ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE PLACED QUATTRO SPIKE IN RIGHT PSIS AND SURVEILLANCE MARKER IS LEFT PSIS. WE TOOK X-RAYS FOR THE MERGE, AND ALL CONFIRMED L4 AND L5 VERTEBRAL BODIES. THE MERGE WAS SUCCESSFUL, AND X RAY CAME OUT. AT THIS POINT, THE REP HAD NOTICED THAT THE DRB ON THE LEFT WAS CLOSE TO PATIENT AND ASKED IF IT HAD BEEN LIKE THAT. I ASKED THE SURGEON IF THERE WAS A GAP, SURGEON CONFIRMED THAT THERE WAS. ROBOT WAS BROUGHT IN, AND STABILIZERS WERE PLACED. SURGEON MOVED FORWARD WITH PLACING LEFT L4, INSTRUMENTS DIDN'T LOOK RIGHT ON NAVIGATION, BUT SURGEON FELT FINE. WE DID L5 AND SAW SAME NAVIGATION ISSUE AFTER PLACING SCREW WE DECIDED TO TAKE A X RAY TO CONFIRM AND NOTICED WE WERE OFF. SURGEON THEN HAD ROBOT TAKEN OUT AND OPENED PATIENT UP. SCREWS REMOVED AND HE FINISHED THE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT FRAGMENT WAS RETRIEVED BY THE ASSISTANT USING AN ENDOSCOPE. ALL FRAGMENTS WERE CONFIRMED TO HAVE BEEN RETRIEVED BY THE ASSISTANT AND NURSE. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED AND NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON BELIEVES THE CAUSE OF THE BREAK WAS AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE INSTRUMENT WAS USED FOR AN HOUR AND A HALF PRIOR TO THE BREAK. THE INSTRUMENT WAS BEING USED FOR GRASPING WHEN IT BROKE. THERE WAS NO FUNCTIONALITY ISSUE AND NO INSTRUMENT COLLISION PRIOR TO THE BREAKAGE. THE INSTRUMENT WAS ALSO NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS SOME RESISTANCE WHEN REMOVING THE INSTRUMENT THROUGH THE CANNULA, BUT NO DAMAGE TO THE CANNULA, AND NO FURTHER

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PORTION OF THE BLUE PART OF THE CANNULA SEAL BROKE OFF INSIDE THE PATIENT WHEN A REDUCER WAS INSERTED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE TROCAR APPEARED NORMAL. A PIECE OF THE CANNULA SEAL WAS IDENTIFIED PRIOR TO THE CONCLUSION OF THE CASE, INCIDENTALLY. THE SURGEON BELIEVES THE REDUCER PLACED THROUGH THE 12MM BROKE OFF A PIECE OF THE CANNULA SEAL WHICH FELL INSIDE THE PATIENT'S ABDOMEN. THE TROCAR WAS USED THE ENTIRE CASE, BUT AIRSEAL (A 3RD PARTY MANUFACTURER PRODUCT) WOULD NOT WORK CORRECTLY ON THE AFFECTED 12MM TROCAR. THERE WERE NO DEVICE COLLISIONS AND NO INSTRUMENTS WERE REMOVED PRIOR TO BREAKAGE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT WAS REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT THROUGH THE CANNULA. THE FRAGMENT WAS INSPECTED AND IDENTIFIED AS THE ONLY BRO

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROUTINE CASE, REGISTRATION WAS COMPLETED AND FIRST 2 SCREWS WERE PLACED SUCCESSFULLY. THIRD TRAJECTORY WAS ACTIVATED. SYSTEM GAVE ERROR "FOOTPEDAL ENABLED ERROR". USER THEN TRIED TO ACTIVATE SURGEON BRACELET AND THAT DID NOT WORK AT ALL. THAT IS WHEN THE USER DISCOVERED THE SYSTEM DID NOT HAVE ANY MOVEMENT AND THE FIRST SHUT DOWN WAS COMPLETED. THE USER LOGGED IN TOO QUICK WHEN MOTION WAS STILL BE CHECK SIGNIFIED BY BLUE INFORMATION RING. IT WAS ATTEMPTED TO CALIBRATE LOAD CELL WHICH DID NOT WORK. USER THEN PLACED REST OF SCREWS FREE HAND. SYSTEM WAS PULLED OUT OF THE FIELD AFTER THE PROCEDURE. FOOT PEDAL WAS RE-ENGAGED INTO THE PORT AND A LOAD CELL CALIBRATION WAS COMPLETED. THEY PULLED HTE SYSTEM OUT AND RESTARTED AGAIN AND MOTION WAS RESTORED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE ASSISTANT OBSERVED ON THE MONITOR THAT PART OF THE JAW OF THE HARMONIC ACE INSTRUMENT HAD BECOME DETACHED AND FALLEN INTO THE PATIENT'S ABDOMINAL CAVITY. THE FRAGMENT WAS PROMPTLY FOUND AND REMOVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO APPARENT DAMAGE. THE TASK PERFORMED WHEN THE FRAGMENT FELL WAS DISSECTING. THE SURGEON DID NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK OR WHAT CAUSED THE FRAGMENT TO FALL. THE INSTRUMENT WAS IN USE FOR 3 HOURS PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE PROCEDURE. THE FRAGMENT FELL DURING A TIP COLLISION. THE FRAGMENT WAS RETRIEVED WITH ANOTHER ROBOTIC GRIPPER RIGHT AFTER THE EVENT. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED BY VIEWING AND CONFIRMING WITH THE TEAM. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGME

