRASOUND CONFIRMED THE CLIP WAS RETAINED IN THE PATIENT. AN ADDITIONAL SURGICAL EXCISION OF THE CLIP WAS REQUIRED USING WIRE LOCALIZATION. THE STUDY INVESTIGATOR ASSESSED THIS INCIDENT NOT RELATED TO THE DA VINCI DEVICES BUT RELATED TO THE PROCEDURE ITSELF.

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 LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS OF 23 PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED CYSTECTOMY WITH VARIOUS TYPES OF URINE DERIVATION OF BLADDER CANCER BETWEEN 2021 AND 2024. URINE DIVERSION BY UCS WAS PERFORMED IN 7 PATIENTS, AN ILEAL CONDUIT WAS FORMED USING THE BRICKER METHOD IN 6 PATIENTS, AND ORTHOTOPIC ILEOCYSTOPLASTY ACCORDING TO STUDER WAS PERFORMED IN 10 PATIENTS. IN THE EARLY POSTOPERA­TIVE PERIOD, COMPLICATIONS DEVELOPED IN 9 (39%) PATIENTS WITHIN 1¿16 DAYS AFTER SURGERY. IN MOST CASES, THIS WAS OBSTRUCTIVE PYELONEPHRITIS, WHICH REQUIRED PERCUTANEOUS PUNCTURE NEPHROSTOMY, WHICH CLASSIFIED AS CLAVIEN¿DINDO IIIA. NEPHROSTOMIES WERE CLOSED AFTER THE RESOLUTION OF PYELONEPHRITIS AND RESTORATION OF URINATION. IN ONE PATIENT WHO UNDERWENT CYSTOPROSTATECTOMY WITH EXTENDED PELVIC LYMPHADENECTOMY, LAPAROTOMY WAS PERFORMED ON POSTOPERATIVE DAY 2 DUE TO A DECREASE IN THE HEMOGLO­BIN LEVEL. DURING THE REVISION, DIFFUSE TISSUE HEMORRHAGE WAS DETECTED, WHICH WAS STOPPED USING HEMOSTATIC SPONGES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. MULTIPLE REQUESTS FOR ADDITIONA

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 25-30 MINUTES INTO A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY WITH A DROP IN BLOOD PRESSURE AND HYPOXIA. THE CARDIAC ANESTHESIOLOGIST PERFORMED A TRANSESOPHAGEAL ECHOCARDIOGRAM AND A CO2 GAS EMBOLUS WAS OBSERVED IN THE RIGHT VENTRICLE. THE SURGICAL FELLOW REPORTED THAT THE PATIENT WAS IN A TRENDELENBURG POSITION OF APPROXIMATELY 10 DEGREES AND THE 3RD PARTY INSUFFLATION DEVICE PRESSURE WAS SET TO 12 MMHG. THE PROCEDURE WAS ABORTED; THEY WERE AT THE PROSTATE ENUCLEATION STEP WITH APPROXIMATELY ANOTHER 15-20 MINUTES REMAINING IN THE PROCEDURE. THE PATIENT DECOMPENSATED A SECOND TIME IN THE INTENSIVE CARE UNIT AND EXPIRED ABOUT 4-5 HOURS POST-OPERATIVELY. THE PATIENT HAD A HISTORY OF CARDIAC COMORBIDITIES. THE REPORTED CAUSE OF DEATH WAS CO2 EMBOLUS AND MYOCARDIAL INFARCTION. THE FELLOW STATED THAT THE EVENT WAS NOT CAUSED BY ANY DA VINCI PRODUCT; IT WAS A COMBINATION OF THE PRE-EXISTING CARDIAC CONDITION AND ABSORPTION OF CO2 GAS.

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, DISLODGED TIPS AND WHITE LOOSE PART ON SYNCHOSEAL/EAGLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME 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: WHEN FIRING THE ROBOTIC STAPLING DEVICE IT JAMMED AND LAID DOWN STAPLES, BUT DID NOT CUT THE BOWEL. THE AREA HAD TO BE RESECTED CAUSING SLIGHTLY INCREASED MARGINS.

