da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A PLANNED DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AFTER DOCKING DUE TO THE LEFT EYE ON A 0-DEGREE ENDOSCOPE BEING BLURRY. THE CUSTOMER TRIED TO TROUBLESHOOT BY REPLACING THE ENDOSCOPE, BUT THE IMAGE WAS STILL BLURRED. THE TSE HAD THE CUSTOMER POWER CYCLE AND HARD CYCLE THE VISION SIDE CART (VSC) BUT THE IMAGE WAS STILL NOT COMING UP NORMALLY. THE TSE HAD THE CUSTOMER VERIFY THE IMAGE WAS BAD ON THE VSC AS WELL AS ON THE SURGEON SIDE CART (SSC). THE SURGEON OPTED TO CANCEL THE CASE. THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS FINE. THERE WERE NO COMPLICATIONS OR PATIENT INJURY POST-ANESTHESIA. THEY JUST HAD TO WAKE UP THE PATIENT AS THERE WAS NO SCOPE TO USE.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

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 WAS AN ALLEGED INACCURACY. THE SITE WAS OPERATING FROM T12 TO PELVIS AND THE SURGEON BELIEVED THE RIGHT L2 SCREW WAS APPROXIMATELY 2-3 MM MEDIAL FROM THE PLAN. THE SURGEON TOOK THE SCREW OUT AND REPLACED IT FREE HANDED. THEY WERE THEN ABLE TO CONTINUE ON WITH THE SURGERY. THE PATIENT REPORTED SOME NUMBNESS IN THEIR LEG. THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE. THE PATIENT WAS AFFECTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS A L4-S1 PERC WITH SCREWS BACKING UP AN OLIF. THEY FLIPPED PATIENT FROM LATERAL TO PRONE AND THEN DID A E3D SPIN. NO ISSUES WITH THE SPIN, HOWEVER THE IMAGE QUALITY WASN'T GREAT AND MADE IT DIFFICULT TO SEE ANATOMY. RUSSELL AND THE PA PLANNED THE INITIAL SCREW TRAJECTORIES AND THEN DR. WILLIAMS CAME OVER AND MADE FINAL ADJUSTMENTS TO THE PLAN. HE STARTED WITH L4-LEFT, THEN HE PLACE L4-RIGHT. HE THEN PLACED L5-RIGHT, HE NOTICED THAT THE MIS TOWER WAS SIGNIFICANTLY LOWER THAN HIS L4-RIGHT TOWER. HE OBTAINED A GREEN CHECK MARK FOR ALL OF HIS SCREWS AND DID NOT GIVE ANY EXTRA ROTATIONS AFTER THE GREEN CHECK MARK. WE WERE NOT SURE WHY THIS WAS THE CASE. BEFORE PROCEEDING, WE WENT AND LOOKED AT THE PLAN AND THE PLAN SHOWED THAT 4 AND 5 SHOULD HAVE HAD THE SAME HEIGHT AND DEPTH. ONCE ALL THE SCREWS WERE PLACED, WE TOOK CONFIRMATION SHOTS WITH THE C-ARM. DR. WILLIAMS THEN POINTED OUT TO US THAT THE L5-RIGHT SCREW WAS ABOUT A CM LOWER THAN L4. HE THEN BACKED OUT THE L5 SCREW TO BE MORE IN LINE WITH HIS L4 SCREW. HE PLACED 6 SCREWS IN TOTAL AND 5 OF THE 6 SEEMED TO BE AT THE APPROPRIATE HEIGHT/DEPTH. DR. WILLIAMS WANTS TO KNOW WHY THE L5-RIGHT SCREW WAS PLACED LOWER THAN WHAT HIS PLA

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 AFTER A SURGERY ON (B)(6) 2023 UTILIZING THE EXCELSUS GPS THE PATIENT EXPERIENCED EXTREME PAIN AND DECREASED MOVEMENT IN THEIR LEGS. ON (B)(6) 2023 MRI SCANS REVEALED A COMPRESSION FRACTURE OF T10. REVISION WAS PERFORMED URGENTLY TO DECOMPRESS THE SITE AND REVISE THE HARDWARE SURROUNDING IT.

