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 CYSTECTOMY WITH ILEAL DIVERSION SURGICAL PROCEDURE, DURING THE DISSECTION OF LYMPH NODES, THE MONOPOLAR CURVED SCISSORS (MCS) ACCESSORY CAME OFF FROM THE MCS INSTRUMENT, FALLING INTO THE PELVIC AREA. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITHOUT ISSUES. THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS INSPECTED, AND IT WAS NOTED TO BE VISUALLY ABNORMAL. IT WAS CLEANED WITH A WET CLOTH AND DRY SPONGE. A NEW TIP COVER WAS APPLIED, AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS IDENTIFIED. THE ASSISTANT RESIDENT USED A LAPAROSCOPIC FENESTRATED GRASPER TO RETRIEVE IT. THE MCS INSTRUMENT WAS IN USE FOR MORE THAN 1 HOUR. THE MCS INSTRUMENT WORKED FINE FOR THE MAIN DISSECTION OF URETERS PRIOR TO THE INCIDENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE USING THE INSTAL

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CAMERA IS BROKEN FULL DESCRIPTION ENTIRE SYSTEM NEEDS TO BE RUN FOR BUGS CAMERA IS BROKEN STORAGE IS LOW AND COMPUTER IS SLOW NEED TO BE DONE ASAP.

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 PHYSICIAN OBSERVED EXCESS AMOUNT OF BLOOD IN THE AIR WAY AFTER SUCCESSFULLY COMPLETING THE MONARCH BRONCHOSCOPY PROCEDURE. THE PHYSICIAN ELECTED TO USE THEIR MANUAL BRONCHOSCOPE AND COLD SALINE TO CLEAR THE AIRWAY; HOWEVER, COMPLICATIONS OCCURRED DURING THE POST-MONARCH BRONCHOSCOPY PROCEDURE. THE PATIENTS BLOOD HAD CLOTTED AND BLOCKED THE ENDOTRACHEAL TUBE (ET TUBE). THE PATIENT THEN FELL INTO CARDIAC ARREST DUE TO LACK OF VENTILATION FROM THE FROM THE BLOOD CLOT BEING PRESENT IN THE ENDOTRACHEAL TUBE (ET TUBE). THE PHYSICIAN FOLLOWED CARDIAC ARREST PROTOCOL AND WAS ABLE TO RECOVER THE PATIENT. THE PATIENT WAS ADMITTED INTO INTENSIVE CARE UNIT (ICU) ON THE SAME DAY. AFTER THE PATIENT WAS SENT TO RECOVERY IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT WAS GIVEN A CHEST X-RAY WHERE DOCTOR DISCOVERED THE PATIENT HAD EXPERIENCED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND REMOVED THE FOLLOWING DAY. THE PHYSICIAN STATED THE PNEUMOTHORAX WAS DUE TO LONG BAG VENTILATION TIME, EXCESS SUCTION, AND OVER ALL STRESS ON THE LUNG THAT OCCURRED DURING BLEEDING MANAGEMENT POST-MONARCH PROCEDURE. THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL.

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, THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE DUE TO NAVIGATIONAL DIFFICULTY AND POOR VISIBILITY. PATIENT MUCUS CONTRIBUTED SIGNIFICANTLY TO THE POOR VISIBILITY. THE PHYSICIAN DECIDED TO CONVERT THE DIAGNOSTIC PROCEDURE TO A MANUAL BRONCHOSCOPY PROCEDURE. IT WAS REPORTED THAT THE PATIENT DEVELOPED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF BLACK RUBBER BROKE OFF OF THE SEAL AND FELL INTO THE SURGICAL SITE. THE PROCEDURE AND THE PATIENT OUTCOMES ARE UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE PROCEDURE WAS ROBOTICALLY COMPLETED. PER THE SURGEON'S OPERATION NOTE AND DISCHARGE SUMMARY, THE FRAGMENT OF THE PORT WAS NOT EVEN MENTIONED. THE PATIENT WAS DISCHARGED ON TIME, AND IN STABLE CONDITION. NO PATIENT INJURY OR HARM WAS REPORTED. NO MEDIA IS AVAILABLE FOR REVIEW.

