ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROCEDURE WAS A L2-L4 LUMBAR FUSION. BEGINNING OF THE CASE WAS NORMAL: INTRAOP WORKFLOW WITH E3D. DRB WAS PLACED IN THE R PSIS, AND SURVEILLANCE MARKER PLACED IN L PSIS (SUCCESSFULLY ACTIVATED). SET UP, IMAGING, AND PLANNING OF THE SCREWS ALL COMPLETED WITHOUT ANY ISSUES. HOWEVER, WHEN MOVING THE ROBOT WITHIN NAVIGATION RANGE, SURGICAL TEAM MOVED EE VIA BRACELET INTO THE DRB, CAUSING IT TO VISIBLY SHIFT. HOWEVER, UPON REPOSITIONING OF THE ARM, DRB APPEARED TO MOVE BACK INTO ORIGINAL LOCATION. THE POST IN THE PSIS WAS CHECKED, AND APPEARED STABLE. FOLLOWING THIS, LANDMARK CHECKS WERE COMPLETED AND IT WAS DECIDED THAT ANATOMY/NAVIGATIONAL INTEGRITY APPEARED ACCURATE. FOLLOWING PLACEMENT OF ALL 6 SCREWS, 1 SCREW (R L2) WAS FAR TOO LATERAL, AND THE DECISION WAS MADE TO REMOVE THE SCREW AND NAVIGATE A NEW SCREW. A SECOND CASE WAS MADE, AND THE POST-OPERATIVE E3D SPIN WAS USED FOR A PRE-OP PROTOCOL. MERGE WAS SUCCESSFUL, HOWEVER THE SCREW PLACEMENT WAS AGAIN LATERAL. WE ARE CERTAIN THERE WAS A DRB SHIFT DURING THE FIRST PORTION OF THE CASE, CAUSING THE SCREWS TO APPEAR LATERAL. HOWEVER WE ARE UNSURE AS TO WHY THE REPLACEMENT SCREW WAS ALSO LATERAL. OUR THOUGHT IS THAT IT MAY HAVE SLID IN

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, THE PATIENT REPORTED HAVING HYPOXIA WHICH IS A PRE-EXISTING CONDITION THAT IS ATTRIBUTED TO MEDICAL HISTORY OF COPD. THE PATIENT WAS HOSPITALIZED AND SUPPLEMENTAL OXYGEN (3L 02) WAS GIVEN AND RELEASED THE FOLLOWING DAY. NO ISSUES WERE REPORTED REGARDING THE MONARCH SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT WAS USED FOR CASE THIS AM WITH DR. (B)(6) WITH NO ISSUES. ROBOT WAS THEN MOVED TO ROOM ACROSS THE HALL FOR USE WITH DR. (B)(6). UNPLUGGED AND REPLUNGED INTO THE NEW ROOM, IN THAT TIME THE BATTERY WAS NO LONGER SHOWING AS BEING PLUGGED IN. THEY TRIED MULTIPLE OUTLETS AND HARD RESTARTS TO NO AVAIL. THEY ARE LOOKING FOR A RESOLUTION AS SOON AS POSSIBLE, BUT LIKELY WILL BAIL ON CURRENT CASE. LIKELY NEED A FUSE REPLACEMENT.

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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT. THE CUSTOMER REMOVED THE SHEATH FROM THE PATIENT. THE MCS TIP COVER WAS THROWN OUT AND WILL NOT BE RETURNED. THE PROCEDURE WAS COMPLETED. 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: SURGEON AND OTHER STAFF WERE USING THE DAVINCI XI FOR A UROLOGICAL PROCEDURE. THE OUTFIELD AND INFIELD MONITORS IN THE OPERATING ROOM FLICKERED MULTIPLE TIMES THROUGHOUT CASE IN OPERATING ROOM AND EVENTUALLY WENT BLACK. REDUCED VISUALIZATION AND INABILITY TO SEE VISION TOWER RESULTED IN SMALL NICK TO BLADDER NECK. PHYSICIAN ABLE TO REPAIR TEAR. THIS ISSUE OF MONITORS FLICKERING AND GOING BLACK HAS HAPPENED MANY TIMES BEFORE, BUT WITHOUT INJURY TO A PATIENT. MANUFACTURER RESPONSE FOR DAVINCI XI MONITORS, DAVINCI XI (PER SITE REPORTER). MANUFACTURER WILL ARRIVE NEXT WEEK TO TROUBLESHOOT THE DEVICE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY THE PHYSICIAN REMOVED A FOREIGN OBJECT WHILE WITHDRAWING THE SPECIMEN TISSUE FROM THE SPECIMEN.