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 SITE WERE UNABLE TO COMPLETE THE REGISTRATION OF THE PATIENT FROM L3 TO S1. THE SITE WERE WORKING WITH A PRE-OP CT SCAN AND PLACED TWO TITANIUM CAGES FROM L4 TO L5 AND L5 TO S1. THEY HAD ALSO PLACED A PELVIC BOLT IN S2. THE MANUFACTURER REPRESENTATIVE SAID THAT THE PELVIC BOLT WAS COVERING THE S1 BODY IN THE OBLIQUE SHOT, BUT DID NOT THINK THE INABILITY TO PERFORM THE REGISTRATION WAS DUE TO THE PELVIC BOLT, BUT THOUGHT THE TITANIUM CAGES MAY HAVE BEEN THE ROOT CAUSE OF THE ISSUE. THE GUIDANCE SYSTEM WAS ABORTED, AS THE SURGEON RESORTED TO THE NAVIGATION SYSTEM. THE DELAY WAS 1 HOUR. THE PATIENT'S BLOOD LOSS WAS INCREASED AND THE PATIENT NEEDED SEVERAL BLOOD TRANSFUSIONS BECAUSE OF THE DELAY. PATIENTS RECOVERY MAY BE AFFECTED, BUT THEIR OUTCOME WILL BE THE SAME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS DAMAGED AND THE COVER WAS TORN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE INSTRUMENT WAS COLLIDED WITH THE MONOPOLAR CURVED SCISSORS INSTRUMENT, AND THE PLASTIC WRIST COVER AND THE PLASTIC PART OF THE TIP WERE BROKEN AFTER THE COLLISION. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT¿S ANATOMY. POST-OPERATIVE TESTS (X-RAY AND ULTRASOUND) WERE PERFORMED. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS. THE PROCEDURE WAS DELAYED FOR TEN MINUTES. THE SYNCHROSEAL INSTRUMENT AND THE PLASTIC OVERMOLD WERE DISCARDED AND WILL NOT BE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6) REPORTED THAT THE PATIENT UNDERWENT TOTAL MESORECTAL EXCISION ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT COMPLAINED OF FEVER, GENERAL DISCOMFORT, AND WEAKNESS. A DIGITAL EXAMINATION CONFIRMED THAT THE ANASTOMOSIS WAS NORMAL. AS FEVER WAS 39.5 AND SUDDEN, IN ORDER TO BE SURE THAT THERE WAS NO ISCHEMIC CHANGES IN THE COLON WHICH WAS BROUGHT TO SMALL PELVIS FOR COLO-ANAL ANASTOMOSIS, FLEXIBLE PROCTOSCOPY WAS DONE. IT REVEALED NECROTIC DISTAL COLON (APPROX. 5-10 CM) ABOVE ANASTOMOSIS. AN URGENT LAPAROTOMY WAS PERFORMED: THE COLON WAS BROUGHT FROM SMALL PELVIS, RESECTED, AND TERMINAL COLOSTOMY WAS DONE SAME DAY. ANUS (VERY SHORT RECTAL STUMP) WAS CLOSED WITH PURSESTRING SUTURE. THE SURGICAL FOLLOW-UP WAS UNEVENTFUL, BUT DUE TO URINARY RETENTION ON (B)(6) 2023 AN EPICYSTOSTOMY WAS PERFORMED FOR A DATE OF RESOLUTION ON (B)(6) 2023. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THE EVENT OCCURRED ON (B)(6) -2023 AND ASENSUS SURGICAL WAS MADE AWARE ON 08-SEPTEMBER-2023.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETERAL REIMPLANTATION SURGICAL PROCEDURE THAT PATIENT SIDE MANIPULATOR (PSM) 3 WAS NOT ACCEPTING THE DRAPE. THE SITE TRIED RESEATING THE DRAPE MULTIPLE TIMES. A 30900 ERROR ALSO OCCURRED. THE SITE CHECKED TO ENSURE THAT THE DRAPE WAS EVEN, AND NO PART OF THE DRAPE WAS UNDERNEATH THE STERILE ADAPTOR. THE CUSTOMER RE-DRAPED THE SYSTEM, WITH NO CHANGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER EMERGENCY POWER OFF (EPO), AND POWER CYCLE THE SYSTEM, WITH NO CHANGE. THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE FROM THE SINGLE-PORT SYSTEM TO THEIR XI SYSTEM. THERE WERE NO REPORTS OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THERE WERE NO ERRORS OBSERVED BY THE CUSTOMER. THE DELAY WAS ROUGHLY ONE HOUR.