ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE MATCHING WAS DONE AND WE STARTED TO APPROACH WITH THE ROBOT. THE SCREWS WERE ONLY NECESSARY ON THE RIGHT SIDE, SO WE GOT ALL THREE RIGHT SCREWS GREEN FRAME AND STABILIZED THE ROBOT IN THAT POSITION. SELECTED A SCREW AND PRESSED THE FOOTPADDLE, WITH THE IMMEDIATELY GOT THE MESSAGE TRAJECTORY OUT OF RANGE. IT STAYED LIKE THAT AFTER SOFTWARE RESET, SWITCH TO CRANIAL AND BACK AND TO 3 HARD SHUTDOWNS INCLUDING PULLING OUT THE ELECTRIC CORD. NOTHING CHANGED THE TRAJECTORY OUT OF RANGE MESSAGE.

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: ON (B)(6) 2023 IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN FELT A POP WHILE TAKING A BIOPSY WITH A MEDTRONIC ARCPOINT NEEDLE. AFTER COMPLETING THE BIOPSY, THE PHYSICIAN REMOVED THE BRONCHOSCOPE SYSTEM AND THE PATIENT¿S HEART RATE SPIKED TO A REPORTED 190 BPM. AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED, AND IT WAS DETERMINED THAT NO FURTHER INTERVENTION WAS REQUIRED AT THAT TIME. THE PATIENT WAS TRANSFERRED TO POST ANESTHESIA CARE UNIT (PACU), A CHEST X-RAY WAS PERFORMED, AND A PNEUMOTHORAX WAS CONFIRMED. A CHEST TUBE WAS PLACED, THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND RELEASED 3 DAYS LATER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L4-5 INTRA-OP CASE. REGISTRATION NORMAL/NO ERRORS/NO SHIFTS. SCREW PLACEMENT: L4-R PLACED, SELECTED L5-R, PRESSED FOOT PEDAL, EE CAME OFF L4-R LIKE NORMAL. MOVED EE OUT OF WAY WITH RING. ADJUSTED L5-R PLAN, BACK TO NAVIGATE, PRESSED FOOT PEDAL, ARM FLOATED TO THE SIDE. THEN ARM LOCKED UP/WOULD NOT MOVE VIA BUTTONS, FOOT PEDAL, OR RING. ARM WOULD NOT MOVE, RE-HOME, OR RE-CALIBRATE LOADCELL AFTER MULTIPLE HARD SHUTDOWNS AND SOFTWARE RESETS.

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 THAT THE MONOPOLAR ENERGY WAS NOT WORKING. THE SITE KEPT GETTING MESSAGES TO CHECK THE MONOPOLAR ENERGY CORD, THE INSTRUMENT TIP, AND/OR SHEATH. THE SITE TRIED THREE DIFFERENT ENERGY CORDS, THREE INSTRUMENTS, THREE TIPS, AND TWO SHEATHS, ALL WITH DIFFERENT MESSAGES AND NO MONOPOLAR ENERGY. THE SITE DID A POWER CYCLE OF THE SYSTEM, AND VISION SIDE CART (VSC) BREAKER, WITH NO CHANGE. THE SITE HAD AN ORANGE INSTRUMENT CORD LED ON THE ENERGY SHIELD CONSTANTLY. THE SITE RESEATED THE CORD FROM THE ENERGY SHIELD TO THE ERBE GENERATOR WITH NO CHANGE. THE SITE SWAPPED OUT THE SYSTEM FOR AN XI SYSTEM AND ENDED THE CALL. THERE WERE NO REPORTS OF PATIENT INJURY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 3/27 A CASE WITH DR.(B)(6). 4 SCREWS PLACED ROBOTICALLY USING CREO MIS AND INTRA-OP CT SCAN WITH EXCELISIUS360. CT SCAN AND ROBOTIC PLACEMENT WENT WELL. AFTER SCREWS IN, I BELIEVE LL5 SCREW WAS PLACED TOO ANTERIOR TO PLAN. NO ADVERSE EFFECTS TO PT, SCREW WAS BACKED OFF A FEW MM. SURGEON DOES WANT TO USE ROBOT UNTIL ISSUE IS RESOLVED/ FIGURE OUT WHAT WENT WRONG. CASE LONGS HAVE BEEN SUBMITTED TO IN TEAM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS CASE WAS PERC SCREWS AT T11-L3, SKIPPED L1. WE USED E3D AS INTRA OP SCAN WITH AUTOMATIC REGISTRATION. T11 - T12 SCREWS WERE PLACED FIRST, UPON THESE SCREWS BEING PLACED IT WAS NOTICED THERE WAS SIGNIFICANT DEFLECTION, IT WAS THEN DETERMINED TO UTILIZE THE TAP FOR THE REMAINING SCREWS, T12 R (THE LAST THORACIC SCREW) - L3 (WHICH WERE ALL PLACED TO PLAN). WE DECIDED TO SPIN AND WE CONNECTED TO ROBOT INCASE ANY SCREWS NEEDED REDONE. UPON SPINNING AFTER ALL SCREWS WERE PLACED, 2 SCREWS WERE MISSED T12 L (MEDIAL) AND T11 R (LATERAL). WE USED THE NEW REGISTRATION TO REPLACE BOTH SCREWS, T12 L WAS REPLACED EXACTLY TO PLAN, BUT T11 R WAS OFF PLAN (MEDIAL) AFTER TAKING A FINAL SPIN TO CONFIRM FINAL PLACEMENT. PLEASE ADVISE AS TO WHY SCREWS WERE MISSED.