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 SIGMOID COLECTOMY SURGICAL PROCEDURE THAT TIP-UP FENESTRATED GRASPER INSTRUMENT HAD ENGAGEMENT ISSUES. THE PROCEDURE WAS COMPLETED AS AN OPEN PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: IT WAS REPORTED TO THE INITIAL REPORTER THAT THE INSTRUMENT DIDN'T WORK AND/OR BROKE DURING THE PROCEDURE AND THAT THE PROCEDURE WAS CHANGED TO AN OPEN PROCEDURE. REPORTEDLY, THE CONVERSION TO AN OPEN PROCEDURE DID NOT HAVE ANYTHING TO DO WITH THE INSTRUMENT BREAKING.

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 STAPLER STOPPED IN THE MIDDLE OF THE FIRING PROCESS AND DID NOT COMPLETE FIRING. STAPLER AND RELOAD WERE RETRIEVED FROM PATIENT AND PROCEDURE CONTINUED LAPAROSCOPICALLY INSTEAD OF WITH THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE THE ARM WAS MOVING TO NEW TRAJECTORY WE RECEIVED THE YELLOW ERROR MESSAGE THAT SAID THAT WE WERE APPLYING TOO MUCH FORCE ON EE, AND THE ARM STOPPED MOVING.THE SURGEON CANCELED THE MESSAGE AND TRIED TO REACH THE TRAJECTORY BY PRESSING ON THE PEDAL MULTIPLE TIMES BUT WE ALWAYS RECEIVED THE SAME ERROR MESSAGE.