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 PULMONARY LOBECTOMY PROCEDURE, THE SYSTEM WAS LOCKED UP AND ARM 4 WAS VERY STIFF. THE CUSTOMER STATED THEY HAD TO PUSH THE EMERGENCY STOP BUTTON ON THE SYSTEM DUE TO CONVERTING TO PROCEDURE TO OPEN SURGERY. THE CUSTOMER EXPLAINED THE CASE WAS CONVERTED TO OPEN SURGERY DUE TO PATIENT ANATOMY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE EMERGENCY STOP FAULT WAS STILL ACTIVE ON THE SYSTEM. THE TSE HAD CALLER NAVIGATE TO THE SURGEON CONSOLE AND PUSH THE RESUME BUTTON TO RETURN THE SYSTEM BACK TO A NORMAL STATE. THE STAFF CONFIRMED THE SYSTEM FUNCTIONALITY RETURNED TO NORMAL AND ARM 4 WAS NOT STIFF ANYMORE. ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO ISSUE WITH THE ROBOT OTHER THAN STAFF NOT BEING AWARE OF THE EMERGENCY RESET BUTTON ON THE SURGEON CONSOLE. THE ROBOT WORKED AS EXPECTED DURING THE EMERGENCY WITH THE PATIENT. NO FURTHER DETAILS REGARDING THE CONVERSION WERE PROVIDED.

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 A PATIENT UNDERWENT A DA VINCI-ASSISTED SINGLE PORT (SP) BILATERAL NIPPLE SPARING MASTECTOMY AS PART OF A CLINICAL STUDY ON 31-OCT-2023. A BILATERAL NON-ROBOTIC RECONSTRUCTION PROCEDURE WAS PERFORMED IMMEDIATELY AFTER. AFTER THE PROCEDURE, WHILE THE PATIENT WAS STILL IN THE RECOVERY, AN INCREASE OF THE BLOOD FROM HER LEFT BREAST DRAIN AS WELL AS AN ENLARGED LEFT BREAST WERE IDENTIFIED. COMPRESSION WAS PERFORMED AT THE SITE AND INTRAVENOUS TRANEXAMIC ACID (TXA) WAS GIVEN TO HELP STOP THE BLEEDING. IN ADDITION, THE PATIENT WAS KEPT OVERNIGHT FOR MONITORING. NO SIGNS OF INFECTION WAS OBSERVED. THE HEMATOMA IMPROVED AND RESOLVED DURING HER HOSPITALIZATION. THE DRAINAGE VOLUME WAS STABILIZED WITH ONLY SEROSANGUINEOUS SEEN. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON 02-NOV-2023, AND THE ADVERSE EVENT WAS REPORTEDLY RESOLVED ON 02-NOV-2023. THE INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE PROCEDURE, BUT NOT RELATED TO DA VINCI DEVICES.