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 PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER RECEIVED ERROR 86. THE CUSTOMER POWERED CYCLED THE SYSTEM AND ERROR COME BACK. ONSITE WAS NOT FUNCTIONAL DUE TO BROKEN CABLE/CONNECTOR IN THE OPERATING ROOM (OR). THE CUSTOMER WAS ABLE TO PROVIDE INFORMATION REGARDING ROOT CAUSE; THE NODE INVOLVED WAS 32 AND IT WAS POINTING TO THE ICC BOARD AND/OR POWER SUPPLY. THE PROCEDURE WAS ABORTED POST ANESTHESIA AND PORT PLACEMENT WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE 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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER REPOSITIONING THE ROBOT INTO THE FIELD AND MOVING TO S1L A DRILL WAS PLACED DOWN THE EE. THE OFFSET WAS FULLY RED AS THE INSTRUMENT PASSED DOWN THE EE. DRILL WAS REMOVED, AND EE RESETTLED TO GREEN BORDERS AGAIN. AGAIN, THE DRILL WAS PLACED THROUGH THE EE, AND OFFSET WAS FULLY RED. THE ARRAY ON THE DRILL WAS MOVED, SURGEON ADJUSTED THE DRILL BATTERY TO REDISTRIBUTE THE WEIGHT, AND IT STAYED RED. SURGEON REQUESTED THE ROBOT BE PULLED FROM THE FIELD, AND THE CASE WAS FINISHED WITH STEALTH NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS PERFORMED AS AN OPEN, FOR L2-S2 CONSTRUCT. DUE TO THE INABILITY TO GET THE BOTTOM HALF OF THE PELVIS IN ONE INTRA-OP SPIN USING O-ARM, CASE WAS EXECUTED USING 2 SPINS/CASES/MERGES, BUT SAME DRB/SURVEILLANCE MARKER PLACEMENT FOR EACH CASE. PATIENT WAS POSITIONED PRONE THROUGHOUT THE ENTIRETY OF THE CASE. DRB WAS PLACED IN PATIENT RIDE SIDE PSIS AND SURVEILLANCE MARKER WAS PLACED IN PATIENT'S LEFT SIDE PSIS. WE PROCEEDED WITH OUR TWO PINS FOR OUR PREOP WORKFLOW. SCREWS WERE PLANNED FOR OUR FIRST CASE AS L2-S1 AND WERE CHECKED/CONFIRMED BY DR. (B)(6). SCREWS WERE PLANNED FOR OUR SECOND CASE AS L5-S2 AND WERE CHECKED/CONFIRMED BY DR. (B)(6), AGAIN. WE INITIALLY MERGED OUR FIRST CASE AND EXECUTED PUTTING SCREWS IN AT LEVELS L2-S1. THESE SCREWS ALL WENT IN GREAT AND LOOKED SPOT ON OUR FINAL X-RAYS. WE THEN PROCEEDED WITH OUR SECOND CASE MERGING LEVELS L5-S2. THIS CASE WAS ONLY USED TO PUT IN S2AI SCREWS. WE WERE ABLE TO GET A SUCCESSFUL MERGE AND THEN PROCEEDED WITH PUTTING IN S2AI SCREWS. DR. (B)(6) WAS WORKING FROM PATIENT'S RIGHT SIDE, SO WAS ABLE TO PUT PATIENT'S LEFT SIDED SCREW IN UTILIZING HIGH SPEED BURR, MCS DRILL, TAP, SCREW ON POWER TECHNIQUE WITH EASE. WE THEN PROCEE

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 AT THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, POST-ANESTHESIA AND PORT PLACEMENT, THE SURGICAL TEAM HAD A NON-RECOVERABLE ERROR 86. PRIOR TO CALLING, THE CUSTOMER PERFORMED A REBOOT OF THE VISION SIDE CART (VSC) CIRCUIT BREAKER, BUT THE PROBLEM PERSISTED. THE TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER ABOUT THE ROOT CAUSE FOR THE ISSUE, WHICH WAS A FAULTY POWER BOARD IN THE CORE OF THE VSC. THE SYSTEM WAS NOT USABLE ANYMORE. THE PROCEDURE WAS ABORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED WHEN THE SYSTEM WAS POWERED ON AND THE SYSTEM STARTED WITHOUT PROBLEMS, THE STERILE COVERING OF THE ARMS WAS PERFORMED WITHOUT ISSUES, AND THERE WERE NO ERROR MESSAGES. OPEN SURGERY WAS NOT PERFORMED, THE SURGERY WAS CANCELLED. THE FIRST TROCAR WAS ALREADY PLACED, THEN SUDDENLY THE ERROR MESSAGE APPEARED. IT WAS A SUDDEN OCCURRENCE OF THE ERROR MESSAGE WITHOUT PREVIOUS USE OF THE ROBOT, AS ONLY THE OPTICS WERE USED MANUALLY. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT WAS SCHEDULED FOR ROBOTIC-ASSISTED RADICAL PROSTATECTOMY. THE TE