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 DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, BLEEDING WAS NOTED. THE PHYSICIAN CONVERTED THE PROCEDURE TO A TRADITIONAL BRONCHOSCOPY AND A BALLOON WAS USED TO PROVIDE TAMPONADE. PER THE PHYSICIAN, THE PRIMARY CAUSE OF THE PATIENT BLEED WAS DUE TO THE PATIENT¿S FRAGILE AIRWAYS AND PRE-EXISTING CONDITION. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO HOSPITALIZATION REQUIRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BLADE FRACTURED, AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BACKUP DA VINCI INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED USING THE ENDOSCOPE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED AND THERE WERE NO POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THE ISSUE WAS AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS BEING USED FOR DISSECTING FOR ABOUT 40 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES FOUND. THE SYSTEM SHOWED THAT THE SURGEON NEEDED TO REDUCE THE INSTRUMENT TIP PRESSURE. THERE WAS NO INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED PRIOR TO THE BREAKAGE DURING THE PROCEDURE WHEN CLEANING THE INSTRUMENT. UPON FINAL REMOVAL, THERE WAS NO RESISTANCE, NO DAMAGE TO THE CANNULA, AND NO ADDITIO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT UNDERWENT A SINGLE PORT DA VINCI-ASSISTED PARTIAL NEPHRECTOMY ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES MALFUNCTION OCCURRED DURING THE SURGERY. THERE WERE ALSO NO INTRA-OPERATIVE COMPLICATIONS REPORTED. ON (B)(6) 2023, THE PATIENT EXPERIENCED BILATERAL DEEP VEIN THROMBOSIS OF THE LEFT LOWER EXTREMITIES. A VASCULAR ULTRASOUND WAS PERFORMED AND CONFIRMED THE DIAGNOSIS. ENOXAPARIN 4000IU WAS GIVEN FOR THE THROMBOSIS. ON (B)(6) 2023, THE PATIENT WAS FOUND WITH A HEMATOMA IN THE LEFT RENAL AREA FROM A ULTRASOUND. NO MEDICAL INTERVENTION WAS PERFORMED FOR THE FINDING. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITHOUT REQUIRING PROLONGED HOSPITALIZATION. THE PATIENT HAD MEDICAL HISTORY OF URINARY SYSTEM DISEASE AND SIMPLE RENAL CYST AT LEFT KIDNEY. THE STUDY INVESTIGATOR THOUGHT THE BILATERAL DEEP VEIN THROMBOSIS WAS LIKELY CAUSED BY INTRAOPERATIVE PNEUMOPERITONEUM AND THE CAUSE OF THE RENAL HEMATOMA WAS DUE TO ANTICOAGULATIVE MEDICATION. IT WAS CONFIRMED THAT THERE WAS NO UNEXPECTED BLEEDING THAT COULD HAVE LED TO THE RENAL HEMATOMA.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS FAILING TO COMMUNICATE WITH C-ARM. ALL FIELD TROUBLESHOOTING HAS FAILED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A DA VINCI SINGLE PORT ASSISTED RADICAL PROSTATECTOMY FOR HIS PROSTATE CANCER AS PART OF A CLINICAL STUDY ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS NOR ANY MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES. ON (B)(6) 2023, AN ULTRASOUND SHOWED MULTIPLE CYSTIC FOCI IN BOTH KIDNEYS AND WAS SUSPECTED AS RENAL CYSTS, WHICH LIKELY CAUSED BY PATIENT'S MEDICAL CONDITIONS. A LYMPHATIC LEAK WAS ALSO SUSPECTED AND ASCITES ASPIRATION WAS PERFORMED ON (B)(6) 2023, DRAINAGE ON (B)(6) 2023 AS MEDICAL INTERVENTION. FURTHERMORE, A CT-GUIDED PUNCTURE AND PELVIC EFFUSION WAS PERFORMED ON (B)(6) 2023 AND THE SYMPTOMS WERE REPORTED AS RESOLVED ON (B)(6) 2023. THE PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO PERSONAL REASONS AND WAS DISCHARGED ON (B)(6) 2023.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT HAS HAD 4 MISPLACED SCREWS IN THE LAST WEEK.