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 L2 LEFT WAS ACCURATE. THE SITE MOVED TO L3 LEFT AND UPON TAPPING THE ARM, THE SYSTEM STATED IT FELT A FORCE AND WAS NOT ON TRAJECTORY. THE ARM WAS MOVED AWAY AND THE ARM WAS RESENT TO L3 LEFT AND THE SCREW LOOKED ACCURATE, BUT IT WAS NOT ACCURATE. THE SCREW WAS REPOSITIONED MANUALLY, BUT IT APPEARED THAT THE NERVE ROOT WAS DAMAGED. ALL THE OTHER SCREWS WERE ACCURATE. THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TRYING TO START A CASE AND THE ROBOT WENT TO REBOOT AND SELECT PROPER BOOT DEVICE. NEED AN FSE FOR TOMORROW'S CASE WITH A NEW SURGEON.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING ROBOTIC REGISTRATION THE FLUORO SHOTS AND PRE-OP CT SCAN DID NOT ALIGN PROPERLY. WITH CLEAR FLUORO PHOTOS IT LOOKED AS IF THE ROBOT WAS PULLING AN OBLIQUE CT SLICE. WE HELD RESPIRATION, CENTERED EACH VERTEBRAE, SOFTWARE RESET, SWITCHED TO CRANIAL AND BACK WITH NO SUCCESS. I USED LIFE SAVER, BUT AT THAT POINT DR. (B)(6) CHOSE NOT TO CONTINUE WITH THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS THE INTRA-OP SPINE CASE. UNFORTUNATELY, THE TEAM COULDN'T GET THE AUTOMATIC REGISTRATION. IT HAD BEEN DONE ANOTHER SCAN WITH THE SAME RESULT. AFTER THE REGISTRATION WAS DONE MANUALLY, THE SURGEON NOTICED SOME NAVIGATION SHIFTS. THE ROBOTIC CASE WAS ABORTED AND DONE TRADITIONALLY. NO ADVERSE EFFECTS FOR THE PATIENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 AN OBSERVED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON INFORMED THE INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVES ABOUT RECURRENT INCIDENCES OF PATIENT INJURY INVOLVING THE 12MM CANNULA THAT IS PLACED LATERALLY IN THE 8TH INTERCOSTAL SPACE (ICS) DURING PULMONARY LOBECTOMY CASES. INJURIES INCLUDE PORT SITE BRUISING, ABRASIONS AND HAIRLINE FRACTURES IN 25% OF PATIENTS. PER THE SURGEON, THIS IS DUE TO THE CANNULA RUBBING AGAINST THE RIB (INTERNALLY) ABOVE THE ICS WHEN ANGLING UPWARDS. THIS RECURRENT ISSUE WAS THE FOCUS OF AN INTERNAL STUDY CONDUCTED BY SITE RADIOLOGISTS. ADDITIONALLY, PATIENTS EXPERIENCED POST-OPERATIVE PAIN. DURING FOLLOW UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR), IT WAS STATED THAT THE BRUISING AND HAIRLINE FRACTURE IS OCCURRING DESPITE CORRECT USE OF THE REMOTE CENTER CANNULA INDICATORS AND WAS SAID THAT IT WAS TYPICALLY CAUSED BY THE ANGLE NEEDED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) DURING STAPLING.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO HARDWARE ERROR. THIS EVENT OCCURRED IN THE UNITED KINGDOM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A LARGE BLEED.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ALL POWER LOST TO EGPS UNIT WHILE UNIT WAS PLUGGED INTO A VIABLE/TESTED POWER SOURCE. POWER SOURCE WAS USED IN TWO CASES DURING THE SAME DAY (B)(6) 2023. ALL FUNCTION AND AGENCY LOST TO THE EGPS UNIT DURING THIS TIME. BOTH THE BATTERY SYMBOL AND ON/OFF SYMBOL WERE NOT EMITTING ANY COLOR.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS EVENT OCCURRED IN AUSTRALIA.

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 - PARAOESOPHAGEAL SURGICAL PROCEDURE, THE JAW OF A HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SCREWS L2-S1, ALL LEFT SCREWS MEDIAL AND ALL RIGHT SCREWS LATERAL. WHEN REMOVING SCREWS, INITIALLY OUR SPIN WAS CORRECT AND NAVIGATION INTEGRITY WAS SOLID; HOWEVER, AFTER REMOVING ONE OR TWO MORE SCREWS, WHEN THE CHICKEN FOOT WAS AGAIN PLACED DOWN THE SCREW TRAJECTORY TO CONFIRM NAVIGATION ACCURACY, THE SCREW APPEARED TO BE MEDIAL TO WHERE THE TOOL WAS PLACED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE ENDOSCOPE WOULD NOT ROTATE. A BACKUP ENDOSCOPE WAS USED, AND THE PROCEDURE WAS CONVERTED TO OPEN. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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: IT WAS NOT POSSIBLE TO UPLOAD THE PLANNED CASE FROM LAPTOP TO THE ROBOT WITH USB STICK. WE GOT THE MESSAGE ''GPS CLIENT IS NOT RESPONDING''. SOFTWARE RESET, HARD SHUTDOWN DIDN'T HELP. THE SCREEN WAS FROZEN WITH THE MESSAGE ''IMPORTING CASE FROM USB''. THE CASE WAS DONE IN TRADITIONAL WAY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A SYSTEM FAULT OCCURRED DURING SETUP FOR A MONARCH BRONCHOSCOPY. THE PHYSICIAN ELECTED TO NOT START THE DIAGNOSTIC PROCEDURE. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT. (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, AURIS HEALTH, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