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 ROBOT IS HAVING SOME PROBLEMS. THE SOFTWARE HAS BEEN EXTREMELY SLOW, VARIOUS GLITCHES WHILE OPERATING, MERGING HAS GOTTEN INCREASINGLY MORE DIFFICULT, AND SCORES KEEP GOING DOWN WITH BOTH PREOP CT AND O-ARM SPINS. THE LAST TWO CASES WE'VE HAD SCREWS PLACED IN AREAS NOT PLANNED BUT LUCKILY THE SURGEON DIDN'T FEEL RIGHT SO HE STOPPED AND DID IT BY HAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GPS WAS UNABLE TO LOAD INTRO-OP SPIN TO GENERATE THE STUDY. A SCAN WAS DONE WITH THE O-ARM AND WAS SAVED ON 2 DIFFERENT USB DRIVES, TRYING BOTH USB PORTS ON THE GPS WITH THE SAME RESULT. THE STATUS BAR WAS STALLING/FREEZING AT ABOUT 85%. WE HAD TO HOLD DOWN THE POWER BUTTON TO POWER CYCLE THE GPS TO GET IT UNFROZEN FROM THAT LOADING SCREEN. WE PERFORMED A 2ND SCAN WITH THE O-ARM TO MAKE SURE THE ISSUE WAS NOT WITH THE FIRST STUDY WITH THE SAME RESULTS USING THE SAME METHODS. THE GPS AT ONE POINT WOULD NOT POWER DOWN BY HOLDING DOWN THE POWER BUTTON BUT EVENTUALLY DID. DURING THE REBOOT OF THE GPS, THE SCREEN REMAINED DARK WITH RED STATUS LIGHT ON 2 DIFFERENT OCCASIONS AS WELL. DR. (B)(6) WANTS A TECHNICIAN TO COME LOOK AT THIS UNIT AS SOON AS POSSIBLE. HE CANCELED THE CASE AND HAD THE PATIENT WOKEN UP FROM ANESTHESIA DUE TO THIS MALFUNCTION.

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: SCREWS PLANNED ON EGPS UNIT WERE NOT EXECUTED TO PLAN IN PATIENT - SCREWS SHIFTED LATERALLY. COULD YOU PLEASE EVALUATE THE LOGS AS WE HAD SIGNIFICANT SHIFT ON SCREW VS PLAN ON TIS 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA REPAIR PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT FELL OFF INSIDE THE PATIENT. AT THE TAIL END OF THE DISSECTION OF THE LESSER BLOOD SUPPLY ALONG THE GREATER CURVATURE OF THE STOMACH, THE SYSTEM ASKED FOR THE SURGEON TO RELEASE TENSION/PRESSURE FROM THE INSTRUMENT AND REAPPLY THE INSTRUMENT. THE SURGEON DID AS THE SYSTEM INSTRUCTED. WHEN THE SURGEON STARTED DISSECTING AGAIN THE WARNING REAPPEARED. THE SURGEON ONCE AGAIN DID AS THE SYSTEM INSTRUCTED. AS THE SURGEON WENT IN TO GRAB THE TISSUE FOR A THIRD TIME, THE MOBILE BLADE OF THE INSTRUMENT FELL OFF. THE INSTRUMENT WAS REMOVED AND REPLACED. THE INSTRUMENT FRAGMENT/PIECE WAS FOUND AND REMOVED SAFETY FROM THE PATIENT'S ABDOMINAL CAVITY. 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: IT WAS CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS SEEN. THE SURGEON BELIEVE IT WAS CAUSED BY A FAULTY BUILD. THE INSTRUMENT BROKE ROUGHLY THREE QUARTERS OF THE WAY THROUGH THE CASE. NO ISSUES WERE SEEN WITH THE FUNCTIONALITY

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) DID A REVISION L1-S1 TODAY AT THE SURGERY CENTER USING E3D AND EGPS. THE PT WAS DRAPED AND THE DRB WAS PLACED IN THE RIGHT PSIS, AND WAS MARKED USING A SKIN MARKER. WE PROCEEDED WITH AN E3D SPIN AND TRANSFERRED THE INTRA-OP CT TO EGPS. THE PT WAS THEN EXPOSED, INSTRUMENTATION WAS REMOVED AND WE CONTINUED WITH THE EGPS SYSTEM PUTTING IN SCREWS. WE GOT TO L5 AND THE DRB WAS BUMPED AND ROTATED, AT WHICH POINT WE ABORTED TO ROBOT AND FREE HANDED SCREWS AT S1. X-RAYS WERE TAKEN OF THE SCREWS PLACED, RIGHT L1 AND L2 WERE LATERAL, AND THE SURGEON REPLACED THEM FREE HAND. LEFT L1 WAS DETERMINED TO BE TOO MEDIAL AND WAS ALSO REPLACED. THE REMAINING SCREWS WERE CHECKED VIA FLUORO SHOTS AND WERE CONFIRMED TO BE PLACED ADEQUATELY.