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 THAT THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP COVER CAME OFF WHEN DISSECTING A PEDICLE. THE SP MCS TIP COVER HAD A GAP BETWEEN THE INSTRUMENT TIP AND SHEATH. THE RUBBER REPORTEDLY CAME OFF, BUT THE BLADE SET STAYED ON. THE SURGEON SPENT 15 MINUTES FINDING THE SP TIP COVER. REPORTEDLY WHEN THE SURGEON HAD EXPERIENCED A LOOSE SP MCS TIP COVER, THE INSTRUMENT WAS REPLACED WITH A NEW SP MCS INSTRUMENT AND TIP COVER. THE PROCEDURE WAS COMPLETED.

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 DURING A ROSA SHOULDER PROCEDURE, REAMING RESULTED IN AN OBLONG HOLE DUE TO HARD BONE. THE SURGEON GRAFTED THE OBLONG DEFECT CREATED BY THE REAMING. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

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 REVIEW OF A LITERATURE ARTICLE CONCERNING A DA VINCI ROBOTIC NIPPLE SPARING MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION (RNSMIBR) WITH GEL IMPLANT WAS PERFORMED. THE AIM OF THE STUDY WAS TO ANALYZE THE EFFECT OF THE DA VINCI ROBOT IN NIPPLE-PRESERVING AREOLA-PRESERVING IMMEDIATE PROSTHETIC BREAST RECONSTRUCTION. SURGERIES WERE REVIEWED BETWEEN THE TIME PERIOD OF SEPTEMBER 2022 TO MAY 2024 USING THE DA VINCI SI AND XI SYSTEMS. A TOTAL OF 116 FEMALE PATIENTS WERE INCLUDED. A TOTAL OF 14 PATIENTS UNDERWENT SURGERY USING THE DA VINCI SI SURGICAL SYSTEM AND 102 PATIENTS UNDERWENT SURGERY USING THE DA VINCI XI SURGICAL SYSTEM. THE ARTICLE STATED THERE WERE "TWO CASES OF IMPLANTS LOSS AND FIVE CASES OF HEAT STEAM-INDUCED SKIN DAMAGE." THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. IT WAS CONCLUDED THAT THE DA VINCI ROBOTIC NIPPLE-PRESERVING AREOLA IMMEDIATE PROSTHESIS BREAST RECONSTRUCTION SURGERY CAN PROVIDE GOOD COSMETIC RESULTS WITHOUT SERIOUS PERIOPERATIVE COMPLICATIONS. ALSO, RNSMIBR CAN PROVIDE BETTER OVERALL AESTHETIC RESULTS AND PATIENT SATISFACTION, AND MAY DECREASE THE RISK OF NIP

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS PI IS FOR THE INITIAL CASE ON 21/JUNE/2024. ON FRIDAY 6/21 THERE WAS A RTHA 4.1 AND THE CUP ENDED UP ALMOST VERTICAL, I WOULD ESTIMATE 60-70 DEGREES OF INCLINATION. I WAS NOT IN THE CASE, BUT FROM WHAT I WAS TOLD BOTH THE ROBOT AND THE BONE WERE RE-REGISTERED. THIS EVENTUALLY LED TO A HIP REVISION ONCE THE PATIENT DISLOCATED.