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 WAS NOTED. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT.

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 DAVINCI ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE END OF THE SYNCHRO SEAL CAME DETACHED. THE PIECE OF SHEATH WAS RETRIEVED, THEREFORE NO HARM TO THE PATIENTS. THE SURGEON FELT THIS OCCURRED DUE TO CLASHING OF INSTRUMENTS. 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 WITH NO REPORTED DAMAGE. THE EVENT OCCURRED WHILE GRASPING AND CAUTERIZING WHEN THE ALLEGED INSTRUMENT WAS TOO CLOSE TO ANOTHER INSTRUMENT LEADING TO CLASHING. THE CLASH WAS DUE TO NARROW PELVIS. PER SURGEON, THE PORTS SHOULD HAVE BEEN PLACED HIGHER UP. THERE WAS NO ISSUE WITH INSTRUMENT FUNCTIONING BEFORE THE OCCURRENCE OF EVENT. THERE WAS NO RESISTANCE WHILE REMOVING THE INSTRUMENT FROM SURGICAL FIELD. THE FALLEN FRAGMENT WAS REMOVED THROUGH THE PORT WITH GRASPER. IT WAS SINGLE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH BACK-UP INSTRUMENT WITH NO PATIENT HARM. THERE IS NO REPORT OF POST SURGICAL COMPLICATIONS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN EGPS WITH E3D SINGLE LEVEL L5-S1 PERC CASE, THE TWO L5 SCREWS WERE PLACED SUPERIOR TO THE PLAN. IT IS ASSUMED THAT THE DRB WAS MOVED DURING THE CASE AND DISCOVERED THAT THE SURVEILLANCE WAS NOT SET. DURING SCREW PLACEMENT, NOTHING LOOKED UNUSUAL - DOCKING THE HIGH-SPEED BUR ON THE BONE DIDN'T SHOW THE BUR HIGH OR INTO THE BONE AS ONE WOULD EXPECT WITH A DRB SHIFT. THE SCREWS ALL STIMULATED AT 20MA EXCEPT THE RIGHT S1 WHICH WAS 10MA WHICH PROMPTED A VERIFICATION SPIN WITH THE E3D. THE L5 SCREWS AND THE RIGHT L1 WERE REMOVED AND A SECOND E3D SPIN WAS DONE. THE SCREWS WERE THEN PLACED WITH NO FURTHER DIFFICULTY. THE CASE LOG WILL BE FORWARDED.