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 AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN WHILE GRASPING TISSUE. THE INSTRUMENT FRAGMENTS FELL INSIDE THE PATIENT¿S CAVITY AND WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO BLEEDING. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. 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: DURING THE PROCEDURE, THE INSTRUMENT TIP WAS FOUND BROKEN ON THE CAMERA SCREEN AFTER USING THE INSTRUMENT FOR ABOUT 10 MINUTES. ALL THE FRACTURED PARTS WERE FOUND, RETRIEVED, CONFIRMED TO BE INTACT BY PUTTING THE PIECES TOGETHER, AND THERE WAS NO RESIDUE IN THE FIELD OF VIEW. THE SURGEON BELIEVED THERE WAS AN INSTRUMENT COLLISION DURING THE CASE BUT THE ISSUE WAS DUE TO INSTRUMENT QUALITY. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). NO FUNCTIONAL ISSUES WERE FOUND. UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT'S WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON

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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, SYSTEM GENERATED A NON-RECOVERABLE FAULT 297. PRIOR TO CALLING TECH SUPPORT THE CUSTOMER TRIED TO RESTART SYSTEM SEVERAL TIMES WITHOUT SUCCESS. THE ERROR KEPT ON TRIGGERING. SURGEON DECIDED TO CONVERT TO OPEN SURGERY. TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS THAT WERE SHOWING REPEATED NON-RECOVERABLE FAULT 297 POINTING TO AUXILIARY VIDEO BOARD (AVP)3. TSE CONNECTED TO SYSTEM TO DISABLE AVP3 NODE, BUT WHEN USER RESTARTED SYSTEM IN NORMAL MODE THERE WAS NON-RECOVERABLE FAULT 40019, THAT MAY INDICATE THAT THE MODIFICATION IN DOWNLOAD APP DID NOT GO WELL. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGERY WAS NOT PERFORMED WITH A ROBOTIC APPROACH BECAUSE THE FAILURE WAS NOT RECOVERED BEFORE SURGERY STARTED. THEREFORE, IT WAS DECIDED THAT THE SAFEST APPROACH FOR THE PATIENT, SINCE IT WAS A COMPLEX CASE IN WHICH THE ROBOT COULD HELP, WAS OPEN SURGERY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) PLANNED TO PLACE SCREWS AT L3-4 BILATERALLY, HE DID A MIDLINE INCISION AND PERFORMED LAMINECTOMY AT L3, AND DECOMPRESSION AT BOTH LEVELS. AFTER DECOMPRESSION COMPLETED AND SURGEON HAPPY WITH IT, WE PLACED SP CLAMP ON L5 SPINOUS PROCESS. DRB WAS PLACED AND WE WENT TO TAKE SHOTS. WE SUCCESSFUL MERGED L3 AND L4. ALL 4 SCREWS WERE PLACED USING WORKFLOW HIGH SPEED DRILL, 3.5 DRILL THEN SCREW PLACED. WE TOOK A SHOTS TO CONFIRM SCREW PLACEMENT, ON AP WE SAW OUR FIRST SCREW LEFT L3 WAS BREACHED LATERALLY. THE OTHER 3 SCREWS WERE PLACED TO PLAN. WE DIDN'T NOTICE INSTRUMENTS GOING LATERALLY WHEN PREPARING HOLE FOR SCREW. SCREW WAS REMOVED AND WE MADE SURGEON NAVIGATION WAS STILL ACCURATE. WE WENT TO PLACE SCREW AGAIN, USING HIGH SPEED BURR, AND 3.5 DRILL, PLACED SCREW. AGAIN, IT WAS BREACHED LATERALLY. WE REMOVED BOTH LEFT SIDE SCREWS AND JUST PLACED ROD AND LOCKING NUTS ON RIGHT SIDE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE MERGE OF OUR CASE, THE SI JOINT LEVELS WOULD NOT POPULATE AFTER THE MERGE. CREO SCREWS WERE PLANNED AT 5-1 AND ADJUSTED TO 4-1 DURING OTHER ATTEMPTS. SI-LOK WAS PLANNED BILATERALLY. ALL NEW IMAGES WERE TRIED FIRST. THEN, A NEW CASE WITH NEW IMAGES WAS TRIED AS WELL. SOFTWARE RESET, HARD SHUT DOWN, CRANIAL AND BACK WERE TRIED AS WELL. THIS ACCOUNT HAS BEEN REGULARLY DOING SI-LOK CASES WITH NO ISSUES. THE MERGE WAS SUCCESSFUL AT L4-S1. MULTIPLE CSR'S WERE CALLED ALONG WITH OTHER MEMBERS OF THE TEAM UNABLE TO DISCERN THE ISSUE. THE CASE WAS UNABLE TO BE COMPLETED AND THE OPERATION WAS DONE UNDER 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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE COULD NO LONGER BE ROTATED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, WITH A BACKUP ENDOSCOPE, AND WITH A DELAY OF 50 MINUTES. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT UNDERWENT DA-VINCI ASSISTED LOBECTOMY ON (B)(6) 2023 AS PART OF THE CGMH SP CLINICAL STUDY. ON (B)(6) 2023, THE PATIENT DEVELOPED CHYLOTHORAX WITH HIGH TRIGLYCERIDES (TG) AND REQUIRED PROLONGED HOSPITALIZATION. DIET CONTROL WAS IMPLEMENTED INCLUDING KABIVEN (TOTAL PARENTERAL NUTRITION) ADMINISTERED ON (B)(6) 2023 FOR TWO DAYS. THE PATIENT WAS STARTED CLEAR LIQUID DIET ON (B)(6) 2023 AND STARTED NON-FAT DIET ON (B)(6) 2023. THE PATIENT`S CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE STUDY INVESTIGATOR ASSESSED THE REPORTED EVENT AS TO NOT RELATED TO THE DV SYSTEM, INSTRUMENTS OR ACCESSORIES, NOT RELATED TO THE DV ASSISTED SURGERY. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