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EGPS UNIT WILL NOT POWER ON. EITHER THE POWER CABLE OR WHERE IT CONNECTS TO THE UNIT IS DAMAGED. A CASE COULD NOT BE PERFORMED WITH THE ROBOT TODAY BECAUSE OF THE ISSUE. IT HAD TO BE COMPLETED UNDER 2D FLUORO WITHOUT THE EGPS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿LEARNING CURVE FOR SINGLE-PORT ROBOT-ASSISTED RECTAL CANCER SURGERY¿, THE FOLLOWING EVENTS WERE REPORTED. FROM APRIL 2019 TO OCTOBER 2019, 57 SINGLE-PORT ROBOTIC (SPR)-ASSISTED RECTAL CANCER SURGERIES PERFORMED BY ONE SURGEON WERE INCLUDED IN THE STUDY. A TOTAL OF 57 PATIENTS (34 MALES, 59.6%) WERE TREATED FOR RECTAL CANCER AND INCLUDED 34 LOW ANTERIOR RESECTION(LAR) (59.6%), 14 ULTRA-LAR (24.6%), 7 INTERSPHINCTERIC RESECTION (ISR) (12.3%), AND 2 APR (ABDOMINOPERINEAL RESECTION) (3.5%) CASES. AMONG THESE, 11 PATIENTS ADDITIONALLY UNDERWENT ROBOTIC TRANSANAL TOTAL MESORECTAL EXCISION (TATME). THE MEAN AGE OF THE PATIENTS WAS 57.4 ± 10.1 YEARS, THE MEAN BMI WAS 24.5 ± 3.5 KG/M2, AND THE MEDIAN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS (PS) CLASSIFICATION WAS II. THE MEAN VALUE OF TOTAL OPERATION TIME (OT) WAS 241.8 ± 91.7 MINUTES. THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS 158.4 ± 103.3ML. A TOTAL OF 23 COMPLICATIONS WERE IDENTIFIED IN THE PATIENTS WHO UNDERWENT SURGERY WHICH INCLUDES POSTOPERATIVE ILEUS, POSTOPERATIVE BLEEDING, CHYLOUS DRAIN COLOR CHANGE, AND URINARY RETENTIO

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 SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, A PNEUMOTHORAX AND PNEUMOMEDIASTINUM WERE NOTED POST-PROCEDURE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PNEUMOTHORAX AND PNEUMOMEDIASTINUM RESOLVED AND THE PATIENT WAS DISCHARGED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR INSERTED HIS LAST SCREW THEN CAPTURED FLUORO SHOTS. FLUORO AND STIMMING THE SCREW PROVED IT WAS INFERIOR OF THE PLANNED POSITION. THE DOCTOR REMOVED THE SCREW AND THEN RE-IMPLANTED IT WITH A JAMSHID-K-WIRE.

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: ROBOT CAMERA DISPLAYED HARDWARE BUMP PERFORMED MERGE VERIFIED ALL INSTRUMENTS INCLUDING EE. SUCCESSFUL MERGE, WHEN WE WENT TO PLACE IMPLANTS, SURGEON WAS UNABLE TO SELECT LEVEL AND GUIDE ROBOT TRAJECTORY. SURGEON ABORTED ROBOT PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE GEAR/CABLE MECHANISM OF THE FENESTRATED FORCE BIPOLAR BROKE WHILE GRASPING THE STOMACH. THE INSTRUMENT COULD NOT BE OPENED (WITH HELP OF INTUITIVE SUPPORT - WOULD NOT OPEN W/IRK) SO THE STOMACH WAS FORCIBLY REMOVED WHICH CAUSED A LARGE HOLE IN THE STOMACH. STOMACH REPAIRED IN 2 LAYERS, LEAK TEST ON EGD WAS NEGATIVE. UNABLE TO COMPLETE THE PARAOESOPHAGEAL HERNIA REPAIR AS PLANNED - PERFORMED GASTROPEXY INSTEAD.