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

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS AN L2-4 LLIF WITH POSTERIOR FIXATION USING CREO MIS AND PRE-OP CT WORKFLOW USING EGPS. THE CT SCAN APPEARED TO BE TO PROTOCOL BUT UPON MERGING THE AP AND LATERAL VIEWS APPEARED OBLIQUE AND A SUCCESSFUL MERGE COULD NOT BE OBTAINED EVEN WITH TRUE SHOTS. I AM ATTACHING CASE LOGS AS WELL AS A ZIPPED FOLDER OF THE CT SCAN SO INR APPLICATIONS MAY REVIEW THIS SCAN FOR DATA. IT CAME TO MY ATTENTION THAT THE KERNEL VALUE OF THE CT WAS B70 AND THIS IS NOT IDEAL FOR OUR PROTOCOL. THE SCANNER WAS A SIEMENS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SURGERY WAS CONVERTED TO A LAPAROTOMY PROCEDURE AFTER THE SURGEON FOUND IT DIFFICULT TO IDENTIFY THE INCISION LINE OF THE TISSUE CONTAINING CANCER. THE PATIENT WAS UNDERGOING CHEMOTHERAPY AND HAD SEVERE LYMPH NODE EDEMA. THE SURGICAL FIELD WAS EXTREMELY WET DUE TO CHEMOTHERAPY, AND THE IDENTIFICATION OF THE CUTTING LINE WAS DIFFICULT. THE DOCTOR COMMENTED THAT LAPAROTOMY WAS A BETTER OPTION TO IDENTIFY THE INCISION LINE THAN CONTINUING TO USE DA VINCI SYSTEM. THERE WAS NO ISSUE WITH THE DA VINCI SYSTEM, AND THE CONVERSION WAS DONE AT THE DOCTOR'S DISCRETION. THE HOSPITAL CONFIRMED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L5-RT SCREW WE ACTUALLY HAD SPACE FOR A 5.5 SCREW RUNNING MEDIAL TO THE OLD SCREW AND TRIED THIS. THIS IS THE SCREW THAT ULTIMATELY LOOKED TO MEDIAL ON FLUORO AND WHEN WE DECOMPRESSED, WE COULD SEE 6 THREADS OF THE SCREW WERE MEDIAL TO THE PEDICLE WITH HALF THE SCREW EXPOSED.

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 ON AN ONLINE NEWS ARTICLE THAT AFTER A PATIENT UNDERWENT A ROBOTIC ASSISTED OVARIAN CYSTECTOMY FOR HER OVARIAN TERATOMA, THE PATIENT EXPERIENCED HIGH FEVER AND ABDOMINAL PAIN. THE PATIENT WAS FOUND WITH SMALL INTESTINE PERFORATION. FOLLOW-UP HAS BEEN ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION, BUT THERE'S CURRENTLY NO INFORMATION ABOUT THE PROCEDURE DATE, NOR THE MEDICAL INTERVENTION THAT WAS PERFORMED TO ADDRESS THE COMPLICATION.

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 A SYSTEM FAULT OCCURRED DURING SETUP FOR A MONARCH BRONCHOSCOPY. THE PHYSICIAN ELECTED TO NOT START THE DIAGNOSTIC PROCEDURE AND TO RESCHEDULE THE PROCEDURE FOR ANOTHER DAY. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

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 WHICH COMPARED INTRA-ABDOMINAL INFECTIOUS COMPLICATIONS OF ROBOTIC ASSISTED GASTRECTOMY SURGICAL PROCEDURES WITH LAPAROSCOPIC GASTRECTOMY SURGICAL PROCEDURES, THE FOLLOWING WAS IDENTIFIED: THIS RETROSPECTIVE, SINGLE-INSTITUTION STUDY AIMED TO ASSESS WHETHER ROBOTIC SURGERY (RG) OFFERS CLINICAL BENEFITS OVER LAPAROSCOPIC SURGERY (LG) FOR OBESE PATIENTS, LEVERAGING THE ROBOT¿S MECHANICAL ADVANTAGES. THE AUTHORS COMPARED SHORT-TERM OUTCOMES BETWEEN RG AND LG FOR PATIENTS WITH AND WITHOUT VISCERAL OBESITY. IN THE WHOLE COHORT, THE OVERALL COMPLICATION RATE WAS 13.0% FOR THE ROBOTIC GROUP, WHILE IN THE MATCHED COHORT, THE COMPLICATION RATE WAS HIGHER FOR RG. HOWEVER, THE INCIDENCE OF SEVERE COMPLICATIONS (CLAVIEN-DINDO GRADE III OR HIGHER) WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN RG AND LG IN EITHER COHORT. INTRA-ABDOMINAL INFECTIOUS COMPLICATIONS (IAICS) SUCH AS PANCREATIC FISTULA, ANASTOMOTIC LEAKAGE, AND INTRA-ABDOMINAL ABSCESSES WERE IDENTIFIED, WITH VISCERAL OBESITY BEING A SIGNIFICANT RISK FACTOR. ALTHOUGH THE ROBOTIC SYSTEM DID NOT DEMONSTRATE A CLEAR ASSOCIATION WITH INCREASED SPECIFIC COMPLICATIONS COMPARED TO LG, THE OVERALL COMPLICATION RA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE FAILED TO BE RECOGNIZED. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE WITH NO FURTHER ISSUES REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A FRAGMENT OF THE HARMONIC ACE FELL INSIDE OF THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THERE WERE NO POST-OPERATIVE TESTS PERFORMED. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE OF THE INSTRUMENT THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO ADDITIONAL DAMAGE TO THE INSTRUMENT. THERE WAS NO INJURY TO THE PATIENT.