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 1ST CASE OF THE DAY (PATIENT IN THE ROOM UNDER ANESTHESIA) PHYSICIAN REPORTED PNEUMOTHORAX. SYSTEM INITIALIZED CORRECTLY, SETUP AND SCOPE REGISTRATION HAD NO ISSUES. WHEN NAVIGATING TO THE TARGET IN LEFT LOWER LOBE, 100MM FROM THE TARGET, THE PHYSICIAN BACKED OUT ALL THE WAY TO MAIN CARINA AND WENT BACK WITHOUT RE-REGISTERING THE SCOPE. THE PHYSICIAN WAS MOVING BACK AND FORTH, WAS FOLLOWING FLUORO, AND IT WAS AT THIS POINT THEY NOTED THE PNEUMOTHORAX. THE PHYSICIAN FEELS THE MONARCH CAUSED THE PNEUMOTHORAX, CONVERTED TO MANUAL SCOPE, AND SUCCESSFULLY COMPLETED THE CASE. A CHEST TUBE WAS PLACED, AND THE PATIENT DISCHARGED THE SAME DAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE FLOW: PATIENT WAS PREPPED AND POSITIONED PER STANDARD MEANS AND SCOUT SHOTS OF LUMBAR ANATOMY WAS TAKEN VIA X-RAY AND VERTEBRAL MARKS PLACED ON SKIN. DR. (B)(6) THEN EXPOSED L1 AND L2 PLACING THE SPINOUS PROCESS CLAMPS FOR THE DRB (ON L2) AND ICT/ SURVEILLANCE MARKER (SM) (ON L1). SM WAS REGISTERED AND THE O-ARM BROUGHT INTO POSITION AT TABLE. P/A, LAT, AND A/P SCOUT SHOTS WERE TAKEN TO ENSURE CORRECT LEVELS AND ICT FRAME FIDUCIALS WERE VISUALIZED FOR THE SPIN. SOME ADJUSTMENTS TO THE ICT FRAME AND PIVOT ARM WERE MADE TO ENSURE THAT EVERYTHING WAS ALIGNED. AT THIS TIME THE FIELD CAPTURE SNAPSHOT WAS TAKEN, THE ICT/DRB WERE COVERED WITH BLUE STERILE CLOTH, RESPIRATIONS HELD AND A CT SPIN WAS TAKEN. THE SCAN WAS CHECKED TO ENSURE THE ICT AND FIDUCIALS WERE ALL CAPTURED. THE SCAN WAS EXPORTED VIA USB THUMB DRIVE AND TRANSFERRED SUCCESSFULLY TO THE EXCELSIUS GPS WHERE THE REGISTRATION FIT WAS VERY GOOD. THE O-ARM WAS REMOVED FROM THE TABLE, BLUE CLOTH REMOVED, ICT PIVOT ARM REMOVED FROM CLAMP, SM REMOVED TO SLIDE OFF ICT CLAMP AND REPLACED. SKIN LANDMARK CHECKS WERE DONE AND SM WAS RE-REGISTERED. SINCE L1 SPINOUS PROCESS WAS VISIBLE IN THE SCAN AND DIRECT ACCESS WAS POSSIBLE VIA T

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NEXT, AS WE BEGAN NAVIGATING, WE POSITIONED THE ROBOT NEAR THE PATIENT, AND GREEN BOXES APPEARED FOR OUR DESIRED LEVELS SIGNALING THAT TRAJECTORY WAS WITHIN RANGE. STABILIZERS WERE DEPLOYED, A SINGLE LEVEL WAS SELECTED, BUT AS THE SURGEON PRESSED THE FOOT PEDAL, A "TRAJECTORY WAS NOT WITHIN RANGE" WARNING APPEARED. WE ATTEMPTED TO REPOSITION THE ROBOT MULTIPLE TIMES, AND EACH TIME THE WARNING APPEARED. THIS PROHIBITED US FROM PROCEEDING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MISSED S2AI SCREWS BOTH MEDIAL.

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 TONSILLECTOMY SURGICAL PROCEDURE, THE INSTRUMENTS MOVED BACKWARDS WHEN PLACED ON THE ROBOT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER HAD CONVERTED THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY. THE SITE WAS USING A 0-DEGREE ENDOSCOPE WHEN THE ISSUE OCCURRED AND THEY WERE UNSURE IF THEY HAD CAMERA UP OR DOWN SELECTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THE PATIENT TOLERATED THE CONVERSION WELL AND THERE WAS 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: MOTION CONTROL. COMMUNICATION FAILED ERROR. THIS KEEPS POPPING UP.

