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 TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT 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: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ON POST-OPERATIVE DAY #1, THE PATIENT BECAME HYPOTENSIVE AND FELL. AS A RESULT, THE PATIENT ALLEGEDLY BROKE HER VERTEBRAE. THE PATIENT WAS TAKEN BY AMBULANCE TO A NEARBY HOSPITAL (DIFFERENT FROM THE HOSPITAL WHERE THE DA VINCI-ASSISTED SLEEVE GASTRECTOMY WAS PERFORMED). THE PATIENT WAS ADMITTED IN THE ICU. A CT SCAN REVEALED A HEMATOMA. AN ARTERIOGRAM CONFIRMED THERE WAS NO ACTIVE BLEEDING. THE PATIENT UNDERWENT A SECOND PROCEDURE FOR THE BROKEN VERTEBRAE. THE SURGEON REPORTED THAT HE BELIEVES THE POSTOPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL AND WAS RELATED TO AN ALLEGED INSUFFICIENT SEAL INVOLVING THE USE OF A SYNCHROSEAL INSTRUMENT. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING.

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 BY A SURGEON THAT FOLLOWING A SURGERY THAT OCCURRED ON (B)(6) 2022 IT WAS NOTICED THAT THE TRAJECTORIES OF THE ELECTRODES WERE NOT ACCURATE AND CAUSED A SUBDURAL HEMORRHAGE. THE PATIENT IS CLINICALLY STABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT THE BEGINNING OF THE PROCEDURE, THE ROBOT REGISTRATION WENT AS USUAL, THE FRAME REGISTRATION ERROR WAS 0.33 MM AND THE ROBOT REGISTRATION ERROR 0.53 MM. AFTER IMPLANTATION OF THE FIFTH ELECTRODE, I FOUND THAT 4/5 OF THE LENGTHS OF THE ELECTRODES HAD A SYSTEMATIC 5 MM ERROR AND WE TOOK AN O-ARC IMAGE, FROM WHICH IT WAS FOUND THAT ALL BUT ONE ELECTRODE (4/5) WERE 5 MM TOO ANTERIOR TO THE PLAN. THE ELECTRODE, WHICH WAS DESIGNED TO BE ORIENTED, WAS TIPPED SLIGHTLY OBLIQUELY TO THE SKULL BONE, THE MISALIGNED ELECTRODES WERE ALL ORIENTED AT AN ANGLE OF ABOUT 90 DEGREES TO THE SKULL BONE. ANATOMICALLY, HOWEVER, WITH THE EXCEPTION OF ONE ELECTRODE, THE OTHER ELECTRODES APPEARED TO BE STILL IN PLACE. IT WAS DECIDED THAT I MADE A NEW REGISTRATION, AFTER WHICH THE ERROR SEEMED TO BE FIXED. IN A POST-OPERATIVE EXAMINATION, BASED ON THE FUSIONS MADE BY THE PHYSICIST, THE ELECTRODES ARE IN PLACE. AT THE END OF THE PROCEDURE, AN ELECTRODE THAT WAS OUTSIDE THE ANATOMICAL AREA WAS REPLACED. WHEN THE SCREW WAS PLACED IN THE NEW POSITION, NEXT TO THE HOLE IN THE FORMER DRILL, THE THREADS OF THE SCREW CRACK THROUGH THE BONE, THE SCREW SANK INTRACRANIALLY ALONG THE EXTERNAL THREADS AND HAD TO BE REM

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 DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL) (TARGET IN THE LINGULA), AND THE PNEUMOTHORAX WAS DISCOVERED ON THE RIGHT SIDE WHEN THE PHYSICIAN RECEIVED A RADIAL IMAGE AND DIGITAL RADIOGRAPHY (DX). A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL.

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 WHILE USING THE ROSA PLATFORM DURING A TKA SURGERY, THERE WAS AN OVER RESECTION OF TIBIA BY 3MM. A THICKER THAN EXPECTED POLY IMPLANT HAD TO BE USED. NO ADDITIONAL CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: TO COMPARE THE ROBOT TIME/SCREW, RADIATION EXPOSURE, ROBOT ABANDONMENT, SCREW ACCURACY, AND 90-DAY OUTCOMES BETWEEN ROBOT-ASSISTED PERCUTANEOUS AND ROBOT-ASSISTED OPEN APPROACH FOR SHORT LUMBAR FUSION (1-AND 2-LEVEL). THERE IS CONFLICTING LITERATURE ON THE SUPERIORITY OF ROBOT ASSISTED MINIMALLY INVASIVE SPINE SURGERY TO OPEN TECHNIQUES. A LARGE, MULTICENTER STUDY IS NEEDED TO FURTHER ELUCIDATE THE OUTCOMES AND COMPLICATIONS BETWEEN THESE TWO APPROACHES. WE INCLUDED ADULT PATIENTS (=18 YEARS OLD) WHO UNDERWENT ROBOT-ASSISTED SHORT LUMBAR FUSION SURGERY FROM 2015-2019 AT FOUR INDEPENDENT INSTITUTIONS. A PROPENSITY SCORE MATCHING (PSM) ALGORITHM WAS EMPLOYED TO CONTROL FOR THE POTENTIAL SELECTION BIAS BETWEEN PERCUTANEOUS AND OPEN SURGERY. THE MINIMUM FOLLOW-UP WAS 90 DAYS AFTER THE INDEX SURGERY. AFTER PSM, 310 PATIENTS REMAINED. THE MEAN (STANDARD DEVIATION) CHARLSON COMORBIDITY INDEX WAS 1.6 (1.5) AND 53% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSES INCLUDED HIGH GRADE SPONDYLOLISTHESIS (GRADE >2)(48%), DEGENERATIVE DISC DISEASE (22%), AND SPINAL STENOSIS (25%), AND THE MEAN NUMBER OF INSTRUMENTED LEVELS WAS 1.5 (0.5). THE OPERATIVE TIME WAS LONGER IN THE OPEN (198

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: TO COMPARE THE ROBOT TIME/SCREW, RADIATION EXPOSURE, ROBOT ABANDONMENT, SCREW ACCURACY, AND 90-DAY OUTCOMES BETWEEN ROBOT-ASSISTED PERCUTANEOUS AND ROBOT-ASSISTED OPEN APPROACH FOR SHORT LUMBAR FUSION (1-AND 2-LEVEL). THERE IS CONFLICTING LITERATURE ON THE SUPERIORITY OF ROBOT ASSISTED MINIMALLY INVASIVE SPINE SURGERY TO OPEN TECHNIQUES. A LARGE, MULTICENTER STUDY IS NEEDED TO FURTHER ELUCIDATE THE OUTCOMES AND COMPLICATIONS BETWEEN THESE TWO APPROACHES. WE INCLUDED ADULT PATIENTS (=18 YEARS OLD) WHO UNDERWENT ROBOT-ASSISTED SHORT LUMBAR FUSION SURGERY FROM 2015-2019 AT FOUR INDEPENDENT INSTITUTIONS. A PROPENSITY SCORE MATCHING (PSM) ALGORITHM WAS EMPLOYED TO CONTROL FOR THE POTENTIAL SELECTION BIAS BETWEEN PERCUTANEOUS AND OPEN SURGERY. THE MINIMUM FOLLOW-UP WAS 90 DAYS AFTER THE INDEX SURGERY. AFTER PSM, 310 PATIENTS REMAINED. THE MEAN (STANDARD DEVIATION) CHARLSON COMORBIDITY INDEX WAS 1.6 (1.5) AND 53% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSES INCLUDED HIGH GRADE SPONDYLOLISTHESIS (GRADE >2) (48%), DEGENERATIVE DISC DISEASE (22%), AND SPINAL STENOSIS (25%), AND THE MEAN NUMBER OF INSTRUMENTED LEVELS WAS 1.5 (0.5). THE OPERATIVE TIME WAS LONGER IN THE OPEN (19

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED TUBE THORACOSTOMY.

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 DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LUBE (RUL), AND THE PNEUMOTHORAX WAS DISCOVERED WHEN THE PHYSICIAN USED FLUOROSCOPY AND NOTICED THAT THE PATIENT HAD A PNEUMOTHORAX FROM THE IMAGE. A CHEST TUBE WAS PLACED IN THE PATIENT, AND COUPLE HOURS LATER THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE THE ENDOSCOPE (SERIAL NUMBER (SN): (B)(4)) EXPERIENCED COMMUNICATION ISSUES WHEN INSTALLED. THE OPERATING ROOM STAFF RESEATED THE ENDOSCOPE WHEN THE ERRORS OCCURRED, BUT THE ISSUE PERSISTED. THE SITE POWER CYCLED THE SYSTEM, AND WHEN THE ENDOSCOPE WAS REINSTALLED THE ERRORS RETURNED. THE PATIENT BEGAN TO BLEED DURING THE TROUBLESHOOTING AND THE SITE CONVERTED TO OPEN RATHER THAN REPLACING THE ENDOSCOPE. THE PATIENT IS REPORTEDLY IN GOOD HEALTH AFTER THIS PROCEDURE. ON 19-JAN-2022, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE ENDOSCOPE ISSUES OCCURRED AT THE END OF THE PROCEDURE WHEN THE SURGEON WAS REMOVING THE TUMOR. THE PATIENT'S SPLEEN WAS SCRAPED AND ABOUT 50CC'S OF BLOOD WAS LOST IN TOTAL DUE TO THIS EVENT. THE SURGEON SAID THE BLEEDING WAS RESOLVED BY PLACING PRESSURE ON THE TISSUE.

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 DAVINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND RETURNED TO THE FACILITY FOR TREATMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION. ON AN UNSPECIFIED POSTOPERATIVE DAY, THE PATIENT PRESENTED WITH HYPOTENSIVE SYMPTOMS. A CT SCAN REVEALED A HEMATOMA. THE SURGEON STATED HE BELIEVES THE POST-OPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL AND WAS RELATED TO THE USE OF A SYNCHROSEAL INSTRUMENT ON THOSE VESSELS. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING. THE SURGEON STATED HE DOES NOT LIKE HOW THE SYNCHROSEAL CUTS AND HAS TO CUT THE VESSEL MORE THAN ONCE. THE SURGEON INDICATED THAT HE HAS NEVER HAD POST-OPERATIVE BLEEDING INCIDENTS IN HIS PREVIOUS PROCEDURES AND HENCE WILL REVERT TO USING THE VESSEL SEALER EXTEND INSTRUMENT. THE SURGEON CONFIRMED NO SURGICAL INTERVENTION OR BLOOD TRANSFUSIONS WERE RENDERED TO THE PATIENT. HOWEVER, THE PATIENT WAS HOSPITALIZED FOR IV FLUIDS, BLOOD WORK, CT SCAN, AND OBSERVATION.

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 TKA SURGERY WITH ROSA INSTRUMENTATION, THE PLANNED DISTAL FEMUR CUT WAS 7/9.5MM. THE CUT BONE AND VALIDATED CUT WAS OVER RESECTED AT 10/12.5MM. THERE WAS NO ADDITIONAL IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER 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: REFER TO DEVICE MANUFACTUER NARRATIVE 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: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE DEVIATIONS DURING A SCOLIOSIS CORRECTION PROCEDURE FROM T4-L3. THE LEFT SIDE OF THE PATIENT WAS NOTED TO BE CONCAVE. THE FIRST SEGMENT WAS FROM T10-L3 AND A DISPOSABLE CLAMP WAS PLACED ON THE L1 SPINOUS PROCESS. THERE WAS A MEDIAL BREACH AT LEFT L2. THE DEVIATION WAS CONFIRMED WITH AN O-ARM SCAN AND THE PATIENT'S MEP SIGNALS DROPPED SIGNIFICANTLY OVER TIME AFTER FACETECTOMIES WERE DONE. THE SURGEON BELIEVED THE SEGMENT BECAME MOVABLE AND THE MEDIAL SCREW BRUSHED AGAINST THE SPINAL CORD CAUSING THE DROP IN MOTOR RESPONSES. THE SCREW WAS REMOVED. THE SURFACE OF THE BONE WAS FLATTENED PRIOR TO PLACING THE SCREW. ON THE RIGHT SIDE, THERE WAS SOFT TISSUE PRESSURE ON THE L2 AND L3 TRAJECTORIES THAT RESULTED IN THE SURGEON FREE HANDING THOSE TRAJECTORIES. THE SECOND SEGMENT WAS FROM T4-T9 AND A DUAL CLAMP WAS PLACED AT T6 AND T7. ONLY ONE PORTION OF THE CLAMP WAS USED AND THE OTHER PART WAS LOOSE. ALL SCREWS WERE PLACED ACCURATELY ON THE LEFT SIDE, BUT THERE T4-T5 TRAJECTORIES LOOKED MEDIAL. THE SURGEON DECIDED TO FREEHAND T4 AND T5 RIGHT. THE CAUSE OF THE DEVIA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE THE TEFLON PAD MELTED, AND FRAGMENTS WERE FALLING INSIDE THE PATIENT. THE FRAGMENTS WERE NOT RETRIEVED. THE CUSTOMER REMOVED THE INSTRUMENT AND USED A BACKUP INSTRUMENT TO COMPLETE THE PROCEDURE. 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. THE TEFLON PAD MELTED LIKE POWDER AS SOON AS THE CUSTOMER STARTED TO USE THE INSTRUMENT. THE FRAGMENTS WERE NOT RETRIEVED AS THEY WERE NOTED TO BE "LIKE POWDER." IT WAS UNKNOWN WHAT CAUSED THE MELTING TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS, AND THE CUSTOMER CONFIRMED THAT ARCING WAS NOT OBSERVED. THE THYROID TISSUE DID NOT APPEAR TO BE TOO THICK. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED, AND NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICA

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 TKA SURGERY WITH ROSA INSTRUMENTATION THE TIBIA WAS OVER-RESECTED BY 2MM MEDIALLY AND 3.5MM LATERALLY. DUE TO THIS DEVIATION FROM THE SURGICAL PLAN, A 16MM TIBIAL IMPLANT WAS NEEDED WHEN A 10MM IMPLANT WAS PLANNED. PATIENT HAD NO IMPACT AND WAS NOT AFFECTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER 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 DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, HALF OF THE TIP FROM A HARMONIC ACE INSTRUMENT BROKE OFF IN THE ABDOMINAL CAVITY DURING LIVER RESECTION. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. THE SURGEON WAS USING THE HARMONIC ACE INSTRUMENT DURING A PARTIAL LIVER RESECTION. THE CASE WAS ALMOST COMPLETED, BUT THE FRAGMENT BROKE DURING DISSECTION. THE TEAM NOTICED THIS WHEN THE SURGEON WAS MOVING THE INSTRUMENT TO A DIFFERENT AREA OF THE LIVER. THIS CAUSED A 20-30 MINUTE DELAY IN THE CASE. THE FRAGMENT WAS FOUND AND REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE BY USING A LAPAROSCOPIC GRASPER. IT WAS CONFIRMED TO BE REMOVED VISUALLY SO NOT POST-OPERATIVE TESTS WERE NEEDED. BOTH THE FRAGMENT AND THE INSTRUMENT HAVE BEEN GIVEN TO RISK MANAGEMENT. THE CASE WAS LATER CONVERTED TO AN OPEN PROCEDURE DUE TO PATIENT ANATOMY AND NOT DUE TO THE MALFUNCTION OF THE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE PANCREAS WAS INJURED DURING THE INSERTION OF THE AIR-SEAL PORT IN A PATIENT WITH A SMALL BODY HABITUS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SOURCE OF BLEEDING WAS PANCREATIC TISSUE, WHICH WAS DAMAGED WHEN A THIRD-PARTY AIRSEAL PORT WAS INSERTED IN THE PATIENT. THE BLEEDING WAS INITIALLY STOPPED BY APPLYING COMPRESSION AND HEMOSTATIC POWDER. THE SURGEON BELIEVES THAT THE CAUSE OF THE PANCREATIC INJURY WAS DUE TO THE PETITE STATURE OF THE PATIENT AND THE CEPHALAD DIRECTION OF THE INSERTION OF THE AIRSEAL PORT. ACCORDING TO THE SURGEON, THERE WAS NO MALFUNCTION OF AN ISI PRODUCT THAT CAUSED THE PANCREATIC INJURY. AT THE END OF THE PROCEDURE, THE PANCREATIC INJURY, THAT WAS SUSTAINED DURING PORT PLACEMENT, BEGAN TO RE-BLEED. A HEPATOBILIARY PANCREATIC SURGEON WAS CALLED INTO THE OPERATION TO SUTURE THE PANCREAS TO ACHIEVE HEMOSTASIS. THE SURGEON BELIEVES THAT THE CAUSE OF THE RE-BLEEDING WAS DUE TO A PSEUDOANEURYSM FORMED DURING TISSUE DAMAGE, SUTURING, OR DECREASE IN THE INSUFFLATION PRESSURE. NO ADDITIONAL TISSUE RESECTION WAS REQUIR

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 TKA SURGERY USING ROSA INSTRUMENTATION, THE TIBIA WAS OVER-RESECTED BY 3MM POSTERIOR-LATERAL. THIS WAS VALIDATED USING CALIPERS. TISSUE RELEASES AND BONE RECUTS HAD TO BE MADE TO BALANCE THE KNEE. A THICKER POLY HAD TO BE USED THAN WOULD HAVE BEEN THE CASE IF ROSA HAD CORRECTLY CUT THE REQUIRED AMOUNT OF BONE. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS 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 A PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE A SCREW WAS MISPLACED INTRA-OPERATIVELY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOTIC BRONCHOSCOPY: FACTORS ASSOCIATED WITH DIAGNOSTIC ACCURACY OF ROBOTIC BRONCHOSCOPY WITH 12-MONTH FOLLOW-UP: AUTHORS: ABHINAV AGRAWAL, MD, ELLIOT HO, DO, UDIT CHADDHA, MBBS, BARIS DEMIRKOL, MD, SIVASUBRAMANIUM V. BHAVANI, MD, D. KYLE HOGARTH, MD, FCCP, SEPTIMIU MURGU, MD, FCCP. CITATION:DOI:HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2021.12.041. IT WAS REPORTED PNEUMOTHORAX AND PATIENT HOSPITALIZE . NO DEVICE ISSUES WERE REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CONCERNING THE 3 BIOPSIES PERFORMED, THE PROCEDURE DID NOT POSE ANY PARTICULAR PROBLEM, THE FIXATION WAS WITH A MAYFIELD HEAD HOLDER IN CLASSIC DECUBITUS, THERE WAS NO HEMORRHAGIC COMPLICATION OBJECTIFIED AT THE POSTOPERATIVE CONTROL CT SCAN. ON THE OTHER HAND, THE ANALYSIS OF THE SAMPLES WAS NEGATIVE, REQUIRING A SECOND SURGICAL INTERVENTION TO OBTAIN THE DIAGNOSIS, AND THEREFORE A DELAY IN ONCOLOGICAL MANAGEMENT OF ABOUT ONE MONTH.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: MANAGEMENT OF DEGENERATIVE DISEASE OF THE SPINE HAS EVOLVED TO FAVOR MINIMALLY INVASIVE TECHNIQUES, INCLUDING NONROBOTIC-ASSISTED AND ROBOTIC-ASSISTED MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF). VALUE-BASED SPENDING IS BEING INCREASINGLY IMPLEMENTED TO CONTROL RISING COSTS IN THE US HEALTHCARE SYSTEM. WITH AN AGING POPULATION, IT IS FUNDAMENTAL TO UNDERSTAND WHICH PROCEDURE(S) MAY BE MOST COST-EFFECTIVE. TO COMPARE ROBOTIC AND NONROBOTIC MIS-TLIF THROUGH A COST-UTILITY ANALYSIS. WE CONSIDERED DIRECT MEDICAL COSTS RELATED TO SURGICAL INTERVENTION AND TO THE HOSPITAL STAY, AS WELL AS 1-YR UTILITIES. WE ESTIMATED COSTS BY ASSESSING ALL CASES INVOLVING ADULTS UNDERGOING ROBOTIC SURGERY AT A SINGLE INSTITUTION AND AN EQUAL NUMBER OF PATIENTS UNDERGOING NONROBOTIC SURGERY, MATCHED BY DEMOGRAPHIC AND CLINICAL CHARACTERISTICS. WE ADOPTED A WILLINGNESS TO PAY OF $50 000/QUALITY-ADJUSTED LIFE YEAR (QALY). UNCERTAINTY WAS ADDRESSED BY DETERMINISTIC AND PROBABILISTIC SENSITIVITY ANALYSES. COSTS WERE ESTIMATED BASED ON A TOTAL OF 76 PATIENTS, INCLUDING 38 UNDERGOING ROBOT-ASSISTED AND 38 MATCHED PATIENTS UNDERGOING NONROBOTIC MIS-TLIF. USING POINT ESTIMATES,

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 AN INITIAL ROSA INSTRUMENTATION TKA SURGERY BOTH ROSA AND CALIPER VALIDATIONS CONFIRMED THAT THE TIBIA WAS OVER-RESECTED BY 4MM MEDIALLY AND 3MM LATERALLY. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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 TKA PROCEDURE WHILE USING ROSA INSTRUMENTATION, THERE WAS AN OVER RESECTION FROM PLANNED TIBIAL CUT OF 6MM. A 16MM INLAY WAS USED AND THE KNEE WAS STABLE AND WELL BALANCED. AS OF THIS REPORT SUBMISSION THERE HAS BEEN NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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 TKA UTILIZING ROSA INSTRUMENTATION THE TIBIA WAS OVER RESECTED BOTH MEDIALLY AND LATERALLY 4MM. CALIPERS WERE USED TO VERIFY THAT EXCESSIVE BONE REMOVAL HAD OCCURRED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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 TKA SURGERY THE 4-IN-1 CUT WAS NOT ACCURATE AND LED TO AN OVER-RESECTION. THE OVER-RESECTION WAS ENOUGH TO NOTCH THE FEMUR. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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 DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LUBE (RUL), AND THE PNEUMOTHORAX WAS DISCOVERED DURING POST-PROCEDURE CHEST X-RAY. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED FOUR DAYS AFTER THE PLACEMENT AND THE PATIENT WAS DISCHARGED.

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 ESOPHAGECTOMY TRANSTHORACIC-NECK ANASTOMOSIS SURGICAL PROCEDURE, A PIECE OF HARMONIC ACE INSTRUMENT BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER (NURSE) AND OBTAINED ADDITIONAL INFORMATION: THE CUSTOMER DID NOT NOTICE ANY DAMAGE ON THE INSTRUMENT PRIOR TO USE. THE BROKEN PIECE WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOTICS IS A MAJOR AREA FOR RESEARCH AND DEVELOPMENT IN SPINE SURGERY. THE HIGH ACCURACY OF ROBOT-ASSISTED PLACEMENT OF THORACOLUMBAR PEDICLE SCREWS IS DOCUMENTED IN THE LITERATURE. THE AUTHORS PRESENT THE LARGEST CASE SERIES TO DATE EVALUATING 90-DAY COMPLICATION, REVISION, AND READMISSION RATES FOR ROBOT-ASSISTED SPINE SURGERY USING THE CURRENT GENERATION OF ROBOTIC GUIDANCE SYSTEMS. AN ANALYSIS OF A RETROSPECTIVE, MULTICENTER DATABASE OF OPEN AND MINIMALLY INVASIVE THORACOLUMBAR INSTRUMENTED FUSION SURGERIES USING THE MAZOR X OR MAZOR X STEALTH EDITION ROBOTIC GUIDANCE SYSTEMS WAS PERFORMED. PATIENTS 18 YEARS OF AGE OR OLDER AND UNDERGOING PRIMARY OR REVISION SURGERY FOR DEGENERATIVE SPINAL CONDITIONS WERE INCLUDED. DESCRIPTIVE STATISTICS WERE USED TO CALCULATE RATES OF MALPOSITIONED SCREWS REQUIRING REVISION, AS WELL AS OVERALL COMPLICATION, REVISION, AND READMISSION RATES WITHIN 90 DAYS. IN TOTAL, 799 SURGICAL CASES (MAZOR X: 48.81%; MAZOR X STEALTH EDITION: 51.19%) WERE EVALUATED, INVOLVING ROBOT-ASSISTED PLACEMENT OF 4838 PEDICLE SCREWS. THE OVERALL INTRAOPERATIVE COMPLICATION RATE WAS 3.13%. NO INTRAOPERATIVE IMPLANT-RELATED COMPLICATIONS WERE ENCOUNTERED. POSTOP

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: NO NEW INFORMATION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOTICS IS A MAJOR AREA FOR RESEARCH AND DEVELOPMENT IN SPINE SURGERY. THE HIGH ACCURACY OF ROBOT-ASSISTED PLACEMENT OF THORACOLUMBAR PEDICLE SCREWS IS DOCUMENTED IN THE LITERATURE. THE AUTHORS PRESENT THE LARGEST CASE SERIES TO DATE EVALUATING 90-DAY COMPLICATION, REVISION, AND READMISSION RATES FOR ROBOT-ASSISTED SPINE SURGERY USING THE CURRENT GENERATION OF ROBOTIC GUIDANCE SYSTEMS. AN ANALYSIS OF A RETROSPECTIVE, MULTICENTER DATABASE OF OPEN AND MINIMALLY INVASIVE THORACOLUMBAR INSTRUMENTED FUSION SURGERIES USING THE MAZOR X OR MAZOR X STEALTH EDITION ROBOTIC GUIDANCE SYSTEMS WAS PERFORMED. PATIENTS 18 YEARS OF AGE OR OLDER AND UNDERGOING PRIMARY OR REVISION SURGERY FOR DEGENERATIVE SPINAL CONDITIONS WERE INCLUDED. DESCRIPTIVE STATISTICS WERE USED TO CALCULATE RATES OF MALPOSITIONED SCREWS REQUIRING REVISION, AS WELL AS OVERALL COMPLICATION, REVISION, AND READMISSION RATES WITHIN 90 DAYS. IN TOTAL, 799 SURGICAL CASES (MAZOR X: 48.81%; MAZOR X STEALTH EDITION: 51.19%) WERE EVALUATED, INVOLVING ROBOT-ASSISTED PLACEMENT OF 4838 PEDICLE SCREWS. THE OVERALL INTRAOPERATIVE COMPLICATION RATE WAS 3.13%. NO INTRAOPERATIVE IMPLANT-RELATED COMPLICATIONS WERE ENCOUNTERED. POSTOP

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 HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS DISLODGED FROM THE MCS INSTRUMENT AND DROPPED IN THE CAVITY UPON REMOVING THE INSTRUMENT FROM THE PATIENT. THE SCRUB TECHNICIAN NOTICED THAT AND NOTIFIED THE SURGEON IMMEDIATELY. THE SCOPE WAS INTRODUCED AGAIN TO FIND AND RETRIEVE THE MCS TIP COVER ACCESSORY FROM THE BOWELS OF THE PATIENT. 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 ROBOTICS COORDINATOR STATED THAT THEY WERE ABLE TO REMOVE THE MCS TIP COVER WITH ANOTHER DA VINCI INSTRUMENT WITH NO REPOT OF PATIENT INJURY. THERE WERE NO INSTRUMENT FUNCTIONAL ISSUES AND THERE WAS NO ISSUE WITH REMOVING THE MCS FROM THE PATIENT. THEY NOTICED THE MCS TIP COVER ACCESSORY WAS NOT ON THE MCS THE MOMENT THEY REMOVED THE INSTRUMENT FROM THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE ISSUE. ELECTROLUBE WAS USED AFTER THE TIP COVER HAD BEEN INSTALLED; NOT PRIOR TO INSTALLATION. THE ROBOTICS COORDINATOR CLARIFIED THAT THEY ARE CONCERNED WITH USING THE MCS T

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 THERE WERE DEVIATIONS AND THE SURGEON COULD NOT INSTRUMENT DUE TO THE PLATFORM DURING A T3-S2 OPEN PROCEDURE. THE SURGEON PLACED SCREWS FROM LEFT S1 TO L1 AND ALL WERE ACCURATE. ON RIGHT L4, THERE WAS AN INFERIOR SKIVE AND THE PATIENT LOST MOTOR CONTROL AND HAD A CSF LEAK. THE RIGHT TIB, RIGHT EHL, AND RIGHT GASTROC HAD FLATLINED AND THE SURGEON WAS UNABLE TO GET A RESPONSE WHEN STIMULATING. RIGHT L5 AND S1 HAD MEDIAL BEACHES OF 1 CM. A NEUROSURGEON WAS CALLED IN TO HELP REPAIR THE CSF LEAD ALONG WITH THE NERVES. THE SURGEON THEN TRIED TO USE THE SPINOUS PROCESS CLAMP ON L2 AND L4 TO REGISTER L1-S2, BUT THEY WERE UNABLE TO DO SO THEY CONTINUED TO THE NEXT SEGMENT. THE NEXT SEGMENT WAS T7-L1 AND GREEN VALUES COULD NOT BE ACHIEVED FOR T11 DURING REGISTRATION. THE SURGEON DECIDED TO CONTINUE WITH THE OTHER BODIES AND THEY FOUND THAT THEY WERE INFERIOR. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM AND COMPLETE THE PROCEDURE FREEHAND. THE MANUFACTURER REPRESENTATIVE BELIEVED THERE WAS A PATIENT SHIFT THAT RESULTED IN THE ISSUES. THE SURGEON FELT THE SCHANZ

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SYMPTOMATIC BLEEDING COMPLICATION WAS REPORTED ON A TRAJECTORY DEVIATION AT THE ENTRY POINT FOR THE FCA' TRAJECTORY.

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 WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP CAME OFF OF THE MCS INSTRUMENT AND COULD NOT BE LOCATED. AN X-RAY WAS PERFORMED AND THE MCS TIP WAS NOT SEEN. THE INSTRUMENTS WERE REPORTEDLY INSPECTED PRIOR TO THE PROCEDURE AND NOTHING LOOKED OUT OF THE ORDINARY. THERE WAS NO COLLISION WITH ANY OTHER INSTRUMENT OR HARD MATERIALS DURING THE PROCEDURE. IT WAS UNKNOWN HOW LONG THE INSTRUMENT HAD BEEN IN USE WHEN THE ISSUE OCCURRED. ACCORDING TO THE NURSE, SHE AND THE SURGEON FELT THAT THE MCS TIP CAME OFF BECAUSE IT IS NOT ATTACHED TO THE INSTRUMENT AND SHOULD BE MORE SECURE. SHE MENTIONED THAT THE MCS TIP WAS VERY DIFFICULT TO INSTALL AND STATED THAT FUTURE DESIGNS SHOULD HAVE THE TIP PRE-INSTALLED. THE INSTRUMENT WILL NOT BE RETURNED FOR ANALYSIS SINCE THERE WAS NO INSTRUMENT ISSUE, AND THE MCS TIP CANNOT BE FOUND TO BE RETURNED. THE PATIENT HAS NOT RETURNED DUE TO ANY POST-SURGICAL 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: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI-ASSISTED ROBOTIC PROCEDURES TITLED ¿FIRST CASE OF ESOPHAGECTOMY USING A ROBOTIC SINGLE-PORT SYSTEM FOR LARYNGO-ESOPHAGECTOMY¿, THE FOLLOWING EVENTS WERE REPORTED. THE ARTICLE CAPTURES A THORACIC DUCT INJURY WHICH WAS LIGATED WITH AN SP MEDIUM-LARGE CLIP APPLIER TO RESOLVE. ADDITIONALLY, THERE WAS A POST-OPERATIVE ANASTOMOTIC LEAK WITH THE SAME PATIENT; THIS WAS MANAGED WITH VACUUM THERAPY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT A SKILLED SURGEON ATTEMPTED TO USE THE HARMONIC ACE INSERT TO DISSOCIATE TISSUE, BUT THE BLADE WOULD NOT WORK. THE CUSTOMER REPLACED THE HARMONIC ACE INSERT WITH A BACK-UP DEVICE OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE BLADE OF THE HARMONIC ACE INSERT FELL INSIDE THE PATIENT AND WAS RETRIEVED IMMEDIATELY WITH OTHER INSTRUMENTS DURING THE SAME PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO ADDITIONAL SURGICAL INTERVENTION WAS CONDUCTED.

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 CASE IN PROGRESS WITH 45 MM STAPLER. STAPLER CLAMPED DOWN ON TISSUE AND WAS NOT ABLE TO DISCONNECT. SURGEON PRESSED EMERGENCY RELEASE BUTTON ON CONSOLE AND ASSIST USED EMERGENCY SCREW TO UNLOCK STAPLER FROM PATIENT WITH NO SUCCESS. DAVINCI REP CALLED AND CAME IN TO ASSIST. SURGEON WAS ABLE TO REMOVE STAPLER AND PROCEED WITH SURGERY. INSTRUMENT MALFUNCTION. WORKING WITH INTUIT REMOTELY, VENDOR WAS ABLE TO WORK WITH PHYSICIAN TO SUCCESSFULLY DISENGAGE STAPLER FROM BOWEL. INSTRUMENT WAS LABELLED AND REMOVED FROM SERVICE. VENDOR HAS SUBMITTED REQUEST FOR IR. A (B)(6) YEAR OLD MALE WITH QUADRIPLEGIA SUSTAINED AFTER DIVING INTO 3 FT OF WATER. HE UNDERWENT C4-5/6 ACDF WITH PLATING ON (B)(6) 2021. HE WAS INTUBATED FOR RESPIRATORY DISTRESS AND HAD TRACH PLACED (B)(6) 2021. PEG PLACED ON (B)(6) 2021. HIS HOSPITAL COURSE WAS COMPLICATED BY BRADYCARDIA WITH ASYSTOLE, NEUROGENIC SHOCK AND MUCUS PLUGGING. LAST COLONOSCOPY ~ 3 YEARS AGO, HE DOES HAVE A HISTORY OF COLON POLYPS, NO KNOWN FAMILY HISTORY OF COLON CANCER. HISTORY OF UMBILICAL HERNIA REPAIR WITH MESH MANY YEARS AGO. HE IS NOW AT A FACILITY FOR REHABILITATION. WE HAVE BEEN CONSULTED FOR COLOSTOMY TO HELP EASE CARE. HE WISHES TO

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 15-OCT-2021, INTUITIVE BECAME AWARE OF A JOURNAL OF GASTRIC CANCER ARTICLE TITLED, "INTRACORPOREAL ESOPHAGOJEJUNOSTOMY DURING REDUCED-PORT TOTALLY ROBOTIC GASTRECTOMY FOR PROXIMAL GASTRIC CANCER: A NOVEL APPLICATION OF THE SINGLE-SITE® PLUS 2-PORT SYSTEM" (CHOI, S., SON, T., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "ANASTOMOSIS-RELATED COMPLICATIONS WERE OBSERVED IN 2 PATIENTS. THE PATIENT WAS DISCHARGED ON POD 6 AFTER PROXIMAL GASTRECTOMY AND WAS RE-ADMITTED 14 DAYS AFTER DISCHARGE. THE PATIENT DEVELOPED ESOPHAGOJEJUNOSTOMY LEAKAGE, WHICH WAS TREATED WITH ENDOSCOPIC STENT INSERTION. ANOTHER PATIENT DEVELOPED ESOPHAGOJEJUNOSTOMY SITE STENOSIS THAT REQUIRED ENDOSCOPIC DILATATION DURING HOSPITALIZATION, AFTER WHICH THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY (POD) 29. THE OTHER PATIENT WHO UNDERWENT COMPLETION TOTAL GASTRECTOMY DEVELOPED AN INTESTINAL OBSTRUCTION THAT REQUIRED ADDITIONAL SURGERY (LAPAROSCOPIC SEGMENTAL RESECTION OF THE SMALL BOWEL), AFTER WHICH THE PATIENT WAS DISCHARGED ON POD 35." INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A 3RD DEGREE BURN WAS OBSERVED AROUND THE TROCAR SITE WHERE THE CAMERA PORT WAS LOCATED (3¿- 4¿ ABOVE THE UMBILICUS). THERE WAS NO ENERGY USED TO MAKE THE SURGICAL PORT INCISION AND NO REPORT OF ARCING OF ELECTRICAL ENERGY DURING THE CASE. IT WAS BELIEVED THAT BOTH THE PATIENT¿S ANATOMY AND THE DA VINCI INSTRUMENTS AND/OR ACCESSORIES MAY HAVE CONTRIBUTED TO THE BURN. THE PATIENT¿S UTERUS WAS ENLARGED AT 30 CM. IT IS ALLEGED THAT ALONG WITH THE PATIENT¿S SMALL STATURE AND MOVEMENT OF THE INSTRUMENTS DURING THE CASE, AN OCCLUSION MAY HAVE OCCURRED MAKING IT DIFFICULT FOR THE SMOKE TO EVACUATE. THE DA VINCI SYSTEM, INSTRUMENTS AND ACCESSORIES USED DURING THE PROCEDURE WERE INSPECTED PRIOR TO USE, AND NO ABNORMALITIES WERE FOUND. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED AT THE TIME OF THE EVENT. ALSO, THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE BURN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON REASSESSED THE INJURY AT THE PATIENT'S POST-OPERATIVE VISIT TWO WEEKS AFTER THE PROCEDURE. PER THE SURGE

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 IT WAS COMPLETED A 13 TRAJECTORY BILATERAL SEEG CASE USING THE ROSA ROBOT WITH A COMPANY REPRESENTATIVE PRESENT. THE PATIENT WAS PUT TO SLEEP, PINNED IN A MAYFIELD HEAD CLAMP, ATTACHED TO ROSA AND REGISTERED USING CONTACTLESS REGISTRATION. ALL 13 TRAJECTORIES WERE PLACED AS NORMAL. THE COMPANY REPRESENTATIVE THEN RECEIVED AN EMAIL THE NEXT DAY FROM THE SURGEON STATING THAT THE PATIENT HAD A BRAIN HEMORRHAGE THAT WAS SEEN ON A POST OPERATIVE CT SCAN. THE INFORMATION THAT WAS GIVEN WAS THAT THE MAJORITY OF THE ELECTRODES WERE PLACED CORRECTLY, BUT A COUPLE WERE OFF TARGET.

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.

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 THERE WERE IDENTIFIED INACCURACIES AT THE ENTRY POINTS DURING 3 RECENT BIOPSY SURGERIES PERFORMED WITH THE ROSA DEVICE. THE ANALYSIS OF THE SAMPLES WAS NEGATIVE, REQUIRING A SECOND SURGICAL INTERVENTION TO OBTAIN THE DIAGNOSIS, AND THEREFORE A DELAY IN ONCOLOGICAL MANAGEMENT OF ABOUT ONE MONTH.

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 THE PATIENT HAD SEVERE PAIN TWO DAYS AFTER A L5-S1 TLIF PROCURE WAS COMPLETED. IMAGING WAS DONE AND THE RIGHT L5 SCREW WAS DEVIATED BY 1-2 MM INFERIOR. DURING THE PROCEDURE, A SCHANZ PIN WAS PLACED IN THE RIGHT PSIS TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. A MIS CT-FLUORO WORKFLOW WAS FOLLOWED. HIGH SKIVE POTENTIAL WAS NOTED ON THE TRAJECTORIES. THE SURGEON STARTED COMPLETED THE SCREWS IN THE FOLLOWING ORDER: LEFT L5, LEFT S1, RIGHT L5 AND RIGHT S1. WHEN DRILLING L5, THE SURGEON HAD TO USE EXCESSIVE FORCE TO DRILL DUE TO HARD BONE AND DIFFICULTY BREAKING THROUGH THE POSTERIOR WALL. WHEN WORKING ON LEFT L5, THE SURGEON HAD TO RE-ADJUST DURING THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE BELIEVED THE HIGH INFERIOR SKIVE POTENTIAL AND DIFFICULTY DRILLING THE BONE CONTRIBUTED TO THE DEVIATION. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR. A REVISION PROCEDURE WAS DONE TO REMOVE BOTH SCREWS AT L5. THE SURGEON DECIDED NOT TO PLACED SCREWS AT THAT POSITION. THE PATIENT WAS DOING WELL AFTER THE REVISION.

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.