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 SITE REPORTED THAT HEAD SENSOR SOMETIMES NOT WORKING AND SYSTEM ASKS TO OPEN AND CLOSE GRIP MASTER TOOL MANIPULATOR (MTMS). INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS, THERE ARE ONLY THE COMMUNICATIONS ERRORS. SITE PERFORMED DIFFERENT ACTIONS TO TROUBLESHOOT THE ISSUE PER TSE RECOMMENDATION. BUT, PROBLEM DID NOT RESOLVE AND THE SURGEON CONVERTED THE SURGERY IN OPEN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROCEDURE WAS CONVERTED TO OPEN AS THE SURGEON COULD NOT MOVE THE MTMS ON THE CONSOLE FLUENTLY. EVEN IF HE WAS NOT MOVING HIS HEAD FROM THE 3D VIEWER, EVERY 2-3 MINUTES, THE SYSTEM RESPONDED AS IF THE DOCTOR JUST SAT AT THE CONSOLE, BLOCKING THE INSTRUMENTS AND THE MASTERS AND ASKING THE SURGEON TO MOVE THE GRIP. THE PROCEDURE WAS NOT CONVERTED FOR INTRA OPERATIVE COMPLICATIONS. THE PATIENT TOTALLY TOLERATED THE CHANGE. THERE WAS NO ANY INJURY TO THE PATIENT. SYSTEM MALFUNCTION OCCURRED PRIOR TO CONVERSION BUT, IT DID NOT LEAD TO ANY PATIENT HARM. ACCORDING TO THE SURGEON, THERE WAS A PR

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

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

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY.

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 PATIENT'S BLOOD PRESSURE AND HEART RATE BECAME ELEVATED AFTER BEING SEDATED. THE SURGEON CHOSE TO ABORT THE PROCEDURE, AS THEY DID NOT FEEL IT WAS CORRECT TO PROCEED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN INTRA-OP DBS CASE AT (B)(6) MEDICAL CENTER, A 2ND O-ARM EVALUATION SPIN SHOWED THAT THE LEAD WAS ~2 MM SUPERFICIAL TO THE PLANNED DEPTH. THE PLANNED DEPTH WAS 2 MM PAST THE TARGET BASED ON THE BURNED IN BRAINLAB LEFT VIM TRAJECTORY. FROM THE FIRST EVALUATION SPIN, THE LEAD WAS 6.5 MM ABOVE THE PLANNED DEPTH AND 4.5 MM ABOVE THE BURNED IN TARGET. AFTER OBSERVING THE RESULTS FROM THIS FIRST SPIN, DR. (B)(6) STATED THAT HE MAY HAVE PULLED BACK ON THE LEAD WHEN REMOVING THE CANNULA. HE WENT BACK IN AND MANUALLY ADVANCED THE LEAD 6.5 MM FURTHER TO ACCOUNT FOR THE DEPTH DISCREPANCY WHILE HAVING HIS PA PERFORM LFPS ON THE PATIENT. AFTER HE ADVANCED THE LEAD TO HIS DESIRED DEPTH, A 2ND EVALUATION SPIN WAS PERFORMED. THE RESULT OF THIS SPIN SHOWED THAT THE LEAD WAS EXACTLY TO TARGET DEPTH, WHICH IS 2 MM SUPERFICIAL FROM HIS PLANNED DEPTH.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOR A SINGLE POSITION LATERAL CASE AT L4-5 DURING CASE SET UP THE END EFFECTOR LATCH WAS VERY STICKY AND HARD TO CLOSE. AFTER THE FIRST MERGE WITH PREOP CT WORK FLOW WE RECEIVED A HIGH SURVEILLANCE MESSAGE, SO WE REMERGED AND RESETTLED SURVEILLANCE. AFTER DRILLING THE FIRST PEDICLE L4 LEFT IT DID NOT FEEL OR LOOK RIGHT SO WE BROUGHT IN FLUORO. THE LATERAL WAS TO PLAN BUT THE AP WAS VERY MEDIAL. WE AGAIN REMERGED AND RESETTLED SURVEILLANCE. WE SWITCHED OUT THE END EFFECTOR AND, ON THE 3RD, TRY WE WERE ABLE TO ACCURATELY PLACE BILATERAL PEDICLE SCREWS. WE NEED TO REPLACE THE END EFFECTOR. I WILL UPLOAD CASE LOGS FOR THIS CASE TO THE ECL MODULES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE PLACED QUATTRO SPIKE IN RIGHT PSIS AND SURVEILLANCE MARKER IS LEFT PSIS. WE TOOK X-RAYS FOR THE MERGE, AND ALL CONFIRMED L4 AND L5 VERTEBRAL BODIES. THE MERGE WAS SUCCESSFUL, AND X RAY CAME OUT. AT THIS POINT, THE REP HAD NOTICED THAT THE DRB ON THE LEFT WAS CLOSE TO PATIENT AND ASKED IF IT HAD BEEN LIKE THAT. I ASKED THE SURGEON IF THERE WAS A GAP, SURGEON CONFIRMED THAT THERE WAS. ROBOT WAS BROUGHT IN, AND STABILIZERS WERE PLACED. SURGEON MOVED FORWARD WITH PLACING LEFT L4, INSTRUMENTS DIDN'T LOOK RIGHT ON NAVIGATION, BUT SURGEON FELT FINE. WE DID L5 AND SAW SAME NAVIGATION ISSUE AFTER PLACING SCREW WE DECIDED TO TAKE A X RAY TO CONFIRM AND NOTICED WE WERE OFF. SURGEON THEN HAD ROBOT TAKEN OUT AND OPENED PATIENT UP. SCREWS REMOVED AND HE FINISHED THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT FRAGMENT WAS RETRIEVED BY THE ASSISTANT USING AN ENDOSCOPE. ALL FRAGMENTS WERE CONFIRMED TO HAVE BEEN RETRIEVED BY THE ASSISTANT AND NURSE. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED AND NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON BELIEVES THE CAUSE OF THE BREAK WAS AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE INSTRUMENT WAS USED FOR AN HOUR AND A HALF PRIOR TO THE BREAK. THE INSTRUMENT WAS BEING USED FOR GRASPING WHEN IT BROKE. THERE WAS NO FUNCTIONALITY ISSUE AND NO INSTRUMENT COLLISION PRIOR TO THE BREAKAGE. THE INSTRUMENT WAS ALSO NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS SOME RESISTANCE WHEN REMOVING THE INSTRUMENT THROUGH THE CANNULA, BUT NO DAMAGE TO THE CANNULA, AND NO FURTHER

