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 THE REVIEW OF A LITERATURE ARTICLE WHICH DESCRIBED A RETROSPECTIVE COHORT STUDY, A SINGLE-PORT TRANSVESICAL (TV) ROBOT-ASSISTED SIMPLE PROSTATECTOMY (RASP) WAS PERFORMED. THE ARTICLE NOTED THAT DURING THESE SURGERIES, THERE WERE TWO SUSPECTED VENOUS AIR EMBOLI IN THE COHORT. THE AUTHORS ATTRIBUTED THIS EFFECT TO PNEUMOVESICUM PRESSURES (>12 MMHG). ONE OF THE PATIENTS HAD A SPONTANEOUS RESOLUTION IN THE OPERATING ROOM WITH HIGH-FLOW OXYGEN AND REPOSITIONING TO LEFT LATERAL DECUBITUS. THE SECOND PATIENT REQUIRED MANAGEMENT IN THE INTENSIVE CARE UNIT FOR 3 DAYS; HE WAS ALSO THE ONLY PATIENT THAT REQUIRED CONTINUOUS BLADDER IRRIGATION (CBI) POST OPERATIVELY. THE AUTHORS ALSO NOTED THAT PNEUMOVESICUM PRESSURE WAS SET AT 10 MMHG USING AN AIRSEAL (CONMED, UTICA, NY, USA) SYSTEM. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT INTUITIVE PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. 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: THE SURGEONS COMPLAINT WAS THE FACT THAT WHILE ATTEMPTING TO MERGE THE L2 VERTEBRAL BODY, HE WAS UNABLE TO GET A BETTER MERGE BECAUSE OF THE LORDOTIC SHIFTING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE WERE INSTRUMENTING PEDICLE SCREWS AT T12 & L2 , SKIPPING THE FRACTURE LEVEL. THE E3D SPIN WENT FINE, AND INITIAL NAV INTEGRITY CHECKS SEEMED FINE AS WELL. WE PLACED ALL 4 SCREWS AT T12 / L2. WE BATTLED A LITTLE BIT OF SAVING BUT NOTHING SIGNIFICANT. WE TOOK AP SHOT AFTER SCREWS WERE PLACED, AND ALL FOUR SCREWS WERE COMPLETELY OUT OF THE PEDICLE. THE LEFT SIDE WAS LATERAL, AND RIGHT SIDE WAS 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE DISTAL SHAFT OFFSET ITSELF AND CAUSED PARTS OF AN INSTRUMENT TO FALL INTO THE PATIENT'S ABDOMEN. THE PARTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND NO FURTHER INFORMATION WAS AVAILABLE.

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: ALL OUR SCREWS WERE ON, WE USED PRE OP CT WORKFLOW WITH G-ARM. THEN WE TOOK AN X-RAY OF OUR LATERAL TRIAL, AND THE NAVIGATION WAS ON. WHEN PLACING THE IMPLANT, WE WERE 4/5MM OFF POSTERIOR. WE HAD TO GO BACK IN, OPEN THE PATIENT, RETRIEVE THE CAGE AND RE DO EVERYTHING, NAVIGATION APPEARED TO BE ON UP UNTIL THE CAGE.

