Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY THE SALES REP "ON 18MAY23 THE SURGEON WAS SHOWN THE POST-OP X-RAY THAT HAS ANTERIOR NOTCHING FROM MAKO RIGHT TKA ON (B)(6) 2023. THE PATIENT CAN NOT FULL WAIT BEARING".

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

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 INTRA-OPERATIVELY. IT WAS REPORTED THAT DURING A CASE THE L2-S1 ON THE LEFT AND THOSE SCREWS WERE PLACED FINE. RIGHT L2 WAS MEDIAL WHEN THEY DRILLED AND NOTICED CSF. THEY SPUN L1-T10 AND PROCEED TO DO THOSE WITH THE GUIDANCE SYSTEM. THE SURGEON WENT BACK TO DO L2-S1 WITH THE C-ARM. THERE WAS A DELAY OF LESS THAN 1 HOUR. THE PATIENT DID NOT EXPERIENCE ANY SYMPYOMS DUE TO THE CSF LEAK. THE CAUSE OR SUSPECTED CAUSE OF THE DEVIATION WAS STATED TO BE DUE TO SKIVING. TRAJECTORIES WERE DEVIATED LESS THAN 3.5 MM.

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

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 DURING THE SCAN & PLAN CASE. THEY PLANNED THE SCREWS, TAPPED ALL TRAJECTORIES, DRILLED THE PILOT HOLES, AND INSERTED THE SCREWS. THE SURGEON STATED THAT EVERYTHING FELT GOOD DURING THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE SAID THE IMAGES INDICATED LATERAL ON THE LEFT SIDE AND MEDIAL ON THE RIGHT. THE SCOPE OF THE SURGERY WAS FOUR TRAJECTORIES ON L4 AND L5. ALL FOUR TRAJECTORIES LOOKED OFF POST-OP. DELAY WAS APPROXIMATELY 30 MINUTES. THERE WAS NO REPORTED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS IN THE FOOT OR TOES. THE NUMBNESS WAS NOT TEMPORARY. NUMBNESS IS IN THE RIGHT FOOT. THE SURGEON DECIDED TO REVISE RIGHT SIDE L4-5 PEDICLE SCREWS. HE REMOVED AND REPLACED THEM PERCUTANEOUSLY WITH FLUOROSCOPY ON (B)(6) 2023. AT THE TIME OF THE ORIGINAL CASE THE TRAJECTORIES WERE DEVIATED APPROXIMATELY 7MM LOW AND LEFT OF THE PLANNED TRAJECTORIES.

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: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI-ASSISTED ROBOTIC PROCEDURES TITLED, ¿SINGLE PORT VERSUS MULTIPORT ROBOT-ASSISTED SIMPLE PROSTATECTOMY: A MULTI-INSTITUTIONAL STUDY FROM THE SINGLE-PORT ADVANCED RESEARCH CONSORTIUM (SPARC)¿ THE FOLLOWING EVENTS WERE REPORTED. A MULTI-INSTITUTIONAL STUDY EVALUATED AND COMPARED 405 PATIENTS WHO UNDERWENT DA VINCI ROBOTIC-ASSISTED SINGLE PORT (SP) AND MULTIPORT (MP) SIMPLE PROSTATECTOMY BETWEEN JANUARY 2017 AND OCTOBER 2022. AMONG THOSE PATIENTS, 249 UNDERWENT PROCEDURES USING THE MULTIPORT DAVINCI XI SYSTEM, AND 156 UNDERWENT PROCEDURES USING THE SINGLE PORT DAVINCI SP SYSTEM. THERE WERE 5 PATIENTS WITH INTRAOPERATIVE COMPLICATIONS ASSOCIATED WITH THE USE OF THE SINGLE PORT DA VINCI SP SYSTEMS. FOUR OF THE PATIENTS EXPERIENCED AIR EMBOLI, AND ONE PATIENT EXPERIENCED A POSTERIOR CYSTOTOMY. OTHER THAN THE 4 AIR EMBOLI AND 1 POSTERIOR CYSTOTOMY, THE ARTICLE DOES NOT PROVIDE ANY SPECIFIC INFORMATION ON THE NATURE OR SEVERITY OF THE COMPLICATIONS OTHER THAN THE TABLE 2 CLAVIEN-DINDO CLASSIFICATIONS WHICH DOCUMENTS THE FOLLOWING: GRADE I: 6 EVENTS / GRADE II: 5 EVENTS / GRADE IVA: 1 EVENT. COMPLICATIONS ENCOUNTERED FOR THE PROCEDURES