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A GOOD MERGE WITH 0 SHIFTS. WHEN LANDING END EFFECTOR ON TRAJECTORY THE INSTRUMENTS ON THE SCREEN WERE NOT MATCHING WHAT THE WE WERE SEEING LIVE ON THE PATIENT. REIMAGED THE PATIENT AND STILL HAD NO SHIFT. NAV STILL LOOKED OFF AT THE TOP OF THE CONSTRUCT BUT DEAD ON LOWER SCREWS. STILL MISSED OUR L5 RIGHT SCREW. SENDING LOGS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE LEFT EYE IN THE SURGEON SIDE CART (SSC) WAS NOT WORKING. THE TSE WAS UNABLE TO VIEW THE LIVE LOGS. THE TSE WALKED THE CUSTOMER THROUGH A SYSTEM POWER CYCLE AND A HARD POWER CYCLE OF THE SSC, BUT THE LEFT EYE IMAGE WAS STILL NOT PRESENT. THE TE HAD THE CUSTOMER VERIFY THE FIBER CABLING HAD BLUE LED AT BOTH ENDS AND IT WAS BLUE. THE CUSTOMER WAS UNSURE HOW THEY WOULD PROCEED WITH THE CASE AND WERE ACTIVELY SEARCHING FOR ANOTHER SYSTEM TO UTILIZE. THE CALL ENDED AND THE TSE WAS UNABLE TO TROUBLESHOOT FURTHER. THE PROCEDURE WAS COMPLETION UNKNOWN WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE OR DIRECTOR INFORMED THERE WAS NO HARM TO THE PATIENT IDENTIFIED EXCEPT PROLONGED ANESTHESIA EXPOSURE SINCE WE HAD TO CONVERT TO MULTIPORT. THE CASE WAS CONVERTED TO MULTIPORT FROM A SINGLE PORT SYSTEM. THE CUSTOMER WILL NOT BE DISCLOSING ANY PATIENT INFORMATION.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A GOOD MERGE WITH 0 SHIFTS. WHEN LANDING END EFFECTOR ON TRAJECTORY THE INSTRUMENTS ON THE SCREEN WERE NOT MATCHING WHAT THE WE WERE SEEING LIVE ON THE PATIENT. REIMAGED THE PATIENT AND STILL HAD NO SHIFT. NAV STILL LOOKED OFF AT THE TOP OF THE CONSTRUCT BUT DEAD ON LOWER SCREWS. STILL MISSED OUR L5 RIGHT SCREW. SENDING LOGS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿A SINGLE-CENTER EXPERIENCE OF OVER 300 CASES OF SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY COMPARING THE DA VINCI SP WITH THE SI/XI SYSTEMS¿, THE FOLLOWING EVENTS WERE REPORTED. A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT SINGLE-INCISION ROBOTIC CHOLECYSTECTOMY BETWEEN (B)(6) 2014 AND (B)(6) 2021 AT A SINGLE CENTER WERE INCLUDED IN THE STUDY. IN TOTAL, 334 PATIENTS UNDERWENT SINGLE-INCISION ROBOTIC CHOLECYSTECTOMIES, WITH 118 PATIENTS USING SI/XI SYSTEM AND 216 PATIENTS USING SINGLE PORT (SP). OF THE 216 PATIENTS THAT UNDERWENT SP SURGERIES, TWO PATIENTS IN THE SP GROUP CONVERTED TO MULTIPORT LAPAROSCOPIC SURGERIES. THE CONVERSION WAS DUE TO ONE OF THE PATIENTS HAD ACUTE CHOLECYSTITIS AND THE OTHER HAD SEVERE ADHESIONS FROM PREVIOUS UPPER ABDOMINAL SURGERY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, SUCH AS MASSIVE BLEEDING OR BILE DUCT INJURIES. SEVEN PATIENTS WERE OBSERVED WITH ACUTE INFLAMMATION INTRA-OPERATIVELY. THE ESTIMATED BLOOD LOSS FOR ALL PATIENTS WAS < 50ML, EXCEPT FOR THE CASES THAT REQUIRED CONVERSION TO LAPAROSCOPIC SURGERIES. THE RATE OF POST-OPERATIVE COMPLICATIONS IN S

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IDENTIFIED AS L1-L3 BY SURGEON, REP, AND CSR. CENTROIDS WERE PLACED ON THE L1-L3 LEVELS AND A MERGE WAS RUN. THE SURGEON, REP, AND CSR REVIEWED THE MERGE AND VERIFIED THE LEVELS TOGETHER. FOLLOWING PLACEMENT OF SCREWS AT L1, SURGEON NOTED NAVIGATION WAS NO LONGER ACCURATE. WE REIMAGED THE PATIENT BEFORE PLACING SCREWS AT L3. FLUORO WAS USED TO CONFIRM SCREW PLACEMENT, BUT IT WAS NOTED THAT THE RIGHT L3 SCREW WAS MEDIAL TO WHAT WAS PLAN. THE SCREW STIMULATED AT 9MA, PER NEUROMONITORING TECH. THE SURGEON REMOVED THE SCREW AND DECIDED TO REPLACE IT FREEHAND USING FLUORO ASSISTANCE. ALL SCREW PLACEMENT WAS CONFIRMED WITH FINAL FLUORO IMAGES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER THE SCREWS WERE PLACED, ALL OF THE LUMBAR SCREWS AND S2AIS LOOKED GOOD ON THE IMAGES, BUT WE NOTICED THAT ALL OUR SILOK SCREWS LOOKED LIKE THEY WERE BURIED TOO DEEP.