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 A LITERATURE ARTICLE TRANSORAL ROBOTIC SURGERY IN OROPHARYNGEAL SQUAMOUS CELL CARCINOMA: A COMPARATIVE STUDY BETWEEN DA VINCI SINGLE-PORT AND DA VINCI XI SYSTEMS WAS PERFORMED. THE STUDY'S AIM WAS TO COMPARE THE INTRA- AND POST-OPERATIVE OUTCOMES, TECHNICAL ADVANTAGES, AND SHORTCOMINGS OF TRANSORAL RESECTIONS PERFORMED WITH THE DA VINCI SINGLE PORT (SP) AND THE DA VINCI XI SYSTEMS USING A LARGE-VOLUME ACADEMIC CENTER USING TRANSORAL ROBOTIC SURGERY (TORS) TO TREAT OROPHARYNGEAL SQUAMOUS CELL CARCINOMA (OPSCC). PATIENTS DIAGNOSED WITH AN OPSCC WHO UNDERWENT TORS BY THE SENIOR AUTHOR¿S (SHK) TEAM BETWEEN JANUARY 2015 AND JANUARY 2023 WERE INCLUDED. THE ARTICLE NOTED THAT THAT DURING THESE DV SURGERIES, A TOTAL OF 6 PATIENTS HAD MAJOR POST-OPERATIVE BLEEDING THAT REQUIRED HEMOSTASIS AND 4 PATIENTS WERE DEPENDENT ON TRACHEOTOMY AND FEEDING TUBE 6 MONTHS AFTER SURGERY IN THE SP GROUP. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGED THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: APOLOGIES, ORIGINAL REPORT DID NOT PROCESS. LOGS HAVE BEEN UPLOADED TO INR PORTAL. THERE WAS A SUSPECTED ISSUE WITH THE PREOP REGISTRATION/MERGE. T12 FRACTURE, SCREWS PLACED AT T10-11, L1-2. NAMELY, T11-L WAS PLACED LATERAL TO THE ORIGINAL PLACE. ADDITIONALLY, T10 SCREWS PLACED PROUD. AFTER DISCUSSION, SUSPECTED MISSTEP MAY HAVE BEEN PROPER PLACEMENT OF FLUORO FIXTURE BUT NO YET CAUSE DETERMINED. SCREWS WERE REPOSITIONED VIA TRADITIONAL MIS JAMSHID TECHNIQUE.

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 PHYSICIAN WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

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 PHYSICIAN WAS ADJUSTING THE SCOPE TOWARDS TARGET OF NODULE AND THE PATIENTS HEART RATE (HR) BEGAN TO DECLINE AND THE PHYSICIAN ABORTED THE CASE. THE PATIENT THEN WENT INTO ASYSTOLE AND REQUIRED EMERGENT CONVERSION AND CHEST COMPRESSIONS. ONCE THE PATIENT REGAINED A PULSE THE WERE TRANSPORTED THE INTENSIVE CARE UNIT (ICU) WHERE THE PATIENT CODED AGAIN AND WAS BEING SENT TO THE CARDIAC CATH LAB. THE PHYSICIAN STATED THAT THE ADVERSE EVENTS ARE NOT ATTRIBUTED TO THE MONARCH SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PLANNED SURGERY ON THE DORSAL CERVICAL SPINE INCLUDED A SCREW FIXATION C1/C3/C4. WHEN CHECKING THE SCREW POSITION IN THE 3D SCAN AFTER SCREW PLACEMENT, THE SURGEONS WERE NOT SATISFIED WITH THE SCREW POSITION OF A C1 SCREW. A NEW 3D SCAN WAS PERFORMED AND A NEW C1 SCREW WAS PLANNED INTRAOPERATIVELY. WHEN APPROACHING THE TRAJECTORY, THE ROBOTIC ARM STOPPED FAR AWAY FROM THE FINAL POSITION AND ONLY SHOWED A YELLOW FRAME. THE END EFFECTOR WAS SO FAR AWAY THAT THE INSTRUMENTS DID NOT REACH THE BONE. RESETTING THE SOFTWARE AND MOVING THE ROBOT ARM MANUALLY DID NOT CHANGE ANYTHING. BECAUSE THE ROBOT ARM WAS TOO FAR AWAY, THE C1 SCREW HAD TO BE INSERTED MANUALLY (WITH NAVIGATION OF THE ROBOT), BUT NOT BY THE END EFFECTOR.