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

Mazor X — Death 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 MANUFACTURER REPRESENTATIVE WAS SETTING UP FOR A CASE WHEN THE PATIENT PASSED AWAY WHILE THE SURGEON WAS DOING THE INTERBODY PLACEMENT PORTION OF THE PROCEDURE. THE REPRESENTATIVE HAD TURNED THE SYSTEM ON AND ENTERED THE KIT CODE IN PREPARATION FOR ITS USE. THE SYSTEM WAS NOT MOUNTED TO THE BED. NO MEDTRONIC HARDWARE OR EQUIPMENT WAS USED PRIOR TO THE PATIENT PASSING AWAY. THE PROCEDURE WAS NO DELAYED.

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.

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 REVIEW OF THE ARTICLE WAS CONDUCTED WHICH EVALUATED THE ONCOLOGICAL AND FUNCTIONAL OUTCOMES OF ZERO ISCHEMIA ROBOTIC PARTIAL NEPHRECTOMY (RPN). THIS MULTICENTER PROSPECTIVE STUDY ANALYZED 56 PATIENTS WHO UNDERWENT ZERO ISCHEMIA RPN BETWEEN 2013 AND 2021. ONE PATIENT EXPERIENCED PERIOPERATIVE COMPLICATION OF MAJOR HEMORRHAGE REQUIRING BLOOD TRANSFUSION AND ANGIOGRAPHIC INTERVENTION. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. THE CORRESPONDING AUTHOR WAS CONTACTED BUT NO RESPONSE HAS BEEN RECEIVED.

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

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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT THERE WAS NO EFFECT TO THE PATIENT AS THEY COMPLETED THE CASE AND REPORTED THE COMPLAINT THE DAY OF THE SURGERY. THE PATIENT DID NOT EXHIBIT ISSUES UNTIL LATER IN POST-OP.THE PATIENT WAS HAVING WEAKNESS IN ONE LEG WITH SOME DIFFICULTY WALKING. AT THE TIME OF THE CASE NEUROMONITORING WAS SHOWING GOOD SIGNALS.

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.

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 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,

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SECOND TO LAST TRAJECTORY WHERE THEY NOTICED THE SCREW SKIVED MEDIALLY. THE SITE TRIED TO SEND TO RIGHT L5, BUT IT WAS NOT ON TRAJECTORY. THE SITE LOST SIGNAL IN THE RIGHT TIBIALIS ANTERIOR NERVE. THE PROCEDURE WAS DELAYED BY THREE TO FIVE MINUTES. THE LAST TWO SCREWS WERE COMPLETED FREEHAND. RIGHT L4 AND L5 WERE BOTH INACCURATE. THE SURGEON ESTIMATED THE DEVIATION TO BE BETWEEN 4-5MM. IT WAS THE LATERAL EDGE OF THE DRILL BIT THAT COMPLETELY BREACHED THE MEDIAL WALL.

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

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING THE PROCEDURE, ROSA ROBOT HAD THE MESSAGE "COLLISION DETECTED" WITHOUT SHOCK. ATTEMPTS WERE MADE BUT IMPOSSIBLE TO RECONNECT. THE INTERVENTION OF THE PATIENT WAS FINALLY CANCELLED FOR A REASON PARALLEL TO THE DYSFUNCTION OF ROSA AND THE REPRODUCTION OF THE PROBLEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

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.

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 MISPLACED SCREWS AFTER LOOKING AT THE X-RAYS. S1 WAS MISPLACED AND LEFT OUT. THE PATIENT WAS HAVING NUMBNESS AND SOME LOSS OF MOBILITY IN ONE LEG/FOOT. S1 LEFT WAS THE SCREW DEVIATED LATERALLY. THE DEVIATION WAS GREATER THAN 10MM. THE SURGEON WAS NOT USING BOTH HANDS WHEN PLACING THE SCREWS WITH THE DRILL. THE SUSPECTED CAUSE OF THE DEVIATION WAS EXCESSIVE FORCE FROM THE SOFT TISSUE. A REVISION SURGERY HAD TO BE PERFORMED. THE PROCEDURE WAS DELAYED BY LESS THAN ONE HOUR.

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