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T. AKAZAWA, Y. TORII, J. UENO ET AL., SAFETY OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY: EXPERIENCE FROM THE INITIAL 125 CASES, JOURNAL OF ORTHOPAEDIC SCIENCE, HTTPS://DOI.ORG/10.1016/J.JOS.2023.06.003 SUMMARY: THE PRESENT STUDY AIMED TO EVALUATE THE SAFETY OF ROBOT-ASSISTED SCREW PLACEMENT IN 125 CASES AFTER INTRODUCING A SPINAL ROBOTICS SYSTEM AND TO IDENTIFY THE SITUATIONS WHERE DEVIATION WAS LIKELY TO OCCUR. THE SUBJECTS WERE 125 CONSECUTIVE PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED SCREW PLACEMENT USING A SPINAL ROBOTICS SYSTEM (MAZOR X STEALTH EDITION, MEDTRONIC) FROM APRIL 2021 TO JANUARY 2023. THE 1048 SCREWS PLACED WITH ROBOTIC ASSISTANCE WERE EVALUATED. WE INVESTIGATED INTRAOPERATIVE ADVERSE EVENTS OF THE ROBOTICS SYSTEM AND COMPLICATIONS OCCURRING WITHIN 30 DAYS AFTER SURGERY. WE EVALUATED SCREW ACCURACY AND DEVIATION AND COMPARED THEM FOR VERTEBRAL LEVELS, SCREW INSERTION METHODS (OPEN TRADITIONAL PEDICLE SCREW [OPEN-PS], CORTICAL BONE TRAJECTORY SCREW [CBT], PERCUTANEOUS PEDICLE SCREW [PPS], AND S2 ALAR ILIAC SCREW [S2AIS]), DIAGNOSIS, AND PHASES OF SURGICAL CASES. THE DEVIATION RATE OF ROBOTIC-ASSISTED SCREW PLACEMENT FOR SPINE SURGERY WAS 2.2%. COMPLICATIONS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS AN INTRAOP (O-ARM) L4-L5 TLIF EXTENSION OF EXISTING L5-S1 TLIF WITH REMOVAL OF L5-S1 SCREWS AND RODS. INTRAOP WITH CREO 5.5 SCREWS. FIRST DR (B)(6) OPENED UP THE PATIENT AND REMOVED THE EXISTING MATERIAL, THEN PLACED DRB AND SM ON PSIS. SM WAS ACTIVATED, SCOUT SHOTS WERE TAKEN, APNEA WAS INITIATED, SNAPSHOT AND SCAN WERE TAKEN. DURING SCAN TRANSFER, ANEA WAS APPLIED ONCE MORE. NOTHING WAS MOVED BEFORE THE SCAN WAS AUTO REGISTERED. DRB SHIFT WAS SHOWN WHILE TRANSLATING THE OR TABLE OUT OF THE O-ARM LUMEN BUT DISAPPEARED ONCE PATIENT WAS FULLY BACKED OUT AND SM TURNED GREEN. SCREW PLANNING WAS DONE (PEDICULE SCREWS). WE NOTICED THAT TWO "TRAJECTORIES" WERE HIGHLIGHTED IN THE 3D VIEW. WHEN MOVING THE ROBOT TO THE OR TABLE, THE CAMERA WENT DEAD. THE CAMERA COULD NOT SEE ANYTHING ANYMORE (NO DRB, NO EE, NO INSTRUMENTS) AND THE ARM MOVEMENT WAS FROZEN. THE ARM COULD NOT BE MOVED, NEITHER BY THE BUTTONS ON THE CP, NEITHER BY THE FOOTSWITCH OR BRACELET. I SWITCHED TO CRANIAL AND BACK, WHICH UNLOCKED THE CAMERA AND THE ARM MOVEMENT. WHEN DRILLING FIRST SCREW DEFLECTION WAS NOTICED, BUT DRILLED TRAJECTORY WAS COMPLETELY LATERAL OF THE PLANNED ONE (VERIFIED WITH FEELER). SURGEON