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 24-JAN-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5150169 STATING: THE REPORTED EVENT WAS A POSTOPERATIVE DUODENAL SEGMENT STAPLE LINE LEAK, WHICH REQUIRED A SECOND OPERATION 20 DAYS AFTER THE INITIAL ROBOTIC-ASSISTED PROCEDURE. THE AREA OF THE LEAK WAS STAPLED VIA THE USE OF A COVIDIEN STAPLER.

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SYSTEM FAULTS OCCURRED DURING SETUP FOR A MONARCH BRONCHOSCOPY. THE PHYSICIAN ELECTED TO NOT START THE DIAGNOSTIC PROCEDURE. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MERGED CT WITH FLAT PANEL. CENTROID PLACEMENT SEEMED EXTRA OFF IN LATERAL VIEW EVEN MORE THAN USUAL. PHYSICIAN STATED THAT SOMETHING FELT OFF FROM FIRST SCREW. THROUGH 7 SCREWS PLACED, SURGEON X-RAYED AND NOTICED MULTIPLE SCREWS WERE BREACHED. NO ALARMS FROM SURVEILLANCE UNTIL THE LAST SCREW WHICH IS WHY SURGEON DID X-RAY. DID O-ARM SPIN AND NEW CASE TO REPLACE SCREWS THAT WERE BREACHED AND FINAL SCREWS.

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 CUSTOMER NOTICED THAT THE SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP WAS SEPARATED AND FELL OFF. UPON REMOVING THE INSTRUMENT TO CHECK, THE CUSTOMER FOUND SOME OF THE ACCESSORIES WERE NOT INTACT. THEY WERE ABLE TO RETRIEVE THE TIP, BUT SOME OF THE BROKEN PARTS COULD NOT BE CONFIRMED. THE CUSTOMER THEN CONDUCTED A LARGE AMOUNT OF IRRIGATION/SUCTION JUST IN CASE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND MCS TIP ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. DURING THE PROCEDURE, THE MCS TIP ACCESSORY AND FRAGMENTS FROM THE MCS INSTRUMENT FELL INTO THE PATIENT'S BODY AFTER BEING USED FOR LONGER THAN ONE HOUR TO DISSECT TISSUE. THE CUSTOMER RETRIEVED THE FRAGMENTS BUT COULD NOT CONFIRM IF THEY RETRIEVED ALL FRAGMENTS. THE CUSTOMER PERFORMED A LARGE AMOUNT OF IRRIGATION/SUCTION AS A PRECAUTIONARY MEASURE. POST-OPERATIVE TESTS AND ADDITIONAL SURGICAL PROCEDURES WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY I

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 PANCREATICODUODENECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE TIP WAS BROKEN, AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE WITH NO FURTHER CONSEQUENCES KNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS OF THE HARMONIC ACE WERE RETRIEVED USING A LAPAROSCOPIC INSTRUMENT. ALL THE FRAGMENTS WERE CONFIRMED TO BE RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE NEEDED AS THE FRAGMENTS WERE RETRIEVED USING LAPAROSCOPIC INSTRUMENTS DURING THE SAME PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THAT THE INSTRUMENT QUALITY WAS THE CAUSE OF THE BREAK. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES, IT WAS USED FOR AN HOUR PRIOR TO BREAK WHEN BEING USED FOR SEPARATING A BLOOD VESSEL. THERE WAS NO FUNCTIONALITY PROBLEM PRIOR TO THE BREAK. THERE WAS NO INSTRUMENT COLLISION, AND THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAK. UPON FINAL REMOVAL, THERE WAS NO R