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 SURGICAL PROCEDURE, A PORTION OF THE HARMONIC ACE INSTRUMENT BROKE OFF DURING USE. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO NOTED DAMAGE. THE INSTRUMENT BROKE RIGHT AT THE JAW HINGE. THE INSTRUMENT WAS IN USE FOR ROUGHLY 10 MINUTES. THE SURGEON DID NOT NOTICE AN ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. THE FRAGMENT FELL INSIDE THE ABDOMEN DURING THE PROCEDURE. THE INSTRUMENT WAS NOT REMOVED PRIOR TO BREAKAGE. THE BREAK WAS NOTICED IMMEDIATELY AS THE SURGEON SAW THE JAW FALL DOWN. THE SURGICAL STAFF GRABBED THE JAW FRAGMENT WITH GRASPERS AND REMOVED FRAGMENT THROUGH AN ASSIST PORT. AN ADDITIONAL SURGICAL PROCEDURE WAS NOT REQUIRED TO REMOVE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO THE 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 THE PATIENT UNDERWENT DA VINCI-ASSISTED SP EXTRAPERITONEAL PROSTATECTOMY ON (B)(6) 2023 AS PART OF THE CGMH URO SP CLINICAL STUDY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2023 WITH ABDOMINAL DISCOMFORT AND SWELLING WITH NO URINE OUTPUT INTO HIS URINARY BAG. THE PHYSICIAN AT THE EMERGENCY ROOM OBSERVED THAT THE PATIENT HAD ABDOMINAL SWELLING, DISCOMFORT IN ABDOMINAL AND GENITAL AREA WITH THE PAIN ASSESSMENT 1 OUT OF 10, AND MILD HEMATURIA. CYSTOGRAPHY AND CT OF UROGRAPHY (CTU) INITIALLY CONFIRMED ASCITES. SUPRAPUBIC CYSTOSTOMY WAS PERFORMED AS TREATMENT. THE STUDY INVESTIGATOR ASSESSED THIS EVENT AS NOT RELATED TO DA-VINCI DEVICES, AND POSSIBLY RELATED TO THE PROCEDURE. INTUITIVE SURGICAL INC (ISI) OBTAINED ADDITIONAL INFORMATION AS THE FOLLOWING: THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOR ANY OTHER POST-OPERATIVE COMPLICATIONS. THERE WERE NO ALLEGATIONS OF ANY MALFUNCTIONS OF ANY DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. THE PATIENT WAS LATER FOUND WITH PERIVESICAL FLUID INSTEAD OF ASCITES VIA CT SCAN. A PIGTAIL DRAIN WAS PLACED. AFTER ADMISSION, CYSTOGRAPHY SHOWED MINIMAL LEA

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 SURGICAL PROCEDURE, ERRORS OCCURRED ON THE HARMONIC ACE INSTRUMENT, AND THE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT AFTER TEN MINUTES INTO THE OPERATION. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE HARMONIC ACE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUE WAS NOTED. THE HARMONIC ACE INSTRUMENT PERFORMED AS INTENDED UP UNTIL IT BROKE WHILE THE SURGEON WAS DISSECTING UNSPECIFIED TISSUE. THE HARMONIC ACE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. AFTER THE HARMONIC ACE BLADE BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS VISUALLY LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER CONFIRMED ALL FRAGMENTS WERE RETRIEVED BY MATCHING THE BROKEN FRAGMENT TO THE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE WAS 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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE SURGICAL STAFF OBSERVED INVERTED IMAGING WHILE USING A 30 DEGREE ENDOSCOPE PLUS. THE ISSUE OCCURRED ONCE DURING THE PROCEDURE. THE SURGEON INDICATED THAT THE ENDOSCOPE MOVED WITH UNINTUITIVE MOVEMENTS AND WITH REVERSED CONTROL DESPITE CORRECT ALIGNMENT AND INSTALLATION. THE ENDOSCOPE WAS PULLED OUT OF THE PATIENT SIDE CART (PSC) AND RESEATED WHICH SUCCESSFULLY CLEARED THE ISSUE. PER THE SURGEON, THERE WAS A "PROLONGATION OF THE PROCEDURE" BY 15 MINUTES AND "MINIMALLY INCREASED BLOOD LOSS, BUT NO LASTING HARM." THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE EVENT IS UNKNOWN. IN ADDITION, THE SOURCE OF THE BLEEDING AND WHAT MEDICAL INTERVENTION, IF ANY, WAS RENDERED DUE TO THE COMPLICATION ARE UNKNOWN AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AFTER PROCEDURE COMPLETION AND FOUND AN ERROR POINTING TO A SCOPE ENGAGEMENT ISSUE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE INFO: DR. (B)(6). L4-S2AI CORTICAL TRAJECTORY OPEN FUSION. 1.1R4 EGPS SOFTWARE. SETUP; DR. (B)(6)' PA, DAMIEN, IMPLANTED THE DRB VIA THE QUATTRO SPIKE INTO THE RIGHT PSIS. (B)(6) THEN IMPLANTED THE SM IN THE LEFT PSIS. EGPS POSITIONED ON THE SAME SIDE AS DAMIEN AND THE C-ARM OPPOSITE THE OR DOOR. CAMERA WAS POSITIONED AT THE FOOT OF THE BED. EXTRA MONITOR FROM SSI USED FOR DR. (B)(6) DURING REGISTRATION THEN FOR (B)(6) FOR SCREW PLACEMENT. (B)(6) THEN VERIFIED SURVEILLANCE. REGISTRATION; THE REGISTRATION TOOK 5 MINUTES. AFTER A SUCCESSFUL MERGE, (B)(6) COMPLETED A LANDMARK CHECK. IMPLANTATION; (B)(6) IMPLANTED EACH SCREW USING; FIRST, THE 4.5 HS DRILL/3.5 TIPPED DRILL, FOLLOWED BY THE SCREW- EVENTUALLY SKIPPING THE 4.5MM HS DRILL. SCREW PLACEMENT FROM L4-S1 TOOK 10 MINUTES. FOR S2AI IT TOOK 30 MINUTES. DR. (B)(6) USED THE TIPPED 5.0/6.0MM CREO MCS DRILL WITH THE 60MM HARD STOP THEN USED A TAP TO GET ACROSS THE JOINT. S2AIL IMPLANTATION WAS SUCCESSFUL BUT S2AIR BREACHED ANTERIORLY. ***WE BELIEVE THAT THE STARTING POSITION FOR S2AIR BEING MORE INFERIOR (PLANNED BELOW 3X SI-BONE SCREWS) THE SI JOINT WAS FURTHER THAN THE HARD STOP PREVENTING THE TIPPED DRILL FROM SUCCESSFULLY CROS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE HOSPITAL JUST PURCHASED TWO NEW CT MACHINES AND HAS A SLIGHT TURNOVER OF CT TECH STAFF. THE FIRST SCAN LOADED ONTO THE ROBOT WITH A YELLOW WARNING. I CLICKED THROUGH IT NOT THINKING TWICE BECAUSE THE SCAN POPULATED ON THE IMAGE LOCAL PAGE/ALLOWED ME TO PROCEED TO PLAN. WHEN REGISTERING THE X-RAYS TO THE SCAN (PREP CUT WORKFLOW), THE ERROR "FLUORO-CT IMAGE REGISTRATION FAILED" IN YELLOW POPULATED THE SCREEN. I TRIED RESETTING THE SOFTWARE, RESTARTING THE ROBOT, EVEN CHANGING THE SCAN TO ANOTHER ONE TITLED "THINS" (INSTEAD OF THE PRESET "GLOBUS 1MM BY 1MM") AND RE-REGISTERING. NOTHING WORKED, AND THE SURGEON ENDED UP BAILING ON THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: POWER NOT GETTING TO ROBOT. APPEARS TO BE A FUSE ISSUE.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY DID NOT WORK. A FRAGMENT FROM AN UNSPECIFIED LOCATION OF THE INSTRUMENT ALLEGEDLY FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO FRAGMENT LEFT.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX, HEMOPTYSIS, AND DYSPNEA. A PIGTAIL (CHEST TUBE) WAS PLACED AND THE PATIENT WAS HOSPITALIZED AND LATER RELEASED. NO MALFUNCTION, FAULT OR ERRORS WERE REPORTED.