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE DOING AN INTRAOPERATIVE WORKFLOW, WERE ABLE TO SUCCESSFULLY DO A SPIN BUT NAVIGATION WAS OFF BY APPROXIMATELY 5 MM IN THE SUPERIOR DIRECTION AND A SCREW WAS MISPLACED. THEY THEN DECIDED TO RESIGN BUT UPON REBOOT E3D REQUIRED A FULL REHOMING. AFTER A FULL REHOMING THEY DID ANOTHER SPIN AND NAVIGATION WAS ACCURATE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FUSES NEED REPLACING FOR EXCELSIUS GPS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER MERGING THE PREOP CT TO THE FLUOR SHOTS, WE ATTACHED THE EE TO THE ARM AND ATTEMPTED TO VERIFY IT BEFORE STABILIZING THE ROBOT FOR TRAJECTORY. ALTHOUGH THE EE WASN'T SEEN ON SCREEN, IT STILL VERIFIED WHEN THE TECH PLACED AN INSTRUMENT INTO IT. ON THE NAVIGATION PAGE THE CAMERA WAS ONLY SEEING THE DRB AND SURVEILLANCE BUT NOT THE EE. TRIED TAKING IT OFF/PUTTING IT BACK ON, RESETTING THE SOFTWARE, SWITCHING BACK AND FORTH FROM CRANIAL, AND RESTARTING THE SYSTEM. ALSO TRIED A DIFFERENT EE. SURGEON DECIDED TO DO THE XLIF FIRST, AND WHILE HE WAS PERFORMING THE XLIF WE WERE ABLE TO GAIN VISUALIZATION OF THE EE WITH THE ROBOT PULLED BACK/AWAY FROM THE PATIENT. POST XLIF, WE RE-MERGED WITH "ADDED HARDWARE" AND BROUGHT THE ROBOT BACK IN. THIS TIME THE EE WAS GOING IN AND OUT OF VISUAL RANGE. THE EE WOULD TRAVEL TOWARDS A TRAJECTORY AND STOP SHORT SHOWING A CYCLE OF BLANK/GREEN/YELLOW. TRIED REPOSITIONING THE DRB AND REMERGING WITH A DIFFERENT EE. SURGEON DECIDED TO DO THE SCREWS FREEHAND WITH FLUORO.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FRAGMENTS FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGES WERE OBSERVED. THE INSTRUMENT WAS IN USE FOR 15 MINUTES WHEN THE ISSUE HAPPENED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE FRAGMENT WAS JUST ONE BROKEN PIECE WHICH WAS REMOVED SUCCESSFULLY. NO ADDITIONAL PROCEDURES WERE DONE. NO POST OPERATIVE TESTS WERE DONE. A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR HARM. THE PATIENT DID NOT RETURN TO THE HOSPITAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) ROBOT CASES. 2 DIFFERENT ROBOTS. BOTH PRE-OP CT CASES. T10-ILIUM. WE ARE PUTTING X2 SI-LOK SELECT SCREWS AT THE BOTTOM OF THE CONSTRUCT IN THE BEDROCK TRAJECTORY. FIRST CASE WAS ON 5/16. WE SELECTED LEFT SIDE FIRST. DRILL WAS ACCURATE. AND WE PROCEEDED TO PUT THE LEFT SCREW IN UNTIL WE GOT A CHECK MARK. DR. (B)(6) FELT SOMETHING WAS WRONG. RIGHT SIDE WENT FINE.UPON X-RAY THE LEFT SIDE WAS DEEP ABOUT AN INCH. PUT THE NAV DRIVER BACK ON TO BACK UP SCREW AND IT NOW SHOWED AN INCH DEEP AS IT DID NOT BEFORE. SECOND CASE 5/31 SAME EXACT THING HAPPENED HOWEVER WE CAUGHT IT BEFORE PROCEEDING TO PUT IN THE SCREW. BOTH INSTANCES THE RIGHT-SIDE NAV WAS ON. IT WAS ONLY LEFT SIDE THAT WE SELECTED FIRST. PLEASE CALL ME FOR MORE DETAILS ON HOW WE TROUBLESHOOTED IT AND ON MY THEORY OF WHAT HAPPENED. ALL CASES AND LOGS ARE UPLOADED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER IMPLANTING THE SCREW, THE DEFLECTION METER WAS TRIGGERED SHOWING THE SCREW INFERIOR OF THE INTENDED PLAN. UPON MOVING TO L5L ANOTHER LM CHECK WAS SUGGESTED AND NAVIGATION AT THIS POINT BUT STILL LOOKED ACCURATE AS THE CROSSHAIRS WERE INTERSECTING BONE ON AXIAL AND SAGITTAL VIEWS. AFTER USING THE HS DRILL AND PILOT DRILL THE DOCTOR WAS CONCERNED. I HAD NOTICED THE SOUND OF THE DRILLS GOING THROUGH THE LAYERS OF CORTICAL BONE WASN'T REFLECTING WHAT WE WERE SEEING ON THE NAVIGATION. THE DOCTOR IMMEDIATELY CALLED FOR X-RAY AND PUT THE VERIFICATION PROBE INTO THE HOLE HE PREPPED FOR L5L. THE C-ARM WAS BROUGHT IN AND AP/LAT SHOTS SHOWED EACH SIDE WAS SYMMETRICAL BUT 5MM INFERIOR OF THE PEDICLE. THE L5R SCREW WAS REMOVED. WE BAILED TO PRE-OP CT WORKFLOW WITH E3D.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SCREW WAS MISSED SUPERIORLY AT L5R. THIS WAS THE SECOND SCREW OF THE CONSTRUCT, AND THE OTHER SCREWS WERE PROVEN TO HAVE CORRECT PLACEMENT WITH FLUORO SHOTS. THERE WAS AN AIR BUBBLE IN THE PEDICLE, AND SOME DEFLECTION WAS SHOWN. A CHECKMARK WAS GIVEN BY THE SOFTWARE WHEN THE SCREW WAS PLACED INITIALLY. FLUORO SHOTS WERE TAKEN AFTER ALL 6 TRAJECTORIES WERE COMPLETED, AND THE L5R SCREW WAS PULLED OUT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT SCREWS PLACED LATERALLY AND INFERIORLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT HAD BOTH "RINGS" FALL OFF. ONE RING WAS RECOVERED, THE SECOND ONE WAS LOST IN SITU. WHEN PULLING OUT THE INSTRUMENT, THE METAL CABLE WAS OBSERVED AT THE DISTAL END OF THE SHAFT. IT WAS REPORTED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS UNKNOWN IF RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND LESS THAN A 15-MINUTE DISPLAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED ADDITIONAL INFORMATION: THE "RING" WAS DESCRIBED AS THE "PROTECTIVE SCREW" AT THE DISTAL END. ADDITIONALLY, AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS RESECTING A LARGE-VOLUME MALIGNANT TUMOR IN THE AREA OF THE MIDDLE PART OF THE MESO ROOT. THE SYNCHROSEAL INSTRUMENT WAS USED FOR DISSECTION AND TO CUT/SEAL SMALLER BLOOD VESSELS. THE FRAGMENT/PART WAS DESCRIBED AS BEING SIMILAR TO A WASHER AND WAS DISCOVERED LYING RETROPERITONEALLY. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO KNOWN COLLISIONS DURING THE PROCEDURE. THE CUSTOMER FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AND CANNULA DAMAGE WAS OBSERVED. A POST-OPERATIVE X-RA

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS A L3-S2 PSF WITH EGPS AND E3D AT SARASOTA MEMORIAL WITH DR. (B)(6). DRB AND SM WERE PLACED IN CONTRALATERAL PSIS. WE RECEIVED AN ERROR STATING THAT THE DRB HINGE WAS TOO CLOSE TO THE SM (THIS ACCOUNT GETS THIS WARNING OFTEN). THIS WAS BYPASSED DUE TO THEM BEING ADEQUATE DISTANCE AWAY. SCAN WAS OBTAINED AND TRANSFERRED TO THE ROBOT WITHOUT ANY ISSUES. SCREWS WERE PLANNED BY REP (B)(6) AND DR. (B)(6). ROBOT WAS BROUGHT INTO THE FIELD. DR. (B)(6) STARTED AND L3 AND PLACED SCREWS DOWN TO S2. NAVIGATION LOOKED INTACT THROUGHOUT ENTIRE CASE. DRB WAS NOT HIT AND OFFSET WAS CONTINUOUSLY LOW. DEFLECTION STAYED IN THE YELLOW TO LOW RED RANGE DURING THE LOWER LEVELS DUE TO PATIENTS HARD SCLEROTIC BONE. DR. (B)(6) USED THE HS BURR, DRILL, BALL TIP PROBE, TAP AND DRIVER. PT HAD PREVIOUS L4-5 INTERSPINOUS PROCESS FIXATION DEVICE PRESENT THROUGHOUT THE SPIN AND SCREWS. AFTER SCREWS WERE FINISHED ROBOT WAS TAKEN OUT OF THE ROOM AND DR. (B)(6) PROCEEDED WITH THE DECOMPRESSION AND INTERBODY. FINAL SHOTS WERE TAKEN, AND IT WAS NOTED THAT RL4 WAS IN THE SUPERIOR DISC SPACE AND LL4 WAS BREACHED CAUDALLY PER DR. (B)(6). SCREWS WERE REMOVED AND NOT REPLACED. ALL OTHER SCREWS WERE IN THEIR PLANNE