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 REPEATED SYSTEM FAULTS OCCURRED DURING A MONARCH BRONCHOSCOPY. THE PHYSICIAN TRIED MULTIPLE BRONCHOSCOPES, BUT THE SYSTEM CONTINUED TO FAULT. THE PHYSICIAN ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE SUDDENLY BROKE. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO ISSUE OBSERVED AT THE TIME. THE REPORTED ISSUE OCCURRED WHILE PERFORMING A TISSUE-DISSOLVING PLANE. THE SURGEON BELIEVED WHAT CAUSED THE ISSUE WAS A QUALITY PROBLEM. THE HARMONIC ACE INSTRUMENT ISSUE OCCURRED AT THE START OF THE PROCEDURE. THE SURGEON NOTICED FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS REMOVED BEFORE THE BREAKAGE OCCURRED AND THE INSTRUMENT'S WRIST WAS EXTENDED OR STRAIGHTENED PRIOR TO REMOVAL. THE STAFF DID NOT FEEL RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A SPARE INSTRUMENT OF THE SAME KIND. NO ADDITIONAL MEDICAL PROCEDURES SUCH AS X-RAYS WERE PERFORMED POST-PROCEDURALLY. THERE WAS NO PA

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 SCREW TO BREACH THE PATIENT'S SPINAL CANAL.

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 — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING INVESTIGATION OF AN UNRELATED EVENT, A SURGEON NOTIFIED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE THAT THE COUNTY MEDICAL EXAMINER (ME), WHILE PROVIDING AUTOPSY RESULTS FOR THE UNRELATED EVENT, "RECALLED TWO PREVIOUS PATIENT DEATHS CAUSED BY ROBOTIC STAPLE LINES NOT HOLDING UP ON ARTERIES AND CAUSING BLEEDING." THE ME RECALLED THAT ONE PATIENT HAD RECEIVED A ROBOTIC-ASSISTED PROSTATECTOMY, AND THE OTHER PATIENT RECEIVED A ROBOTIC-ASSISTED SPLENECTOMY. THERE WAS NO ADDITIONAL INFORMATION EXCHANGED, OTHER THAN THE EVENTS OCCURRED AT DIFFERENT HOSPITALS. THE MEDICAL EXAMINERS OFFICE WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION. THE ME ASSISTANT STATED THEY WOULD REVIEW PREVIOUS CASES TO DETERMINE IF THERE WERE ANY SIMILAR CASES. UPON FOLLOW UP, THE ME ASSISTANT REPORTED FINDING A PROSTATECTOMY CASE FROM 2015, AND THE ONLY INFORMATION THEY COULD SHARE WAS THE DATE OF DEATH AND HOSPITAL WHERE THE PROCEDURE WAS PERFORMED. THERE WERE NO SIMILAR SPLENECTOMY CASES FOUND IN THE MEDICAL EXAMINERS RECORDS. THE MEDICAL EXAMINER DECLINED TO PROVIDE ANY FURTHER INFORMATION AND DESCRIBED THE CONVERSATION AS A BRIEF COLLEAGUE-TO-COLLEAGUE OBSERVATION. NO ADDITIONAL I

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED 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.

da Vinci Surgical System — Death 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, THE INFERIOR VENA CAVA (IVC) WAS INJURED. THE SURGEON REPORTED THAT THE INJURY OCCURRED DUE TO ATYPICAL ANATOMY. WHILE USING THE HARMONIC ACE SHEARS TO DIVIDE THE GASTROHEPATIC LIGAMENT, A MALPOSITION OF THE IVC RELATIVE TO ITS NORMAL POSITION WAS ENCOUNTERED. THE IVC WAS TENSELY PULLED ACROSS THE DIAPHRAGM AND UNRECOGNIZED AS IT WAS TUCKED RIGHT BEHIND THE GASTROHEPATIC LIGAMENT. THE SURGEON BELIEVES THE SIDEWALL OF THE IVC WAS UNKNOWINGLY GRASPED IN THE INSTRUMENT JAWS WHILE DIVIDING THE LIGAMENT. THE PROCEDURE WAS CONVERTED TO OPEN TO ADDRESS THE INJURY, BUT THE PATIENT EXPIRED. THERE WAS NO REPORTED INTUITIVE SURGICAL, INC. (ISI) PRODUCT MALFUNCTION.