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 AFTER A DA VINCI-ASSISTED RIGHT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT DEVELOPED A POSTOPERATIVE CHYLOTHORAX. THE SURGEON COMMENTED THAT THE SEALING OF THE SYNCHROSEAL MAY BE UNSATISFACTORY. THE PATIENT WAS HOSPITALIZED AND UNDER OBSERVATION. IT IS UNKNOWN IF ANY MEDICAL/SURGICAL INTERVENTION WAS TAKEN. THE PROCEDURE WAS COMPLETED AS PLANNED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR), WHO SPOKE TO THE CUSTOMER, AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM, INSTRUMENT AND ACCESSORY WERE INSPECTED BEFORE USE AND THERE WAS NOTHING OUT OF THE ORDINARY. THERE WAS NO MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT OR ACCESSORY THAT OCCURRED. THERE WAS NO EVIDENCE OF INSUFFICIENT SEALING/CAUTERY ISSUE/INTRA-OPERATIVE COMPLICATION OBSERVED DURING THE PROCEDURE AND THE SURGERY WAS COMPLETED AS PLANNED. THERE WAS NO UNEXPECTED BLEEDING OBSERVED DURING THE PROCEDURE. THE CUSTOMER CONFIRMED THAT THE TISSUE BUNDLE WAS LESS THAN 5 MM, THE TISSUE FIT IN THE JAWS OF THE INSTRUMENT, THERE WAS NO TISSUE TENSION, NO CONTACT WITH HARD MATERIAL, NO EVIDENCE OF VESSEL CALCIFICATION AND THE INSTRUMENT JAWS WERE NOT

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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS FOUND TO HAVE A MELTED TEFLON PAD. FRAGMENTS FROM THE INSTRUMENT REPORTEDLY FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION AND WERE "VERY HARD TO BE RETRIEVED." THE SURGEON RETRIEVED THE FRAGMENTS WITH A BACKUP INSTRUMENT AND NOTED CONCERN ABOUT THE QUALITY OF THE TEFLON PAD. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. THE FRAGMENTS ARE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. 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 DAMAGE IDENTIFIED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 10 TO 20 MINUTES BEFORE THE ISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. THE REPORTER NOTED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS AS WAS INITIALLY REPORTED. THERE WAS NO PATIENT INJURY

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM A HEMATOMA REQUIRING REOPERATION AND WASHOUT AFTER HIFU THERAPY. ON 15-JUN-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT THE DURING PORT INCISION, THERE WAS A VESSEL (VEIN) INJURY. AS A RESULT, THE PATIENT EXPERIENCED A HEMATOMA. THE ESTIMATED BLOOD LOSS INTRA-OPERATIVELY WAS 250-500MLS. THERE WAS PROCEDURE FOR A WASHOUT AND HEMOSTASIS. THERE WAS NO BLOOD TRANSFUSION ADMINISTERED TO THE PATIENT. THE SURGEON HAD CONFIRMED THERE WAS NO RELATION TO THE DA VINCI PRODUCT. HOWEVER, IT IS UNKNOWN IF THE TROCAR WAS AN ISI PRODUCT OR A THIRD-PARTY PRODUCT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT.