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON SYSTEM BOOT UP, SYSTEM WOULD GET STUCK ON BLACK SCREEN WHERE NO BOOT MODE HAD BEEN SELECTED. THE SYSTEM WAS RESTARTED MULTIPLE TIMES AND STILL COULD NOT MAKE IT PAST THE BLACK BOOT MODE SELECT SCREEN. REQUESTING FSE SUPPORT TO ADDRESS COMPUTER/HARD DRIVES AND FIGURE OUT THE ROOT OF THIS PROBLEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT BROUGHT INTO ROOM AND TURNED ON WITHOUT ANY ISSUES. AFTER A COUPLE MINUTES THE SCREEN CHANGED TO A BLUE WINDOWS SCREEN STATING "YOUR PC RAN INTO A PROBLEM AND NEEDS TO RESTART. WE'LL RESTART FOR YOU." TRIED MULTIPLE RESTARTS AND ERROR STILL OCCURRED. CASE HAD TO BE ABORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, ANASTOMOTIC INSUFFICIENCY AT THE EDGE OF THE ANASTOMOSIS / STAPLE LINE OCCURRED. THE ISSUE WAS OBSERVED AFTER USING A SUREFORM STAPLER AND CHECKING PERFUSION OF THE ANASTOMOSIS WITH INDOCYANINE GREEN (ICG). THE STAPLE SUTURE HAD BEEN PROPERLY PLACED AND WAS CHECKED IN SITUS. THE THIRD-PARTY CIRCULAR STAPLER WAS NOTED TO BE WORKING PROPERLY.

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 UNSPECIFIED SURGICAL PROCEDURE, ANASTOMOTIC INSUFFICIENCY WITH AN INTRACORPORAL ANASTOMOSIS OCCURRED. THE ANASTOMOSIS WAS THEN SUTURED. THE SURGEON BELIEVES THIS ISSUE WAS DUE TO THE UNSPECIFIED SUREFORM STAPLER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SCREW PLACEMENT WAS SLIGHTLY OFF FROM THE PLAN.

Monarch Platform — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING BRONCHOSCOPY, THE PATIENT BECAME HYPOTENSIVE. THE CRITICAL CARE PULMONOLOGY TEAM WAS CALLED TO THE BEDSIDE. A CHEST TUBE WAS INSERTED AND AN IMMEDIATE GUSH OF AIR WAS OBSERVED. SHORTLY THEREAFTER THE PATIENT ARRESTED AND CPR WAS INITIATED. A LARGER-BORE CHEST TUBE WAS PLACED, RESULTING AGAIN IN A GUSH OF AIR. THE PATIENT WAS PRONOUNCED DEAD BY THE CRITICAL CARE TEAM. NECROTIC MATERIAL WAS EXPELLED DURING THE EVENT. A RAB (ROBOT-ASSISTED BRONCHOSCOPY) WITH 7-NEEDLE ASPIRATION WAS PERFORMED. THE DEATH WAS PRESUMED TO BE DUE TO A TENSION PNEUMOTHORAX. NO ISSUES WERE REPORTED WITH THE DEVICES USED DURING THE PROCEDURE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EGPS BATTERY DOES NOT HOLD ANYMORE. PLEASE SEND A FSR IMMEDIATELY TO REPLACE AND DO A SERVICE ON OUR MACHINE AT WESTCHESTER MEDICAL CENTER.

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 APPENDECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF WHEN REMOVED FROM THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED BUT ALMOST FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, AND WAS NOTED BY THE SCRUB UPON INSTRUMENT REMOVAL THAT THE TIP WAS GONE. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED. THE SURGEON WAS UNSURE WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE MCS INSTRUMENT WAS IN USE FOR 10 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT COLLISION WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE WAS MINIMAL. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE AND NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS IN

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 11-L3 PSF, BURST FRACTURE AT L1WITH DR. (B)(6) AT (B)(6). ALL SCREWS WERE PLACED IN A SERPENTINE ORDER WITHOUT ANY DIFFICULTY UP UNTIL RL3. 4.5 HS BURR WAS USED THEN DRILL WAS USED IN SCLEROTIC BONE. RESIDENT STRUGGLED GETTING THE DRILL THROUGH THE PEDICLE. DURING THIS TIME THE DRILL HAD SKIVED MEDIALLY. DR. (B)(6) AND RESIDENT TRIED RE-DRILLING AND TAPPING TO GET TO THE CORRECT TRAJECTORY. NAVIGATION LOOKED INTACT AT ALL TIMES. UPON GETTING A FINAL SPIN IT WAS NOTED THAT RL3 HAD JUST BREACHED MEDIALLY. DR. (B)(6) HAD DECIDED HE WOULD FREEHAND RL3 TO BRING IT LATERALLY. ANOTHER SPIN WAS PERFORMED AND THE SCREW WAS STILL MEDIAL. SCREW WAS TAKEN OUT AND PUT IN UNDER XRAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON MISSED SCREWS IN LOWER HALF OF THE CONSTRUCT AS IT APPEARED TO SHIFT. WE PERFORMED AN O-ARM SPIN AFTER SEEING SCREWS APPEARED OFF TRAJECTORY AND IT REVEALED THAT THERE WAS A SCREW THAT MISSED LATERALLY AND ONE MEDIALLY AT L1 AND L2. THEN TRIED TO REPOSITION SCREWS AFTER SPIN (2ND FILE) AND THEY DIDN'T WANT TO GOIN THE NEW TRAJECTORY SO IT WAS ABORTED.