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 RECURRENT FAULT STATE OCCURRED DURING THE SETUP OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE HEAD BROKE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE TIP BROKE INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND ALL FRAGMENTS WERE FOUND. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE NEEDED. NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON BELIEVES THE ISSUE IS DUE TO PRODUCT QUALITY. THE INSTRUMENT WAS USED FOR 10 MINUTES PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH INSTRUMENT FUNCTIONALITY PRIOR TO THE BREAK. THERE WAS NO INSTRUMENT COLLISION. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO ADDITIONAL DAMAGE TO THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL RELATED TO RETAINING A FOREIGN OBJECT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT 8:45AM THE ROBOT WAS PLUGGED IN AND TURNED ON. EVERYTHING SEEMED TO BE WORKING FINE. ROBOT WAS LEFT ON AND PLUGGED IN. 11:15AM ROBOT WAS ROLLED INTO SURGERY ROOM 5 AND PLUGGED IN. A O-ARM SPIN WAS COMPLETED AND THE SCAN WAS LOADED AS A PRE-OP CT. SCAN WAS LOADED TO THE ROBOT WITH NO ISSUES, AND SCREWS WERE PLANNED ACCORDING TO LEVEL AND BILATERAL ORIENTATION. SURGEON THEN BEGAN TO FINE TUNE THE SCREWS, AND AT THIS POINT THE MONITOR SHUT OFF AND MONITOR LIGHT TURNED RED, A BLUE TEXT BOX APPEARED SAYING "NO SYNC". THE SCREW BEGAN TO REBOOT GOING THROUGH NORMAL BOOTING SCREWS AND THEN TO LOGIN SCREEN, AS THE SCREEN WAS REBOOTING THE MONITOR LIGHT WAS BLUE. WE LOGGED BACK IN AND THE SURGEON BEGAN FINE TUNING, THEN IT SHUT DOWN AGAIN. AT THIS POINT I CHANGED THE OUTLET THAT THE ROBOT WAS PLUGGED INTO AS IT REBOOTED. I NOTICED THAT THE FANS WERE TURNING OFF THEN BACK ON DURING THE REBOOTING PROCESS. ONCE REBOOTED AND PLAN PULLED UP WE RECEIVED A "MOTION COMMUNICATION ERROR" WE CLICKED OUT OF IT AND STARTED TO FINE TUNE AGAIN. THE SURGEON WAS ABLE TO GET A WHOLE LEVEL DONE AND THEN IT DID IT AGAIN. WE TRIED ONE MORE TIME BEFORE IT REBOOTED A SURGEON DECIDED TO BAIL ON THE ROBOT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PART OF THE SYNCHROSEAL INSTRUMENT CAME OUT. THE PART WAS RETRIEVED. A BACK UP INSTRUMENT WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A BENIGN HYSTERECTOMY. IT IS UNKNOWN HOW THE FRAGMENT FELL INTO THE PATIENT. THE EYELET WAS SPOTTED IN THE PATIENT, AND THEN THEY REALIZED WHAT IT WAS WHEN THEY SAW THE EYELET MISSING ON THE SYNCHROSEAL. NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NOT ANY POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE FRAGMENT WILL BE RETURNING WITH THE INSTRUMENT. IMAGES WERE PROVIDED. PARTIAL DEVICE INFORMATION PROVIDED WITH RETURN IMAGES.

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 SUDDENLY STOPPED WORKING AND THE SYSTEM PROMPTED THE CUSTOMER TO CHANGE THE INSTRUMENT. THE CUSTOMER REMOVED THE FRACTURED PART OF THE INSTRUMENT COMPLETELY AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE 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 DURING A DIAGNOSTIC MONARCH BRONCHOSCOPY PROCEDURE, BLEEDING WAS DETECTED DURING THE BIOPSY, AND THE SYSTEM WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A MANUAL SCOPE TO SUCTION BLOOD AND A BLOOD CLOT FROM THE LUNG. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TRANSFERRED TO THE ICU WHERE A PNEUMOTHORAX WAS DETECTED. THE PATIENT WAS TREATED WITH A CHEST TUBE AND REMAINS IN THE ICU. THERE WAS NO DIFFICULTY EXPERIENCED DURING THE BIOPSY AND THERE WERE NO REPORTED DEVICE ISSUES RELATED TO THIS EVENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN REGISTERING T12, C-ARM SHOTS WERE NOT ALIGNING WITH PREOP SEGMENT OF THE PATIENT'S BODY ALTHOUGH MERGE SCORES WERE ACCEPTABLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN RESPONSE TO AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SURVEY ON XI / X MONOPOLAR INSTRUMENTS, A CUSTOMER RECALLED AN EVENT REGARDING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT WAS CONVERTED TO OPEN SURGERY DUE TO A MALFUNCTION AND / OR BREAKAGE OF AN UNSPECIFIED DA VINCI MONOPOLAR INSTRUMENT. THE CUSTOMER DID NOT SPECIFY THE NUMBER OF CONVERSIONS FROM DA VINCI SURGICAL PROCEDURE TO OPEN SURGERY FOR MALFUNCTION / BREAKAGE. THE CUSTOMER WHO RESPONDED TO THE SURVEY WAS ANONYMOUS. THE CUSTOMER DID NOT COMPLETE THE ENTIRE SURVEY LEADING TO INCOMPLETE 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY BROKE AND A PIECE FELL INSIDE THE PATIENT. THE FRACTURED PART WAS TAKEN OUT OF THE PATIENT DURING THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO CONTINUE WITH THE PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE SITE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. THE ISSUE OCCURRED ABOUT 1 HOUR AFTER THE PROCEDURE STARTED AND AS THE SURGEON WAS GRASPING TISSUE. THE SURGEON NOTICED UNSPECIFIED FUNCTIONALITY ISSUES WITH THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE OCCURRED. THE INSTRUMENT'S WRIST WAS STRAIGHTENED PRIOR TO REMOVAL AND THE OR STAFF DID NOT FEEL RESISTANCE WHILE REMOVING THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY THE ASSISTANT AND WERE REMOVED WITH ANOTHER FORCEPS. NO ADDITIONAL SURGICA