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 LOW ANTERIOR RESECTION PROCEDURE, AN ABDOMINAL SURGICAL WOUND INFECTION WAS IDENTIFIED 22 DAYS POST-OPERATIVELY. THE NURSE OBSERVED REDNESS, SWELLING, HEAT, AND PAIN AROUND THE WOUND. THE RESIDENT PHYSICIAN EXAMINED THE WOUND, REMOVED ONE STITCH, AND EXPRESSED A LARGE AMOUNT OF FOUL-SMELLING PUS. A WOUND CULTURE WAS TAKEN, AND INSTRUCTIONS WERE GIVEN FOR WOUND PACKING AND DRAINAGE CARE EVERY 8 HOURS. BLOOD TESTS WERE SCHEDULED, AND A BLOOD CULTURE WAS PERFORMED. THE NEXT DAY, A DRAINAGE TUBE WAS PLACED IN THE LEFT ABDOMEN TO DRAIN AN ABDOMINAL ABSCESS. ONE WEEK LATER, THE LEFT ABDOMINAL DRAINAGE TUBE (DRAINAGE FLUID <2ML) WAS REMOVED. THE ATTENDING PHYSICIAN EXAMINED THE SUBJECT AND THE ABDOMINAL WOUND, AND IT WAS NOTED THAT THE SUBJECT COULD BE DISCHARGED IN 2-3 DAYS WITH CONTINUED OBSERVATION. ONE WEEK LATER, THE PATIENT WAS IN GOOD SPIRITS AND WITH GOOD ENERGY. THE WOUND IN THE RIGHT ABDOMEN HAD HEALED WITHOUT FURTHER PUS FORMATION, AND THERE WAS NO FEVER, SO DISCHARGE WAS APPROVED FOR THE SAME DAY. THERE IS NO REPORT THAT A DA VINCI DEVICE MALFUNCTIONED OR CAUSED OR CONTRIBUTED TO THE EVENT.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN JANUARY 2021 AND AUGUST 2023 OF 69 PATIENTS THAT UNDERWENT DA VINCI SINGLE PORT (SP) ASSISTED ROBOTIC HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE (POP) AT TWO TERTIARY CARE CENTERS, PERFORMED BY FIVE TRAINED SURGEONS. THE STUDY WAS CONDUCTED TO EVALUATE THE SHORT-TERM OUTCOMES OF THE PATIENTS UNDERWENT SP ASSISTED HYSTERECTOMY WITH CONCOMITANT SACROCOLPOPEXY POP. THE PROCEDURES WERE ALL COMPLETED EXCEPT FOR ONE CASE OF CONVERSION TO OPEN SURGERY. THE MEDIAN OPERATIVE TIME WAS 209 MINUTES, MEDIAN ESTIMATED BLOOD LOSS WAS 100ML. ONE PATIENT EXPERIENCED A MAJOR VASCULAR INJURY DURING PRESACRAL DISSECTION AND REQUIRED CONVERSION TO LAPAROTOMY. FIVE POST-OPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE WHICH INCLUDED TWO CASES OF SMALL BOWEL OBSTRUCTION, ONE OF THEM WAS RESOLVED BY CONSERVATIVE MANAGEMENT, AND ONE REQUIRED SURGICAL MANAGEMENT. A PATIENT EXPERIENCED PELVIC HEMATOMA REQUIRING A BLOOD TRANSFUSION, AND 1 CASE OF VENTRAL HERNIA THAT REQUIRED SUBSEQUENT REPAIR. ONE PATIENT HAD VAGINAL MESH EXPOSURE, AND THE PATIENT ELECTED TO UNDERGO SURGICAL EXCISION. THERE WAS NO MENTION OF ANY D

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 PROCEDURE, WHILE USING THE HARMONIC ACE CURVED SHEARS INSTRUMENT, AN INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE BROKEN BLADE WAS REMOVED WITH AN UNKNOWN FORCEPS INSTRUMENT DURING THE SAME SURGICAL PROCEDURE. IT WAS CONFIRMED THAT THE FALLEN BLADE WAS NOT CHIPPED AFTER REMOVAL. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY X-RAY DURING SURGERY.

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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE PERFORMED, THE PATIENT EXPERIENCED BLOODY STOOLS ON THE SAME DAY POST-SURGERY. ON POST-OPERATIVE DAY ONE, A COLONOSCOPY FOUND BLEEDING AT THE ANASTOMOSIS SITE. HEMOSTATIC CLIPS WERE APPLIED, AND THE BLEEDING WAS RESOLVED. THERE WERE NO ABNORMAL BOWEL MOVEMENTS AFTER EATING, AND THE SUBJECT WAS DISCHARGED ON POST-OPERATIVE DAY SEVEN. ON POST-OPERATIVE DAY NINE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BLOODY STOOLS, DIZZINESS, AND RESPIRATORY DISCOMFORT. TREATMENT INCLUDED FASTING, ADMINISTRATION OF HEMOSTATIC INJECTIONS, INTRAVENOUS DRIP, AND BLOOD TRANSFUSION. A FEVER WAS IDENTIFIED, AND BLOOD CULTURES WERE DRAWN. A CONSULTATION WITH THE COLORECTAL DEPARTMENT RECOMMENDED CONTINUING THE PREVIOUS TREATMENT AND ARRANGING FOR HOSPITALIZATION. ON POST-OPERATIVE DAY 10, THE PATIENT WAS ADMITTED TO THE WARD AND CONTINUED WITH FASTING, HEMOSTATIC INJECTIONS, ANTIBIOTICS AND A BLOOD TRANSFUSION. ON POST-OPERATIVE DAY 11, THE PATIENT WAS STILL EXPERIENCING BLOODY STOOLS, AND THE PHYSICIAN STATED THERE WAS NO NEED FOR FURTHER SURGERY AT THE MOMENT, AS THE ANASTOMOSIS SITE IS HE