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 PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND REQUIRED HOSPITALIZATION IN THE ICU. THE SURGEON SAID HE NO LONGER WILL USE THE SYNCHROSEAL INSTRUMENT. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PROCEDURE OCCURRED IN JUNE BUT THE EXACT DATE WAS NOT PROVIDED. THE PROCEDURE WAS PERFORMED ON A DA VINCI SI SYSTEM WITH AN UNKNOWN SERIAL NUMBER. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL FOUND. THE SURGEON REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT. THE TARGET ISSUE WAS THE PROSTATE PEDICLE. THE TARGET TISSUE WAS REPORTEDLY UNDER TENSION DURING THE SEALING AND CUTTING PROCESS. THE TARGET TISSUE WAS NOT A VESSEL GREATER THAN 5MM, HAD NO CALCIFICATION, AND NO PREVIOUS RADIATION OR CHEMOTHERAPY. THE SURGEON REPORTED THAT THEY OBSERVED TISSUE EFFECT DURING THE SEALING/SYNCH CYCLE. THE SURGEON SAID THE SYNCHROSEAL INSTRUMENT NEVER CAME INTO CONTACT WITH METAL OBJECTS SUCH AS STAPLES, SUTURES, AND CLIPS DURING 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: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A EUROPEAN UROLOGY OPEN SCIENCE ARTICLE TITLED, ¿SALVAGE VERSUS PRIMARY ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY-MATCHED COMPARATIVE EFFECTIVENESS STUDY FROM A HIGH-VOLUME TERTIARY CENTRE¿ (NATHAN, A., FRICKER, M., ET AL., 2021). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS CITED -ONE PATIENT SUFFERED FROM RECTAL INJURY WITH INTRAOPERATIVE PRIMARY REPAIR FOLLOWING WHOLE GLAND RADIOTHERAPY. ISI HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO THE REACH OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE IS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT. MOREOVER, THERE IS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THAT AN INTUITIVE PRODUCT CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION REFERENCED IN THE ARTICLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 22-NOV-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A INTERNATIONAL JOURNAL OF UROLOGY CASE REPORTS ARTICLE TITLED, ¿ENDOSCOPIC LASER TREATMENT FOR URINE LEAKAGE CAUSED BY AN ISOLATED CALYX AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY¿ (INOUE, R., ISOYAMA, N., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, A POST-OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: "AN (B)(6) MAN UNDERWENT ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR THE TREATMENT OF RENAL CELL CARCINOMA (CT1BN0M0). POSTOPERATIVELY, URINE LEAKAGE WAS OBSERVED AND DID NOT IMPROVE WITH CONSERVATIVE MEASURES. RETROGRADE PYELOGRAPHY AND COMPUTED TOMOGRAPHY REVEALED THAT URINE LEAKAGE ORIGINATED FROM THE ISOLATED CALYX CAUSED BY INFUNDIBULAR STENOSIS. ENDOSCOPIC TREATMENT VIA THE TRANSURETHRAL APPROACH WAS SELECTED TO PRESERVE RENAL FUNCTION. URETEROSCOPY SHOWED THAT THE UPPER CALYX WAS COMPLETELY OBSTRUCTED BY THE SUTURES. THEREFORE, WE CUT THE SUTURE THREAD USING LASER, AND A URETERAL STENT WAS PLACED IN THE UPPER RENAL CALYX. FLUID DRAINAGE IMMEDIATELY DISAPPEARED AFTER THE PROCEDURE, AND THE PATIENT DID NOT LOSE RENAL FUNCTION." ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT

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, PIECES FROM THE CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE ALL FRAGMENTS DURING THE SAME PROCEDURE. THE CANNULA SEAL IS AVAILABLE FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION; HOWEVER, THE FRAGMENTS ARE NOT ABLE TO BE RETURNED. THE CUSTOMER REPLACED THE CANNULA SEAL WITH A BACK-UP ACCESSORY OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT LOWER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED.

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 PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND REQUIRED HOSPITALIZATION IN THE ICU. THE SURGEON SAID HE NO LONGER WILL USE THE SYNCHROSEAL INSTRUMENT. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PROCEDURE OCCURRED IN JUNE BUT THE EXACT DATE WAS NOT PROVIDED. THE PROCEDURE WAS PERFORMED ON A DA VINCI SI SYSTEM WITH AN UNKNOWN SERIAL NUMBER. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL FOUND. THE SURGEON REPORTED THAT THE SYNCHROSEAL INSTRUMENT WORKED FINE AND NO ERRORS WERE GENERATED FOR THE INSTRUMENT. THE TARGET ISSUE WAS THE PROSTATE PEDICLE. THE TARGET TISSUE WAS REPORTEDLY UNDER TENSION DURING THE SEALING AND CUTTING PROCESS. THE TARGET TISSUE WAS NOT A VESSEL GREATER THAN 5MM, HAD NO CALCIFICATION, AND NO PREVIOUS RADIATION OR CHEMOTHERAPY. THE SURGEON REPORTED THAT THEY OBSERVED TISSUE EFFECT DURING THE SEALING/SYNCH CYCLE. THE SURGEON SAID THE SYNCHROSEAL INSTRUMENT NEVER CAME INTO CONTACT WITH METAL OBJECTS SUCH AS STAPLES, SUTURES, AND CLIPS DURING THE PROCEDURE

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MAKO HIP CASE, MANUAL REAMING WAS ENABLED. THE MEDIAL DISTANCE REMAINING NUMBER SHOWED WE STILL HAD OVER 3MM TO GO, HOWEVER THE SURGEON WENT THROUGH THE MEDIAL WALL. ADDITIONALLY, THE 3D BONE MODEL SHOWED THAT WE WENT THROUGH THE MEDIAL WALL, WHILE THE MEDIAL DISTANCE TO REAM NUMBER WAS STILL OVER 3MM. NO SURGICAL DELAY. CASE TYPE / APPLICATION: LTHA UPDATE 03/JUNE/2021 WG: AS PER MPS RESPONSE, SURGEON ADDRESSED THE ISSUE BY MANUALLY INFERIORIZING THE CUP. SURGICAL DELAY 10 MINUTES.