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 ADRENALECTOMY SURGICAL PROCEDURE, WHEN THE SYNCHROSEAL INSTRUMENT WAS BEING REMOVED, IT MADE SOME ABNORMAL MOVEMENTS AND A SMALL PIECE OF IT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON DOES NOT KNOW WHAT CAUSED THE FRAGMENT FAILING ISSUE. THE EXACT TIME OF HOW LONG THE INSTRUMENT WAS IN USE PRIOR TO THE ISSUE OCCURRING WAS UNKNOWN, BUT IT WAS DURING THE INITIAL WORK. 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 SURGEON SAW THE FRAGMENT FALL AS THE INSTRUMENT WAS BEING REMOVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO PATIENT INJURY. THE PATIENT HAD NOT RETURNED TO T

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE AT (B)(6) WAS A L4/L5 OPEN TLIF WITH CREO AMP USING THE PREOP WORKFLOW ON AN EGPS SYSTEM THAT IS RUNNING SPINE 1.4. EXPOSURE WAS MADE AND DRB WAS PLACED ON A SPINOUS PROCESS CLAMP AT L3 WITH THE CAMERA AT THE HEAD. SURVEILLANCE WAS PLACED IN LEFT PSIS. FLOURO IMAGES WERE ACQUIRED FOR REGISTRATION AND DUE TO SOME PRIOR ISSUES WITH THE MERGE, CAREFUL ATTENTION WAS PAID TO GETTING MORE TRUE IMAGES AND ALSO TO KEEP THE DRB AS MUCH OUT OF THE SHOTS AS POSSIBLE AS TO NOT INTERFERE WITH THE FIXTURE BBS. AFTER THE MERGE WAS RUN, IT WAS DETERMINED THAT AT L4 THE WAS SOME ANTERIOR POSTERIOR SHIFT IN THE LATERAL. ANOTHER REGISTRATION TYPE WAS SELECTED AND DEEMED SATISFACTORY. DUE TO THE INCISION, DR. (B)(6) ELECTED TO START AT L4 AND WORKED TOWARD L5. THE LAST SCREW PLACED WAS L5R AND A LOT OF RETRACTION WITH A VERSATRAC WAS USED TO BE ABLE TO PLACE SCREW INSIDE THE INCISION. UNFORTUNATELY DO THE WORKFLOW AND ROOM SET UP, SURVEILLANCE WAS UNABLE TO BE SEEN. UPON XRAY CONFIRMATION SHOTS, IT WAS DETERMINED THAT THE L5R SCREWS WAS LATERAL TO THE PLAN. THE SCREW WAS REMOVED, AND AN ACCURACY CHECK WAS PERFORMED AND DEEMED SATISFACTORY. THE SCREW WAS REINSERTED UNDER A NEW PLAN AFTER FREE HAND