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 NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS PRE-OP CASE, T6-T10. AFTER SUCCESSFUL REGISTRATION, WE GOT ALL TRAJECTORIES IN GREEN ON THE NAVIGATION PAGE BUT THE ROBOT ARM MOVED ONLY TO T6-L. AS THE SURGEON PRESSED THE PEDAL, THE ROBOT ARM WITH EE DIDN'T MOVE TO ANOTHER TRAJECTORY, DESPITE ALL BEING GREEN. THE MESSAGE THAT WE GOT WAS-TRAJECTORY OUT OF RANGE(IN YELLOW). WE MOVED THE ROBOT MULTIPLE TIMES, BUT THE ARM MOVED ONLY TO ONE TRAJECTORY-T6-L EVERY TIME. WE DID A SOFTWARE RESET, NEW REGISTRATION, ATTACHED AND DETACHED THE EE, AND HARD SHUT DOWN, BUT IT DIDN'T HELP. THE CASE WAS ACCOMPLISHED TRADITIONALLY WITHOUT THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS AN EGPS CRANIAL BIOPSY PROCEDURE USING FLUORO REGISTRATION WORKFLOW ON SOFTWARE VERSION 20211.2R2P2. CASE WAS ABORTED DUE TO INABILITY TO OBTAIN AN ACCEPTABLE MERGE DURING PATIENT REGISTRATION. REQUESTING SOFTWARE INVESTIGATION TO DETERMINE WHAT WAS THE CAUSE OF THE INACCURATE MERGE ATTEMPTS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RIFAI (DISTRIBUTER REP) INFORMED THAT ONE CASE OF L4-L5 MIS FIXATION-INTRAOP (ALIF FIRST) WORKFLOW WAS PLANNED ON (B)(6) 2023. END EFFECTOR WAS VERIFIED WITHOUT ANY ISSUE, BUT THE EE WAS NOT GETTING DETECTED DURING NAVIGATION. TRIED TO ADJUST THE CAMERA BUT STILL NO DETECTION AND EE SYMBOL ON THE SCREEN WAS RED. FINALLY, THEY HAVE REPLACED THE EE WITH ANOTHER EE AND IT WORKED. THEY WILL UPDATE US LATER FOR THE STATUS OF FIRST EE. AFTER PLACEMENT OF ALL THE SCREWS IT HAS BEEN OBSERVED IN THE POST-OP SCAN THAT THE L4-R WAS SHIFTED LATERALLY AND L5-L WAS SHIFTED CRANIALLY FROM THE ORIGINAL PLAN. TWO SCREWS WERE REPOSITIONED MANUALLY.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF INSIDE THE PATIENT WHILE IN USE. THE INSTRUMENT FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RIFAI (DISTRIBUTER REP) INFORMED THAT ONE CASE OF FRACTURE AT T7 WAS PLANNED WITH TWO INTRAOP WORKFLOW. FIRST INTRAOP WAS DONE FROM T5-T9 AND EVERYTHING WAS LOOKING GOOD TILL THE PLACEMENT OF LAST SCREW AT T9-L. SECOND INTRAOP WORKFLOW WAS DONE FROM T11-L3. IT WAS OBSERVED IN THE POST-OP SCAN THAT SCREWS AT T8 & T9 WERE SHIFTED TOWARDS RIGHT SIDE. T8-T9 LEFT SCREWS WERE ALMOST TOUCHING THE CANAL. FINALLY SCREWS AT T8-T9 WERE RE-POSITIONED MANUALLY.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

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: DIAGNOSTIC OUTCOMES OF ROBOTIC-ASSISTED BRONCHOSCOPY FOR PULMONARY LESIONS IN A REAL-WORLD MULTICENTER COMMUNITY SETTING. AUTHOR(S): FAISAL KHAN, JOSEPH SEAMAN, TINA D. HUNTER, DIOGO RIBEIRO , BALAJI LAXMANAN , IFTEKHAR KALSEKAR AND GUSTAVO CUMBO NACHELI. CITATION: BMC PULMONARY MEDICINE. HTTPS://DOI.ORG/10.1186/S12890-023-02465-W. FIFTEEN PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND FOUR PATIENTS REPORTED BLEEDING. NO DEVICE ISSUES WERE REPORTED.