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 AN INTERBODY SPACER WAS MISPLACED INTRA-OPERATIVELY WHILE USING THE EXCELSIUS GPS SYSTEM TO PREPARE THE DISC SPACE RESULTING IN A DURAL TEAR.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE DID AN L3-5 PSF WITH ROBOT USING MCS SCREWS. BOTH OF THE SCREWS AT L3 SHIFTED TO THE LEFT. THE RIGHT SCREW WENT MEDIAL AND THE LEFT SCREW WAS LATERAL. IT WAS IDENTIFIED BY NEUROMONITORING UPON STIMULATION AND THEN CONFIRMED WITH ANOTHER INFRA OP SPIN. WE BACKED THE SCREWS OUT AND REPLACED THEM WITH ROBOTIC GUIDANCE USING THE SECOND O-ARM SPIN. ALL OTHER SCREWS WERE FINE.

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 THE FIRST CASE OF THE DAY THE PHYSICIAN EXPERIENCED JUMPY NAVIGATION DURING THE PROCEDURE. THE CASE WAS ABORTED DUE TO THE NAVIGATION BEING OFF AND THE SCOPE COULD NOT PHYSICALLY MANEUVER IN THE AIRWAY. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BEFORE A CASE, WE WERE TRYING TO UPLOAD THE PATIENT SCAN AND THE ROBOT WAS NOT RECOGNIZING THE CD DRIVE. WE TRIED BOTH USB PORTS, DID A SOFTWARE RESET AND THEN A HARD RESET. WHEN TURNING BACK ON WE GOT A BLACK PAGE SAYING, "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY_".

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: THE ARM AND VERIFICATION PROBE WERE AGAIN USED TO CONFIRM THE ENTRY POINTS. A STRYKER PERFORATOR WAS USED TO CREATE A SINGLE BURR HOLE ON THE PATIENTS RIGHT. A STIM-LOCK WAS OPENED AND USED TO TEMPLATE AN AREA THAT THE SURGEON BURRED DOWN WITH A ACORN BIT TO RECESS THE STIM-LOCK. THE ARM WAS SENT AGAIN TO CONFIRM ACCURACY AT THE CENTER OF THE BURR HOLE. THE IGEE TOP TO TARGET WAS SET TO 183MM AND A 216.5MM ALPHA OMEGA CANNULA WAS PLACED TO APPROXIMATELY 10MM ABOVE TARGET. E3D WAS MOVED BACK INTO PLACE AND A SPIN WAS PERFORMED SHOWING A DEVIATION MEDIALLY APPROXIMATELY 1.25MM. THE SURGEON CHECKED ON THE BRAINLAB SERVER AND SAID THAT THEY SHOWED APPROXIMATELY 2.5MM OF DEVIATION. THE AO HEAD STAGE WAS REMOVED AND THE ARM RESETTLED, THIS TIME TO 168MM IGEE TOP TO TARGET. A 201.5MM AO CANNULA WAS PLACED AND E3D WAS MOVED BACK INTO TO POSITION AND ANOTHER SCAN WAS PERFORMED. IT WAS LOADED ONTO THE ROBOT AND AN EVALUATION SHOWED ALMOST IDENTICAL DEVIATION, SUGGESTING THE CANNULA FELL INTO THE PREVIOUS TRACK. THE SURGEON BELIEVED THE TRAJECTORY SET BY THE ROBOT WAS CORRECT, BUT THE CANNULA DEVIATED DUE TO POSSIBLE ANATOMY. HE ADJUSTED THE ALPHA OMEGA XY BASE TO CORRECT FOR THE DEVIATION AN