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 PORT PLACEMENT BUT PRIOR TO DOCKING FOR A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SITE WAS HAVING ISSUES WITH ENDOSCOPE ENGAGEMENT. PRIOR TO CALLING IN, INTUITIVE REP HAD THE STAFF RE-DRAPE TWICE AND TRY TWO DIFFERENT ENDOSCOPES. TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE REP THROUGH A HARD POWER CYCLE OF THE PATIENT SIDE CART (PSC) AND REINSTALLATION OF CAMERA ARM STERILE ADAPTER. TSE RECOMMENDED CUSTOMER ATTEMPT A THIRD ENDOSCOPE, BUT SYSTEM WOULD NOT ACCEPT THE THIRD ENDOSCOPE. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CONFIRMED THAT PORTS WERE PLACED. THEY WERE PREPARING TO DOCK AND ENTER DIRECTLY INTO THE BLADDER. THEY CUT FACIA AND ENTERED DIRECTLY INTO THE BLADDER. THE REST OF THE INSTRUMENTS WERE DOCKED, BUT THE NONE OF THE ENDOSCOPES WOULD ENGAGE. CONFIRMED THERE WERE NO POST-OP COMPLICATIONS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PATIENT WAS ADMITTED FOR IN-PATIENT HOSPITALIZATION. SUPPLEMENTAL OXYGEN WAS ADMINISTERED. THE PATIENT WAS RELEASED TWO (2) DAYS LATER. THE HOSPITAL CLINICAL RESEARCH COORDINATOR REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE. AFTER THE PROCEDURE, THE PATIENT REPORTED HAEMOPTYSIS. THE PATIENT¿S HAEMOPTYSIS WAS REPORTED AS POSSIBLY RELATED TO USE OF THE MONARCH SYSTEM. THE PATIENT¿S SYMPTOM WAS REPORTED AS HAVING A CAUSAL RELATIONSHIP TO THE BRONCHOSCOPY PROCEDURE. THE HAEMOPTYSIS WAS REPORTED AS RESOLVED WITHOUT SEQUALAE. IN ADDITION, THE PATIENT REPORTED SHORTNESS OF BREATH. THE PATIENT¿S SHORTNESS OF BREATH WAS REPORTED AS NOT RELATED TO USE OF THE MONARCH SYSTEM. HOWEVER, THE PATIENT¿S SYMPTOM WAS REPORTED AS POSSIBLY RELATED TO THE BRONCHOSCOPY PROCEDURE. ON FEBRUARY 17, 2023, THE PATIENT¿S SHORTNESS OF BREATH WAS REPORTED AS RESOLVED WITHOUT SEQUALAE. THERE WAS NO REPORTED MALFUNCTION OF THE MONARCH BRONCHOSCOPY SYSTEM.