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 LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY THAT ASSESSED THE INTRAOPERATIVE AND SURGICAL OUTCOMES OF 200 PATIENTS BY A SINGLE SURGEON THAT UNDERWENT SINGLE PORT ROBOTIC-ASSISTED SACROCOLPOPEXY (SCP) TO TREAT PELVIC ORGAN PROLAPSE FROM APRIL 2020 TO AUGUST 2023 IN ONE INSTITUTION. ALL PROCEDURES WERE COMPLETED WITHOUT CONVERSIONS TO LAPAROSCOPY OR LAPAROTOMY. INTRAOPERATIVE COMPLICATIONS WERE NOTED AS FIVE INTRAOPERATIVE CYSTOTOMIES; TWO OF THEM OCCURRED DURING THE DISSECTION OF THE VESICOVAGINAL SPACE, AND ALL OF THEM WERE REPAIRED SUCCESSFULLY. THERE WERE 2 CASES OF BOWEL INJURIES, 4 VAGINAL WALL TEAR, AND 1 SACRAL VESSEL INJURY THAT WERE REPAIRED INTRA-OPERATIVELY. POST-OPERATIVELY, FOUR PATIENTS WERE FOUND WITH UMBILICAL WOUND HERNIAS WITH ONE ELECTING SURGICAL REPAIR. A PATIENT WAS FOUND WITH MESH EXPOSURE AND WAS MANAGED CONSERVATIVELY WITH TOPICAL ESTROGEN. THERE WAS NO DA VINCI DEVICE MALFUNCTIONS OR ISSUES MENTIONED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND REMAINING SCREWS WERE THEN PLACED BY HAND.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED DURING SURGERY.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GERLING, M., BAKER, M., STANTON, E., PYUN, J., CHALADOFF, E., PASSIAS, P., <(>&<)> BUSER, Z. (2024). CLOSING THE GAP: THE INCIDENCE OF COMPLICATIONS IN MINIMALLY INVASIVE TUBULAR, ENDOSCOPIC, AND ROBOTIC-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURES. WORLD NEUROSURGERY. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.06.101 SUMMARY: BACKGROUND: THE AIM OF THE CURRENT STUDY WAS TO COMPARE THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS AMONG MINIMALLY INVASIVE SURGERY (MIS) TUBULAR, ENDOSCOPIC, AND ROBOT-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) TECHNIQUES. METHODS: WE STUDIED CONSECUTIVE PATIENTS WHO UNDERWENT SINGLE-LEVEL OR MULTILEVEL TLIF BETWEEN 2020 AND 2022. PREOPERATIVE AND POSTOPERATIVE PATIENT-REPORTED OUTCOMES (VISUAL ANALOG SCALE LEG SCORE AND OSWESTRY DISABILITY INDEX), DEMOGRAPHIC, AND INTRAOPERATIVE VARIABLES WERE RECORDED. ONE-WAY ANALYSIS OF VARIANCE WITH BARTLETT¿S EQUAL-VARIANCE AND PEARSON CHI-SQUARED TESTS WERE USED. RESULTS: THE STUDY INCLUDED 170 TLIF PATIENTS: 107 (63%) TUBULAR, 42 (25%) ENDOSCOPIC, AND 21 (12%) ROBOT ASSISTED. ALL 3 TLIF TECHNIQUES HAD SIMILAR COMPLICATION RATES: TUBULAR 6 (5.6%), ENDOSCOPIC 2 (4.8%), AND ROBOT ASSISTED 1 (4.8%) 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP FRACTURED. THE USER COMPLETED THE PROCEDURE ROBOTICALLY WITH USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THERE WAS NO INSTRUMENT COLLISION. A FRAGMENT FELL INSIDE OF THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE.