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.

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.

At 6:35 p.m. on November 3, 2021, an employee was performing maintenance work on a machine in the automotive engine parts manufacturing facility. As the employee performed maintenance on the tool brush inside the deenergized machine, his upper body was protruding through the part entry door on top of the machine. While working in this position, the energized gantry robot which moves parts to and from the individual machines across the crank shaft line, entered the employee's work zone and struck him. The employee was entangled and caught between the gantry's "grabber hand" and the side of the machine. The employee suffered fatal injuries due to entanglement at the waist level by the gantry and the inside of the machine causing bleeding, contusions, lacerations, and bruises in the upper arms, chest, head and rib cage areas.

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.

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 A PATIENT EXPERIENCED BLEEDING DURING THE BRONCHOALVEOLAR LAVAGE (BAL). THE RIGHT UPPER LOBE (RUL) WAS VISUALIZED AND BLEEDING WAS IDENTIFIED AND ORIGINATED FROM THE POSTERIOR SEGMENT. A DROP IN SATURATIONS REQUIRED MANUAL BAGGING FOR VENTILATION. THE BLEEDING WAS SUCCESSFULLY TREATED WITH EPINEPHRINE AND BALLOON TAMPONADE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO SUBSEQUENT COMPLICATION. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM (OR) AND WAS ADMITTED FOR FURTHER OBSERVATION AND WAS RELEASED 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROID RESECTION SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSERT BROKE OFF AND FELL INSIDE THE PATIENT DURING FIRING. THE FRAGMENT WAS RETRIEVED THROUGH AN ASSISTANT PORT DURING THE SAME PROCEDURE. THE CUSTOMER USED AN ENDOSCOPE AND CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE HARMONIC ACE INSERT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. THE HARMONIC ACE INSERT WAS IN USE FOR APPROXIMATELY 30 MINUTES AND PERFORMED AS INTENDED UP UNTIL THE REPORTED EVENT. THE HARMONIC ACE INSERT WAS REMOVED PRIOR TO AND AFTER THE BREAKAGE WITH NO RESISTANCE THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE HARMONIC ACE INSERT OR CANNULA AFTER THE EVENT OCCURRED. 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) 2021, INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CUSTOMER USED 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 HIATAL-HERNIA PERIESOPHAGEAL SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT DID NOT WORK TO STOP THE BLEEDING. IT IS UNCLEAR WHAT SURGICAL TASK THE SURGEON WAS ATTEMPTING TO PERFORM WHEN THE REPORTED EVENT OCCURRED. THE SURGEON HAD TO SWITCH TO A VESSEL SEALER EXTEND INSTRUMENT TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI EXECUTIVE SALES REPRESENTATIVE (ESR) WHO WAS PRESENT FOR THE PROCEDURE AND OBTAINED ADDITIONAL INFORMATION ON 16-NOV-2021. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SYNCHROSEAL INSTRUMENT WAS NOT SEALING THE SHORT GASTRIC VESSELS ALONG THE GREATER CURVATURE OF THE STOMACH IN THE SYNCH AND SEAL MODES. THE CUTTING FUNCTION WAS WORKING IN THE SYNCH MODE BUT NOT THE SEALING FUNCTION ALTHOUGH THE GENERATOR GAVE THE APPROPRIATE TONES. AS A RESULT, THE VESSELS WERE OOZING/ BLEEDING. THE ESTIMATED BLOOD LOSS WAS LESS THAN 750 ML. THE SURGEON THEN USED A VESSEL SEALER EXTEND INSTRUMENT TO OBTAIN CONTROL AND STOP THE BLEEDING FROM THE SHORT GASTRIC VESSELS. THERE WERE NO ERRORS THAT OCCURRED AT THE TIME OF THE INC

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: ABSTRACT: ACCURATE PEDICLE SCREW PLACEMENT IS CRITICAL TO SURGICALLY CORRECT PEDIATRIC HIGH-GRADE SPONDYLOLISTHESIS (HGS). THE RECENT ADVENT OF ROBOTICS COUPLED WITH COMPUTER-ASSISTED NAVIGATION (RAN) MAY REPRESENT A NOVEL OPTION TO IMPROVE SURGICAL OUTCOMES OF HGS, SECONDARY TO ENHANCED PEDICLE SCREW PLACEMENT SAFETY. THIS SERIES PRESENTS THE HGS-RAN TECHNIQUE ADOPTED BY OUR SITE, DESCRIBING ITS SURGICAL OUTCOMES AND FEASIBILITY. CONSECUTIVE PATIENTS WITH A DIAGNOSIS OF HGS (MEYERDING GRADE III TO V), OPERATED ON USING RAN FROM 2019 TO 2020 AT A SINGLE-CENTER WERE REVIEWED. DEMOGRAPHICS, SCREW ACCURACY, SAGITTAL L5-S1 PARAMETERS, COMPLICATIONS, AND PERIOPERATIVE OUTCOMES WERE DESCRIBED. ALL PATIENTS WERE TREATED WITH INSTRUMENTATION, DECOMPRESSION, POSTERIOR LUMBAR INTERBODY FUSION, AND REDUCTION. ROBOTIC TIME INCLUDED ANATOMIC REGISTRATION TO END OF SCREW PLACEMENT. SCREW ACCURACY, DEFINED AS A SCREW PLACED SAFELY WITHIN THE PLANNED INTRAPEDICULAR TRAJECTORY WAS CHARACTERIZED BY THE GERTZBEIN-ROBBINS SYSTEM FOR PATIENTS WITH ADDITIONAL 3-DIMENSIONAL IMAGING. TEN HGS PATIENTS, WITH AN AVERAGE AGE OF 13.7 YEARS OLD, WERE INCLUDED IN THE SERIES. ALL 62 SCREWS WERE PLACED WITHOUT NEU

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 ROBOTIC INSTRUMENTATION THE SURGEON PLANNED FOR TIBIA 0 DEGREE V/V CUT BUT ENDED UP IN 7 DEGREE VARUS (FROM POST-OP X-RAY). THE ROBOTIC SYSTEM SUGGESTED TIBIA BONE CUT OF 11.5MM ON LATERAL AND 9MM ON MEDIAL. THE VERIFIED CUT WAS 9MM MEDIAL AND 12MM LATERAL. VERIFICATION SHOWED 1 DEGREE OF VALGUS. FROM PRE-OP X-RAY TEMPLATING, SURGEON SHOULD HAVE CUT 12MM ON LATERAL AND 4MM ON MEDIAL TO GET THE KNEE STRAIGHT. NO MID SURGERY INTERVENTION OCCURRED. SURGEON EXECUTED THE SURGERY THAT WAS ORIGINALLY PLANNED. NO KNOWN IMPACT OR CONSEQUENCE 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 DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE METAL TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF. THE FRAGMENT WAS RETRIEVED DURING THE PROCEDURE. THE CUSTOMER WAS TAKING OUT TISSUE WHEN THE INSTRUMENT BROKE. THE INSTRUMENT WRIST STRAIGHTENED UPON REMOVAL. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS. 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.

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 EXPERIENCED A SMALL PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE PNEUMOTHORAX WAS LEFT UPPER LOBE (LUL). THE PNEUMOTHORAX WAS TREATED EXPECTANTLY WITH OXYGEN AND HOSPITALIZATION ON (B)(6) 2021. A SECOND CHEST X-RAY WAS TAKEN, AND PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ZIMMER BIOMET MEDTECH HAS BEEN MADE AWARE OF A SERIOUS ADVERSE EVENT THAT OCCURRED AT THE HOUSTON VA, IN WITH ROBOT S/N (B)(6). A SYSTEMATIC REGISTRATION ERROR APPEARED TO BE PRESENT WITH AN INTRAOPERATIVE O-ARM SPIN. THE DAY OF THESE CASE, WEDNESDAY (B)(6), AN INACCURACY OCCURRED. ON THE FOLLOWING DAY, THE (B)(6), THE PATIENT HAD AN INTRAPARENCHYMAL HEMATOMA OF ABOUT 2 CM IN SIZE. THE PATIENT IS ANTICIPATED TO MAKE A FULL RECOVERY.

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, TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT IN THE SAME PROCEDURE. THE FRAGMENT AND THE INSTRUMENT WILL BE RETURNED FOR EVALUATION. THEY WERE DISSECTING WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THERE WAS NO TIP OR INSTRUMENT COLLISION. THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ORIGINAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ON 15-NOV-2021. THE INSTRUMENT WAS INSPECTED IN THE NORMAL PRE-OPERATION INSPECTION AND NOTHING OUT OF THE ORDINARY WAS NOTED. THE INSTRUMENT WAS USED FOR APPROXIMATELY 1.5 HOURS. THE FRAGMENT WAS RETRIEVED BY THE BEDSIDE ASSIST USING A LAPARSCOPIC INSTRUMENT. BOTH THE INSTRUMENT AND THE FRAGMENT WERE GIVEN TO THE MATERIALS DEPARTMENT TO COMPLETE THE RETURN. NO INJURY WAS OBSERVED TO THE PATIENT AT THE TIME OF THE ISSUE. HE WAS NOT AWARE IF ANY POST-OPERATIVE TESTS WERE PERFORMED TO VERIFY ALL FRAGMENTS WERE RETRIEVED AND HE WAS NOT AWARE IF THE PATIENT HAD EXPERIENCED ANY POST-SURGICAL COM

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 LOCATION OF THE TARGET AND PNEUMOTHORAX WAS LEFT UPPER LOBE. IN ADDITION TO THE PNEUMOTHORAX, THE PATIENT SUFFERED AN ALLERGIC REACTION TO ANESTHETIC. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED ON (B)(6) 2021.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MPS REPORTED ROBOT ISSUES. MPS REPORTED REAMING THROUGH MEDIAL WALL AND OTHER ISSUES. AS REPORTED VIA COMPLAINT FORM: AFTER IMPACTION, 48 CUP WOULD NOT STICK. SURGEON INDICATED THAT POSTERIOR WALL MAY HAVE BEEN REAMED THROUGH. SURGICAL DELAY = 15 MINUTES. CASE COMPLETED MANUALLY. CASE TYPE / APPLICATION: THA 4.0. UPDATE: ADDITIONAL INFORMATION RECEIVED FROM MPS: "THE SURGEON INDICATED THAT SHE DID NOT NOTICE THE POSTERIOR MEDIAL WALL HAVING DAMAGE UNTIL AFTER CUP IMPACTION. ANOTHER SURGEON WHO HELPED HER WITH THE REPAIR/AUGMENT STATED THAT HE BELIEVED IT MAY HAVE BEEN CAUSED DURING CUP IMPACTION IN COMBINATION WITH A THIN MEDIAL WALL AS OPPOSED TO THE REAMING PORTION."

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) AND LOW ANASTOMOSIS ON (B)(6) 2021, THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY (POD) #2, THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION ON POD #13. THE UMBILICAL INCISION HAD ECCHYMOSIS CONSISTENT WITH PRESSURE FROM THE ROBOT AND SOME SEROUS DRAINAGE WAS OBSERVED. THE INCISION WAS OPENED, AND THE SEROSANGUINOUS DRAINAGE WAS EXPELLED. THE WOUND WAS THEN PACKED WITH ½-INCH IODOFORM, COVERED WITH 4X4 GAUZE. THE INFECTION WAS RESOLVED BY POD #43.

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 A SINGLE LEVEL MIS TLIF AT L4-L5 PROCEDURE WAS PLANNED. AFTER THE RIGHT L5 GUIDEWIRE WAS INSERTED, THE SURGEON REALIZED THERE WAS SOMETHING WRONG WHEN INSERTING THE RIGHT L4 GUIDEWIRE. IMAGING WAS DONE WITH THE C-ARM AND THE SURGEON FOUND THEY WERE NOT IN THE PLANNED TRAJECTORIES. THE SCREWS INTENDED FOR L5 WERE AT L4 AND THE SURGICAL ARM WAS SENT TO THE WRONG LEVEL. TROUBLESHOOTING INVOLVED CHECKING THE PLAN AND LABELING AND RESENDING THE SURGICAL ARM TO THE TRAJECTORY. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM AND COMPLETE THE PROCEDURE FREEHAND USING THE C-ARM. THE PATIENT'S L3 EXITING NERVE ROOT WAS DAMAGED, BUT THE PATIENT'S MOTOR FUNCTION WAS NOT IMPACTED. THE PATIENT WAS STILL UNDER OBSERVATION. THE PROCEDURE WAS DELAYED TWO HOURS.

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 REPOSITION A MISPLACED L5 RIGHT SCREW.

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 BY THE SITE¿S ROBOTIC COORDINATOR TO INTUITIVE SURGICAL INC, (ISI) CUSTOMER SERVICE, THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, THE SYNCHROSEAL INSTRUMENT ALLEGEDLY MISFIRED AND DID NOT ADEQUATELY SEAL A VESSEL. AS A RESULT, BLEEDING WAS OBSERVED. ON 02-NOV-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM A SITE ROBOTICS NURSE, STEMMING FROM INFORMATION PROVIDED BY OPERATING ROOM (OR) STAFF WHO WERE PRESENT FOR THE CASE: THE SYNCHROSEAL INSTRUMENT DID NOT ACTIVATE AT ONE TIME DURING THE SURGICAL PROCEDURE BUT THE PHYSICIAN CONTINUED TO USE THE DEVICE. A SECOND BACKUP INSTRUMENT WAS NOT OPENED AND USED DURING THE CASE. THE ROBOTICS NURSE IS UNSURE OF THE AMOUNT OF BLOOD LOSS AND CONFIRMED THAT THE INSTRUMENT WAS RETURNED FOR EVALUATION. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY PROCEDURE, DURING "VASCULARIZATION" OF THE HILAR REGION OF THE LUNG, THE PATIENT EXPERIENCED BLEEDING. THE CAUSE OF THE BLEEDING WAS NOT DISCLOSED. THE SURGEON COULD NOT CONTROL THE BLEEDING; MEDIUM-LARGE CLIPS WERE USED TO IN AN ATTEMPT TO CONTROL THE BLEED WITHOUT SUCCESS. AS A RESULT, THE SURGEON DECIDED TO CONVERT TO OPEN CHEST SURGERY. ON 25-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED RIGHT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING DURING HILAR VASCULAR TREATMENT WITH THE SYNCHROSEAL INSTRUMENT. THE SURGEON INDICATED THAT THE CAUSE OF THE BLEED MIGHT HAVE BEEN RELATED TO "TENSION" OR DAMAGE TO AN UNSPECIFIED VESSEL WHEN "PEELING" AND "NOT CUTTING" WITH THE SYNCHROSEAL INSTRUMENT. IT IS UNCLEAR WHAT THE SURGEON MEANT BY "PEELING." THE SURGEON TRIED TO STOP THE BLEEDING WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT AND SUCTIONING. THE SURGEON APPLIED JUST ONE CLIP BUT WAS UNABLE TO PLACE A SECOND CLIP FOR AN UNKNOWN REASON. THE SURGEON COULD NOT CONTROL THE BLEEDING. DUE TO THE

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 A MISPLACED LEFT SIDE SCREW FROM THE INITIAL OPERATION. THIS EVENT OCCURRED IN (B)(6).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF A BRITISH JOURNAL OF SURGERY (BJS) OPEN ARTICLE TITLED, ¿OUTCOMES OF ROBOTIC LOW ANTERIOR RESECTION VERSUS TRANSANAL TOTAL MESORECTAL EXCISION FOR RECTAL CANCER¿ (BUAN, J. L. B., SO, W. Z., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING ROBOTIC LOW ANTERIOR RESECTION (RLAR) PROCEDURES WERE NOTED. PER THE ARTICLE, THE FOLLOWING WAS NOTED: "RLAR WAS PERFORMED WITH THE DA VINCI SI VR (INTUITIVE SURGICAL, SUNNYVALE, CALIFORNIA, USA) SYSTEM IN TWO PHASES, WITH REDOCKING AS STANDARD PRACTICE AT THIS INSTITUTION," AND, "IN THE RLAR GROUP SIX PATIENTS HAD COMPLICATIONS OF GRADE III AND ABOVE, OF WHOM FOUR HAD ANASTOMOTIC LEAKS, ONE HAD A POSTOPERATIVE BILOMA FROM A SYNCHRONOUS LIVER RESECTION, AND ONE HAD NARROWING OF THE AFFERENT LIMB OF THE DE-FUNCTIONING ILEOSTOMY THAT REQUIRED SURGICAL REVISION." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION: THE AUTHOR WAS UNABLE TO PROVIDE THE NAMES OF THE SURGEONS BUT CONFIRMED THAT THE STUDY HAD (B)(6) SURGEONS INVOLVED IN THESE CASES. WITH REGARDS TO THE PATIENT WITH THE BILOMA, THE PATIENT REQUIRED A LIVER RESECTION DUE TO LIVER META

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF A BRITISH JOURNAL OF SURGERY (BJS) OPEN ARTICLE TITLED, ¿OUTCOMES OF ROBOTIC LOW ANTERIOR RESECTION VERSUS TRANSANAL TOTAL MESORECTAL EXCISION FOR RECTAL CANCER¿ (BUAN, J. L. B., SO, W. Z., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING ROBOTIC LOW ANTERIOR RESECTION (RLAR) PROCEDURES WERE NOTED. PER THE ARTICLE, THE FOLLOWING WAS NOTED: "RLAR WAS PERFORMED WITH THE DA VINCI SI VR (INTUITIVE SURGICAL, SUNNYVALE, CALIFORNIA, USA) SYSTEM IN TWO PHASES, WITH REDOCKING AS STANDARD PRACTICE AT THIS INSTITUTION," AND, "IN THE RLAR GROUP SIX PATIENTS HAD COMPLICATIONS OF GRADE III AND ABOVE, OF WHOM FOUR HAD ANASTOMOTIC LEAKS, ONE HAD A POSTOPERATIVE BILOMA FROM A SYNCHRONOUS LIVER RESECTION, AND ONE HAD NARROWING OF THE AFFERENT LIMB OF THE DE-FUNCTIONING ILEOSTOMY THAT REQUIRED SURGICAL REVISION." ONLY ONE OF THE PATIENTS WHO EXPERIENCED AN ANASTOMOTIC LEAK REQUIRED A RE-OPERATION IN WHICH THE PELVIC ABSCESS WAS DRAINED TRANSANALLY AND THE LEAK WAS MANAGED WITH THE ENDO-SPONGEVR SYSTEM. ADDITIONALLY, PER THE JOURNAL ARTICLE, THE FOLLOWING IS NOTED: "DISTAL TRANSECTION WAS PERFORMED WITH ENDOSCOPIC

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: PEDICLE SCREW INSERTION FOR STABILIZATION AFTER LUMBAR FUSION SURGERY IS COMMONLY PERFORMED BY SPINE SURGEONS. WITH THE ADVENT OF NAVIGATION TECHNOLOGY, THE ACCURACY OF PEDICLE SCREW INSERTION HAS INCREASED. ROBOTIC GUIDANCE HAS REVOLUTIONIZED THE PLACEMENT OF PEDICLE SCREWS WITH 2 DISTINCT RADIOGRAPHIC REGISTRATION METHODS, THE SCAN AND PLAN METHOD AND CT-TO-FLUOROSCOPY METHOD. IN THIS STUDY, THE AUTHORS AIMED TO COMPARE THE ACCURACY AND SAFETY OF THESE METHODS. A RETROSPECTIVE CHART REVIEW WAS CONDUCTED AT 2 CENTERS TO OBTAIN OPERATIVE DATA FOR CONSECUTIVE PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR PEDICLE SCREW PLACEMENT. THE NEWEST ROBOTIC PLATFORM (MAZOR X ROBOTIC SYSTEM) WAS USED IN ALL CASES. ONE CENTER USED THE SCAN-AND-PLAN REGISTRATION METHOD, AND THE OTHER USED CT-TO-FLUOROSCOPY FOR REGISTRATION. SCREW ACCURACY WAS DETERMINED BY APPLYING THE GERTZBEIN-ROBBINS SCALE. FLUOROSCOPIC EXPOSURE TIMES WERE COLLECTED FROM RADIOLOGY REPORTS. OVERALL, 268 PATIENTS UNDERWENT PEDICLE SCREW INSERTION, 126 PATIENTS WITH SCAN-AND-PLAN REGISTRATION AND 142 WITH CT-TO-FLUOROSCOPY REGISTRATION. IN THE SCAN-AND-PLAN COHORT, 450 SCREWS WERE INSERTED ACROSS 266 SPINAL LEVELS (MEAN

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 A FEW HOURS AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXHIBITED SIGNS OF A LEAK. THE PATIENT HAD 4.5 L OF BLOOD IN HIS STOMACH THAT WAS DRAINED IN A SUBSEQUENT PROCEDURE. ON 15-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS AN AFRICAN AMERICAN MALE, WEIGHING (B)(6) LBS, WITH A MEDICAL HISTORY OF OBESITY, SLEEP APNEA, AND HYPERTENSION. IT WAS REPORTED THAT A FEW HOURS AFTER A DA VINCI ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND HE EXHIBITED SIGNS OF INTERNAL BLEEDING. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY, AND APPROXIMATELY 4.5 LITERS OF BLOOD WAS IDENTIFIED IN HIS STOMACH. THE SURGEON REMOVED THE CLOTS AND DRAINED THE BLOOD. AS A PRECAUTION, SHE PLACED CLIPS ON THE STAPLE LINES, APPLIED SURGICEL ON THE SEAL OF THE SHORT GASTRIC ARTERY, AND SEALED THE OMENTUM WITH A HARMONIC SCALPEL INSTRUMENT. THE SURGEON COULD NOT CONFIRM THE SOURCE OF THE BLEEDING; HOWEVER, SHE BELIEVES IT COULD HAVE BEEN DUE TO SPASM OF THE SHORT GASTRIC ARTERY RIGHT AFTER THE PROCEDURE, WHICH COULD H

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: PEDICLE SCREW INSERTION FOR STABILIZATION AFTER LUMBAR FUSION SURGERY IS COMMONLY PERFORMED BY SPINE SURGEONS. WITH THE ADVENT OF NAVIGATION TECHNOLOGY, THE ACCURACY OF PEDICLE SCREW INSERTION HAS INCREASED. ROBOTIC GUIDANCE HAS REVOLUTIONIZED THE PLACEMENT OF PEDICLE SCREWS WITH 2 DISTINCT RADIOGRAPHIC REGISTRATION METHODS, THE SCAN AND PLAN METHOD AND CT-TO-FLUOROSCOPY METHOD. IN THIS STUDY, THE AUTHORS AIMED TO COMPARE THE ACCURACY AND SAFETY OF THESE METHODS. A RETROSPECTIVE CHART REVIEW WAS CONDUCTED AT 2 CENTERS TO OBTAIN OPERATIVE DATA FOR CONSECUTIVE PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR PEDICLE SCREW PLACEMENT. THE NEWEST ROBOTIC PLATFORM (MAZOR X ROBOTIC SYSTEM) WAS USED IN ALL CASES. ONE CENTER USED THE SCAN-AND-PLAN REGISTRATION METHOD, AND THE OTHER USED CT-TO-FLUOROSCOPY FOR REGISTRATION. SCREW ACCURACY WAS DETERMINED BY APPLYING THE GERTZBEIN-ROBBINS SCALE. FLUOROSCOPIC EXPOSURE TIMES WERE COLLECTED FROM RADIOLOGY REPORTS. OVERALL, 268 PATIENTS UNDERWENT PEDICLE SCREW INSERTION, 126 PATIENTS WITH SCAN-AND-PLAN REGISTRATION AND 142 WITH CT-TO-FLUOROSCOPY REGISTRATION. IN THE SCAN-AND-PLAN COHORT, 450 SCREWS WERE INSERTED ACROSS 266 SPINAL LEVELS (MEAN