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TOMOYUKI ASADA , CHAD Z. SIMON , AMY Z LU , SAMUEL ADIDA , MARCEL DUPONT , PHILIP M PAREL , JOSHUA ZHANG , SATYAJ BHARGAVA , KYLE W. MORSE , JAMES E. DOWDELL , SRAVISHT IYER , SHEERAZ A QURESHI , ROBOT-NAVIGATED PEDICLE SCREW INSERTION CAN REDUCE INTRAOPERATIVE BLOOD LOSS AND LENGTH OF HOSPITAL STAY: ANALYSIS OF 1,633 PATIENTS UTILIZING PROPENSITY SCORE MATCHING, THE SPINE JOURNAL (2023), DOI: HTTPS://DOI.ORG/10.1016/J.SPINEE.2023.09.004 BACKGROUND CONTEXT: NAVIGATION AND ROBOTIC TECHNOLOGIES HAVE EMERGED AS AN ALTERNATIVE OPTION TO CONVENTIONAL FREEHAND TECHNIQUES FOR PEDICLE SCREW INSERTION. HOWEVER, THE EFFECTIVENESS OF THESE TECHNOLOGIES IN REDUCING THE PERIOPERATIVE COMPLICATIONS OF SPINAL FUSION SURGERY REMAINS LIMITED DUE TO THE SMALL COHORT SIZE IN THE EXISTING LITERATURE. PURPOSE: TO INVESTIGATE WHETHER UTILIZATION OF ROBOTICALLY NAVIGATED PEDICLE SCREW INSERTION CAN REDUCE THE PERIOPERATIVE COMPLICATIONS OF SPINAL FUSION SURGERY¿INCLUDING REOPERATIONS¿WITH A SIZEABLE COHORT. STUDY DESIGN: RETROSPECTIVE STUDY. PATIENT SAMPLE: PATIENTS WHO UNDERWENT PRIMARY LUMBAR FUSION SURGERY BETWEEN 2019 AND 2022. OUTCOME MEASURES: PERIOPERATIVE COMPLICATIONS INCLUDING READMISSION, REOP

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 PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A PATIENT SIDE CART (PSC) RUNNING ON BATTERY MESSAGE. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY HAVE ALREADY TRIED MULTIPLE OUTLETS AND HARD POWER CYCLED THE SYSTEM WITH AN EMERGENCY POWER OFF (EPO) OF THE PSC WITH NO CHANGE. THE ISI TSE RECOMMENDED ANOTHER REBOOT WITH EPO IF POSSIBLE. THE ISI TSE ALSO RECOMMENDED INFORMING THE SURGEON IF THEY ONLY HAVE BATTERY POWER ON THE PSC, THEY WILL NOT HAVE POWER FOR VERY LONG DEPENDING ON THE CURRENT STATUS OF THE BATTERY AND MAY NOT WANT TO START A PROCEDURE WITH ONLY BATTERY POWER. ERROR LOGS SHOW 417 ERRORS FOR BOTH POWER SUPPLY 1 AND 2. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SP SYSTEM WAS REMOVED FROM THE ROOM AND DA VINCI XI WAS BROUGHT IN TO CONTINUE THE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, A "SHEATH" FELL INSIDE THE PATIENT AND WAS RECOVERED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF ANY PATIENT HARM OR INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SURGEON TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN RECEIVED.

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 LEFT HEMICOLECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE WHILE THE SURGEON WAS DISSECTING. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP HARMONIC ACE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. 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. DURING THE PROCEDURE, THE INSTRUMENT TIP BROKE OFF AND FELL INSIDE THE PATIENT'S CAVITY AFTER USING IT FOR 15 MINUTES. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH A VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURES AND POST-OPERATIVE TESTS WERE NOT PERFORMED. ADDITIONALLY, 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 MATERIALS DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. BOTH THE INSTRUMENT AND CANNULA HAD NO OTHER DAMAGE AFTER THE EVENT

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NAGATA K, GLASSMAN SD, BROWN ME, DANIELS CL, SCHMIDT GO, CARREON LY, HINES B, GUM JL. RISK FACTORS OF SCREW MALPOSITION IN ROBOT-ASSISTED CORTICAL BONE TRAJECTORY: ANALYSIS OF 1344 CONSECUTIVE SCREWS IN 256 PATIENTS. SPINE (PHILA PA 1976). 2023 SEP 28. DOI: 10.109 7/BRS.0000000000004827. EPUB AHEAD OF PRINT. PMID: 37767783. OBJECTIVE: TO DESCRIBE THE INCIDENCE OF AND IDENTIFY RISK FACTORS FOR INTRAOPERATIVE SCREW MALPOSITION SECONDARY TO SKIVE OR SHIFT DURING ROBOT-ASSISTED CORTICAL BONE TRAJECTORY (RACBT) INSERTION. METHODS: A CONSECUTIVE SERIES OF PATIENTS OLDER THAN 18 YEARS WHO UNDERWENT RA-CBT SCREW PLACEMENT BETWEEN JANUARY 2019 AND JULY 2022 WERE ENROLLED. BASELINE DEMOGRAPHIC AND SURGICAL DATA, HOUNSFIELD UNITS (HU) AT L1, AND VERTEBRAL SHAPE RELATED TO SCREW PLANNING WERE COLLECTED. SKIVE OR SHIFT WAS RECORDED IN THE OPERATING ROOM ON A DATA COLLECTION FORM. RESULTS: OF 1344 CBT SCREWS IN 256 PATIENTS, MALPOSITION WAS RECOGNIZED INTRAOPERATIVELY IN 33 SCREWS (2.4%) IN 27 PATIENTS (10.5%); 19 VIA SKIVE IN 17 AND 14 VIA SHIFT IN 10 PATIENTS. THESE PATIENTS HAD HIGHER BMI THAN PATIENTS WITHOUT MALPOSITION (33.0 KG/M2 VS 30.5 KG/M2, P=0.037). PATIENTS WITH SKIVE HAD HIGHER HU