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HERNANDEZ, N. S., DIAZ-AGUILAR, L. D., & PHAM, M. H. (2023). SINGLE POSITION L5-S1 LATERAL ALIF WITH SIMULTANEOUS ROBOTIC POSTERIOR FIXATION IS SAFE AND IMPROVES REGIONAL ALIGNMENT AND LORDOSIS DISTRIBUTION INDEX. EUROPEAN SPINE JOURNAL. HTTPS://DOI.ORG/10.1 007/S00586-023-07841-Y. PURPOSE: MINIMALLY INVASIVE SINGLE POSITION LATERAL ALIF AT L5-S1 WITH SIMULTANEOUS ROBOT-ASSISTED POSTERIOR FIXATION HAS TECHNICAL AND ANATOMIC CONSIDERATIONS THAT NEED FURTHER DESCRIPTION. METHODS: THIS IS A RETROSPECTIVE CASE SERIES OF SINGLE POSITION LATERAL ALIF AT L5-S1 WITH ROBOTIC ASSISTED FIXATION. END POINTS INCLUDED RADIOGRAPHIC PARAMETERS, LORDOSIS DISTRIBUTION INDEX (LDI), COMPLICATIONS, PEDICLE SCREW ACCURACY, AND INPATIENT METRICS. RESULTS: THERE WERE 17 PATIENTS WITH MEAN AGE OF 60.5 YEARS. EIGHT PATIENTS UNDERWENT INTERBODY FUSION AT L5-S1, FIVE PATIENTS AT L4-S1, TWO PATIENTS AT L3-S1, AND ONE PATIENT AT L2-S1 IN SINGLE LATERAL POSITION. OPERATIVE TIMES FOR 1-LEVEL AND 2-LEVEL CASES WERE 193 MIN AND 278 MIN, RESPECTIVELY. MEAN EBL WAS 71 CC. MEAN IMPROVEMENTS IN L5-S1 SEGMENTAL LORDOSIS WERE 11.7 ± 4.0°, L1-S1 LORDOSIS OF 4.8 ± 6.4°, SAGITTAL VERTICAL AXIS OF - 0.1 ±1.7 CM°, PELVIC TILT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PRE-OP BASED L3-L5 OPEN CASE WAS BEING PERFORMED AND THE MERGE LOOKED GOOD BY VERIFYING THE ANATOMICAL LANDMARK. AS IT WAS AN OPEN CASE, SURGEON HAS NOT USED SM TO AVOID AN ADDITIONAL INCISION/FIXATION ON PSIS. AFTER PLACING ALL THE SIX SCREWS A POST OP XRAY HAS BEEN TAKEN. FIRST SCREW I.E. L3-L WAS NOT PLACED AS PER THE PLAN AND ENTERED INTO L2-L3 DISK. THERE WAS NO ADVERSE EFFECT TO PATIENT AND THE SCREW WAS CORRECTED MANUALLY. REST ALL OTHER SCREWS WERE FINE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT HAS HAD MULTIPLE DIFFERENT FAILURES OF THE STABILIZER ENGAGEMENT.