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: PEDICLE SCREW INSERTION FOR STABILIZATION AFTER LUMBAR FUSION SURGERY IS COMMONLY PERFORMED BY SPINE SURGEONS. WITH THE ADVENT OF NAVIGATION TECHNOLOGY, THE ACCURACY OF PEDICLE SCREW INSERTION HAS INCREASED. ROBOTIC GUIDANCE HAS REVOLUTIONIZED THE PLACEMENT OF PEDICLE SCREWS WITH 2 DISTINCT RADIOGRAPHIC REGISTRATION METHODS, THE SCAN-AND-PLAN METHOD AND CT-TO-FLUOROSCOPY METHOD. IN THIS STUDY, THE AUTHORS AIMED TO COMPARE THE ACCURACY AND SAFETY OF THESE METHODS. A RETROSPECTIVE CHART REVIEW WAS CONDUCTED AT 2 CENTERS TO OBTAIN OPERATIVE DATA FOR CONSECUTIVE PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR PEDICLE SCREW PLACEMENT. THE NEWEST ROBOTIC PLATFORM (MAZOR X ROBOTIC SYSTEM) WAS USED IN ALL CASES. ONE CENTER USED THE SCAN-AND-PLAN REGISTRATION METHOD, AND THE OTHER USED CT-TO-FLUOROSCOPY FOR REGISTRATION. SCREW ACCURACY WAS DETERMINED BY APPLYING THE GERTZBEIN-ROBBINS SCALE. FLUOROSCOPIC EXPOSURE TIMES WERE COLLECTED FROM RADIOLOGY REPORTS. OVERALL, 268 PATIENTS UNDERWENT PEDICLE SCREW INSERTION, 126 PATIENTS WITH SCAN-AND-PLAN REGISTRATION AND 142 WITH CT-TO-FLUOROSCOPY REGISTRATION. IN THE SCAN-AND-PLAN COHORT, 450 SCREWS WERE INSERTED ACROSS 266 SPINAL LEVELS (MEAN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AN INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SERVICE (CS) REPRESENTATIVE RECEIVED AN INCOMING CALL AND IT WAS INITIALLY REPORTED THAT AN UNSPECIFIED PATIENT HAD A DA VINCI SURGERY FOR UTERUS REMOVAL AND THAT SHE HAD PHYSICAL CHANGES AFTERWARDS TO HER STOOL, HER SLEEP PATTERNS, AND HER URINARY CONTINENCE. WHEN ADDITIONAL DETAILS WERE REQUESTED, THEY WERE REFUSED BY THE INITIAL REPORTER. NO HOSPITAL, SURGEON, PROCEDURE DATE/DATE RANGE, OR PATIENT INFORMATION WAS ABLE TO BE OBTAINED. ISI HAS REACHED OUT TO THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

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 A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIAL RESECTIONS WERE AROUND 4-4.5 MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY (14MM) THAN PLANNED (10MM) WITH NO KNOWN REPORTED IMPACT TO THE PATIENT. PATIENT WAS PAIN FREE AND DISCHARGED 3 DAYS POST OP. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS INCIDENT.

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 BY A DOCTOR THAT AFTER A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A URETERAL STRICTURE OCCURRED AND WAS PROBABLY DUE TO HEAT DAMAGE. THE DOCTOR SPECULATES THAT HEAT WAS TRANSFERRED FROM THE WRIST OF THE SYNCHROSEAL INSTRUMENT TO THE URETER AND THAT THERMAL DAMAGE TO THE URETER CAUSED A STRICTURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON FROM THE SITE AND OBTAINED THE FOLLOWING INFORMATION ON (B)(6) 2021. THE SYNCHROSEAL INSTRUMENT WAS EXAMINED BEFORE USE AND THERE WERE NO ABNORMALITIES SEEN. THE SURGEON DID NOT HAVE ANY ISSUES USING THE SYNCHROSEAL INSTRUMENT AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DETECTED DURING THE PROCEDURE. THE JAWS OF THE SYNCHROSEAL INSTRUMENT WERE NOT IMMERSED IN CONDUCTIVE FLUIDS AND DID NOT COME INTO CONTACT WITH ANY NON-TARGET TISSUE OR METALLIC OBJECTS WHILE ENERGIZED. ADDITIONALLY, THE SYNCHROSEAL INSTRUMENT WAS NOT USED TO ENERGIZE THE TIPS OF OTHER INSTRUMENTS AND THE SURGEON HAD GOOD VISIBILITY OF THE JAWS AS WELL AS THE ANATOMY SURROUNDING THE INSTRUMENT DURING SYNCHROSEAL ACTIVATIONS. THERE WAS NO ARCING/BURNING SEEN. THE SURGEON CONFI