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

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

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, A PNEUMOTHORAX WAS NOTED. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DAVINCI ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE END OF THE SYNCHRO SEAL CAME DETACHED. THE PIECE OF SHEATH WAS RETRIEVED, THEREFORE NO HARM TO THE PATIENTS. THE SURGEON FELT THIS OCCURRED DUE TO CLASHING OF INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO REPORTED DAMAGE. THE EVENT OCCURRED WHILE GRASPING AND CAUTERIZING WHEN THE ALLEGED INSTRUMENT WAS TOO CLOSE TO ANOTHER INSTRUMENT LEADING TO CLASHING. THE CLASH WAS DUE TO NARROW PELVIS. PER SURGEON, THE PORTS SHOULD HAVE BEEN PLACED HIGHER UP. THERE WAS NO ISSUE WITH INSTRUMENT FUNCTIONING BEFORE THE OCCURRENCE OF EVENT. THERE WAS NO RESISTANCE WHILE REMOVING THE INSTRUMENT FROM SURGICAL FIELD. THE FALLEN FRAGMENT WAS REMOVED THROUGH THE PORT WITH GRASPER. IT WAS SINGLE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH BACK-UP INSTRUMENT WITH NO PATIENT HARM. THERE IS NO REPORT OF POST SURGICAL COMPLICATIONS.

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

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

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

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

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED ON AN ONLINE NEWS ARTICLE THAT AFTER A PATIENT UNDERWENT A ROBOTIC ASSISTED OVARIAN CYSTECTOMY FOR HER OVARIAN TERATOMA, THE PATIENT EXPERIENCED HIGH FEVER AND ABDOMINAL PAIN. THE PATIENT WAS FOUND WITH SMALL INTESTINE PERFORATION. FOLLOW-UP HAS BEEN ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION, BUT THERE'S CURRENTLY NO INFORMATION ABOUT THE PROCEDURE DATE, NOR THE MEDICAL INTERVENTION THAT WAS PERFORMED TO ADDRESS THE COMPLICATION.

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

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