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 DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT HAD A PIECE OF METAL THAT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL REPORTED INJURY. INTUITIVE SURGICAL, INC. (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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE THAT THE BIPOLAR ENERGY WAS NOT WORKING. THE STAFF TRIED TWO DIFFERENT BIPOLAR INSTRUMENT CORDS BEFORE CALLING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE STAFF TO CYCLE THE ERBE GENERATOR POWER. THE SURGEON CONVERTED TO AN OPEN PROCEDURE. 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: DR. (B)(6) FIRST DBS PROCEDURE WITH EGPS AND E3D HAD TO BE ABORTED DUE TO MISSED TRAJECTORIES, THAT IS BELIEVED TO BE DUE TO MERGE ISSUES WITH THE PRE-OP T1 MRI. THE PATIENT WAS ATTACHED TO THE PSS WITH A LEKSELL HEAD-FRAME, AND A THE LEKSELL FRA WAS USED FOR REFERENCE. A NON-STERILE INTRAOP REGISTRATION WAS PERFORMED WITH E3D AND LANDMARKS WERE CHECKED SHOWING AN ACCURATE REGISTRATION. THE PATIENT WAS PREPPED AND DRAPED AND INCISION AND BURR-HOLES WERE MADE. THE ROBOT WAS BROUGHT BACK INTO POSITION AND A THIRD LANDMARK VERIFICATION WAS PERFORMED, A TEST TRAJECTORY WAS SET UP AND THE ROBOT SHOWED ACCURATE PLACEMENT. THE ROBOT WAS SENT TO THE LEFT GPI TRAJECTORY AND THE LEAD WAS PLACED. A STERILE EVALUATION SPIN WAS COMPLETED WITH E3D AND SHOWED AN ANTERIOR TO POSTERIOR LEAD PLACEMENT, BISECTING THE INTENDED TRAJECTORY. LANDMARK CHECKS WERE PERFORMED AGAIN SHOWING A SLIGHTLY DEEP INSTRUMENT IN THE CT SCAN. IT WAS ALSO NOTICED THAT THE ALPHA OMEGA XY BASE STAGE WAS LOOSE AND ROCKING BACK AND FORTH. IT WAS DECIDED TO RE-REGISTER THE PATIENT WHICH WAS SUCCESSFULLY PERFORMED. LANDMARK CHECKS SHOWED AN ACCURATE REGISTRATION. THE ROBOT WAS SENT BACK TO THE TRAJECTORY AND THE LEAD WAS REPL

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 PROCEDURE, THE PATIENT'S VAS DEFERENS WAS INJURED. THE ISSUE OCCURRED DURING THE END OF THE PROCEDURE WHILE PERFORMING THE ANASTOMOSIS. THE SURGEON ROTATED THE 0 DEGREE ENDOSCOPE PLUS SEVERAL TIMES WHILE LOOKING FOR A SUTURE NEEDLE, AFTER WHICH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ALLEGEDLY WENT OUT OF CONTROL TOWARDS THE VAS DEFERENS AND UNINTENTIONALLY TRANSECTED IT. IT IS UNCLEAR IF THE VAS DEFERENS WAS REPAIRED. THE ARTERY AND VEIN NEXT TO THE VAS DEFERENS DID NOT CONTACT THE MCS AND WERE THEREFORE NOT INJURED. WHILE ROTATING THE ENDOSCOPE, AN UNSPECIFIED ¿BAD SOUND¿ WAS HEARD. NO ERROR MESSAGE DISPLAYED. ALL THE INSTRUMENTS WERE THEN REMOVED FROM THEIR RESPECTIVE UNIVERSAL SURGICAL MANIPULATORS (USM)S AND REINSTALLED. THE SURGICAL STAFF THEN CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN 8MM 30 DEGREE ENDOSCOPE. THE SURGEON BELIEVES THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION WAS DUE TO A PROBLEM WITH THE 0 DEGREE ENDOSCOPE PLUS FOLLOWED BY FEELING UNEXPECTED MOVEMENTS WITH THE USMS. THE PATIENT DID NOT EXPERIENCE POST-OPERATIVE COMPLICATIONS AND WAS REPORTED TO BE ¿OKAY¿. THE INTU

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 AS PART OF A CLINICAL TRIAL THAT 2 DAYS AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME), THE PATIENT EXPERIENCED LIGHTHEADEDNESS WITH NAUSEA AND VOMITING. A NASOGASTRIC WAS PLACED, AND ILEUS WAS SHOWN ON X-RAY. BLOOD WORK SHOWED NO CONCERNS OF BLEEDING OR INFECTION. IV FLUIDS WERE GIVEN TO THE PATIENT. NO MALFUNCTIONS OF SP SYSTEM OR INSTRUMENTS WERE REPORTED, AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE SURGERY. ON POST-OPERATIVE DAY (POD) #5, THE PATIENT WAS REPORTED RESOLVED FROM ILEUS. THE PATIENT WAS DISCHARGED ON POD #6 WITH NORMAL BOWEL FUNCTION AND WAS TOLERATING A GENERAL DIET.