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 CASE USING CT-FLUORO REGISTRATION WORKFLOW. DURING PATIENT REGISTRATION, USER COULD NOT ACHIEVE AN ACCURATE MERGE OF PRE-OP CT TO INTRA-OPERATIVE FLUORO SHOTS. REQUESTING SOFTWARE INVESTIGATION OF THE MERGE ATTEMPTS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT RECOGNIZED, NOT WORKING AT THE MIDDLE OF THE SURGERY, AND THE TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE INSTRUMENT WAS INSPECTED BEFORE THE PROCEDURE. THE SURGEON WAS DISSECTING WHEN THE REPORTED ISSUE OCCURRED. THE SURGERY HAD STARTED ABOUT 2 HOURS BEFORE THE ISSUE OCCURRED. THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS. THE INSTRUMENT WRIST WAS STRAIGHTENED TO REMOVE WITH NO RESISTANCE. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER AND WAS VISUALLY CONFIRMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L4R WAS PLANNED ON A POTENTIAL SKIVE ZONE DUE TO THE PATIENT'S ANATOMY AND THE SURGEON'S TRAJECTORY PREFERENCE (STRAIGHT UP AND DOWN, MID-LINE ALONG THE FACET JOINT, WHICH WAS HYPERTROPHIC IN THIS CASE). THE SURGEON'S TECHNIQUE IS EXTREMELY FAST WITH THE HS BURR, RD, AND DRIVER ALL ON POWER. HE PLACED THE SCREWS AT L4R VERY QUICKLY AND MOVED ONTO THE NEXT. THE EGPS BASE HAD TO BE BACKED AWAY FROM THE PATIENT DUE TO THE ARM CONTRACTING THE PATIENT ANATOMY AND THE LAST TWO SCREWS WERE PLACED WITHOUT ISSUE. THE C-ARM WAS BROUGHT IN FOR CONFIRMATION SHOTS AND IT WAS FOUND THAT THE L4R SCREW HAD SKIVVED OFF OF THE HYPERTROPHIC FACET AND HAD ANGLED CRANIAL, MISSING THE PEDICLE. HOWEVER, THE SOFTWARE HAD GIVEN A CHECKMARK FOR THIS TRAJECTORY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN NAVIGATING DRIVER, NAVIGATION LOOKED ACCURATE, IF ANYTHING SLIGHTLY OFF TRAJECTORY LATERALLY IN OUR AXIAL SLICE (STILL SAFELY IN BONE), BUT ACCURATE TO PLAN IN SAGITTAL. SINCE SCREW WAS OFFSET LATERALLY, THERE WAS DIFFICULTY INSERTING THE ARRAY ALL THE WAY THROUGH EE AND DOCTOR FELT TACTILE FEEDBACK WAS OFF, DRIVER WAS REMOVED AND C-ARM WAS BROUGHT IN FOR IMAGES. THE SCREW WAS INSERTED ON PLAN BUT AND HALFWAY THROUGH THE PEDICLE BROKE OUT SUPERIOR AND WAS IN DISC SPACE (FLUORO SHOT INCLUDED). THIS DID NOT SHOW ON NAVIGATION. MINOR ADJUSTMENTS WERE MADE TO THE PLAN. HIGH SPEED BURR WAS INSERTED THROUGH EE INTO PRIOR HOLE AND FLUORO SHOW ACCURATE TO PLAN, SAME WITH 3.5MM PILOT DRILL. A NEW SCREW WAS INSERTED TO PLAN AND NO ADVERSE EFFECTS TO THE PATIENT WERE PRESENTED THROUGH NEUROSTIMULATION.