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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT A RECOVERABLE FAULT WAS REOCCURRING EACH TIME THE RECOVER FAULT WAS SELECTED. THE SYSTEM WAS NOT AVAILABLE ON ONSITE AND THE CUSTOMER EMAILED EVENT LOG IMAGE TO THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE). THE EVENT LOG IMAGE CONFIRMED ERROR 32100 AND INDICATED THAT THE ERROR WAS REPORTED BY SOAM-A AND POINTED TO THE EGM YAW BRAKE CURRENT IN THE YAW MOTOR ASSEMBLY. THE TSE RECOMMENDED TO PERFORM AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC), BUT THE ERROR PERSISTED. THE CUSTOMER STATED THAT THEY WERE GOING TO ATTEMPT TO CONVERT THE PROCEDURE TO MULTIPORT, USING THEIR XI SYSTEM. THE PROCEDURE WAS CONVERTED FROM A SINGLE-PORT SYSTEM TO AN XI DA VINCI SYSTEM. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS 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: 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: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME 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 A RECURRENT FAULT STATE OCCURRED DURING INITIAL SYSTEM REGISTRATION OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. 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: PROCEDURE WAS A PREOP CT T9 TO THE PELVIS. THE CASE WAS STAGED WITH THREE LEVELS OF LATERAL FROM L1-L4 COMPLETED THE DAY PRIOR, A PREOP CT TAKEN AND THEN AN ALIF AT 5-1 THE DAY OF THE POSTERIOR PORTION. AFTER THE ALIF, PATIENT WAS FLIPPED, AND A SMALL SKIN LEVEL INCISION WAS MADE FROM T9 TO THE PELVIS - NOT MUCH EXPOSURE WAS PERFORMED AS THE SCREWS WERE GOING TO BE INSERTED USING CREO MIS. FLOURO IMAGES WERE ACQUIRED, AND THE MERGE WAS ACCURATE AT ALL LEVELS EXCEPT FOR L4. NEW IMAGES WERE ACQUIRED, AND THE MERGE WAS RERUN WHICH IMPROVED AT L4. WE BEGAN INSERTING SCREWS AT T9 AND SNAKED DOWN TO THE PELVIS. IN THE PELVIS WE WERE GOING TO BE PLACING TWO CREO S2AI SCREWS AND TWO MEDIAL TO LATERAL SI LOK SELECT SCREWS. THE ORDER IN WHICH THEY WERE PLACED WAS CREO S2AI LEFT, SILOK SELECT LEFT, CREO S2AI RIGHT, SILOK SELECT RIGHT - DUE TO THE DRB BEING PLACED IN RIGHT PSIS ON LOW PROFILE QUATTRO SPIKE. FLOURO IMAGES WERE TAKEN, AND ALL THE SCREWS SEEMED TO BE PLACED CORRECTLY. DR. (B)(6) THEN PROCEEDED TO DROP THE RODS AND AFTER THIS WAS COMPLETED, WE ACQUIRED TWO O ARM SPINS TO CHECK ALL OF THE INSTRUMENTATION. AFTER REVIEW OF SCANS, ALL SCREWS WERE PLACED ACCURATELY EXCEPT FOR S2AI ON T

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS AN INTRAOP CASE WITH ZIEHM 3D, SOFTWARE 1.1R3. THE SCAN WAS TRANSFERRED WITH THE USB, UNFORTUNATELY, WE DIDN'T GET AUTOMATIC REGISTRATION AND DID IT MANUALLY. THE ANATOMICAL LANDMARK CHECK HAD BEEN DONE. THE ACCURACY WAS GOOD. THE FIRST SCREW L5-L WAS PLACED WITH GOOD NAVIGATION ACCURACY. BY THE SECOND SCREW L5-R, EE WAS ON THE TRAJECTORY, WITH A GREEN BORDER AND OFFSET. UNFORTUNATELY, WE COULD NOT SEE THE HIGH-SPEED DRILL INSIDE THE EE. THE TOOL WAS VISIBLE TO THE CAMERA OUTSIDE THE EE. THE SURGEON CHECKED THE NAVY ACCURACY, IT WAS NOT ACCURATE ANYMORE. THE SURGEON PLACED THE SCREWS IN THE TRADITIONAL WAY.

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 BLADE WAS BROKEN. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED WITH THE PROCEDURE.

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 ON THE PATIENT¿S POST PROCEDURAL X-RAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ASYMPTOMATIC. NO ADDITIONAL INTERVENTION WAS NECESSARY, AND THE PATIENT WAS DISCHARGED ONE (1) DAY LATER. 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 DA VINCI-ASSISTED LIVER CYSTECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT CLAMP CRACKED OPEN 8 MINUTES INTO THE PROCEDURE. THE BROKEN OFF INSTRUMENT FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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: AS WE ATTEMPTED TO SEND THE CT SCAN, WE GOT A "CAMERA DISCONNECTED ERROR," EVEN THOUGH CAMERA WAS PLUGGED IN. WE ALSO GOT A "UAIB VERSION OUTDATED ERROR" MESSAGE WHILE TRYING TO RECEIVE A SCAN. THE CAMERA THEN STOPPED BEING ABLE TO PICK UP END EFFECTOR ON THE VERIFY PAGE.

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.