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 PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OF THE MCS INSTRUMENT AND FELL INTO THE PATIENT. THE MCS TIP COVER ACCESSORY WAS REMOVED FROM THE PATIENT AND WAS REPORTEDLY DISCARDED. THE PROCEDURE WAS COMPLETED USING A BACKUP MCS TIP COVER ACCESSORY WITH NO REPORTED INJURY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) PROVIDED THE FOLLOWING INFORMATION: THE OPERATING ROOM NURSE WHO REPORTED THIS ISSUE TO THE CTA STATED SHE DOES NOT HAVE THE EVENT DATE INFORMATION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. INSTALLATION OF TIP COVER ACCESSORY ON THE MCS INSTRUMENT WAS "EASIER THAN NORMAL." THE MCS TIP COVER ACCESSORY FELL INTO THE ABDOMEN AND THEY RETRIEVED IT WITH THE REMAINING INSTRUMENTS. INSTRUMENT REMOVAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE NURSE TOLD THE CTA THAT THE MCS TIP COVER ACCESSORY AND THE MCS WERE NOT BEEN DAMAGED. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. NO ELECTROLUBE OR OTHER LUBRICANT APPLIED TO THE MCS INSTRUMENT 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE WAS SUDDENLY BROKEN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS USED FOR ABOUT ONE HOUR AND THE INSTRUMENT BLADE WAS BROKEN INSIDE THE PATIENT. THE SURGEON REMOVED THE FRAGMENT BY USING A GRASPER, DURING THE SAME PROCEDURE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE FOUND. DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE INSTRUMENT BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED UPON VISUAL INSPECTION. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THERE WAS NO PATIENT INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NO

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 GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL DISC FELL OFF OF THE SYNCHROSEAL INSTRUMENT AND INTO THE ABDOMEN OF THE PATIENT. THE SMALL DISC WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON (B)(6) 2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED VIA ROBOTIC INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND WAS UNSURE OF THE CAUSE OF THE ISSUE. THE FOLLOWING WAS INFORMATION WAS REQUESTED, BUT WAS UNKNOWN: WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE ISSUE, HOW LONG THE INSTRUMENT HAD BEEN IN USE AT THE TIME OF THE ISSUE, IF THERE WERE ANY COLLISIONS, IF THE INSTRUMENT WAS REMOVED THROUGH THE CANNULA PRIOR TO THE ISSUE, AND IF THERE WAS ANY OTHER DAMAGE TO THE INSTRUMENT OR THE CANNULA ONCE THE INSTRUMENT HAD BEEN REMOVED. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI. THERE ARE PHOTOGRAPHIC IMAGES AVAILABLE OF THE INSTRUMENT AND THE FRAGMENT. PATIENT-RE

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 THAT STARTING UP THE ROSA ONE SYSTEM BEFORE THE SURGERY AND FIND THAT ROSA CANNOT ACCESS THE ROSA SPINE INTERFACE, TO START BUILDING THE PATIENT FOLDER. THE SURGERY WAS CONVERTER TO A TRADITIONAL SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE ARE HAVING A PATTERN OF DIFFICULTIES WITH OUR ROSA MACHINE. THESE DIFFICULTIES ROUTINELY FOLLOW ANY SORT OF 'MAINTENANCE' PERFORMED BY THE REGIONAL TECHNICIANS. TODAY WE HAD TO CANCEL A SURGERY WITH THE PATIENT IN THE PRE-OPERATIVE AREA BECAUSE AFTER AN HOUR OF TROUBLESHOOTING, THE ROSA MACHINE STILL WOULD NOT CONNECT ITSELF TO THE MONITOR TO BE FUNCTIONAL. THE ROSA MACHINE WAS WORKING FINE PRIOR TO ITS LAST 'MAINTENANCE' BY THE REGIONAL TECHNICIAN. WE ARE NOW BEING TOLD THAT THE TECHNICIAN WILL NOT BE ABLE TO ATTEND TO THE REPAIR UNTIL NEXT WEEK CAUSING US TO POST-PONE THIS NEEDED SURGERY EVEN FURTHER.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE NUMBER: (B)(4): (B)(6) - MPS REPORTED SURGEON REQUEST FOR SERVICE VISIT DUE TO INACCURATE CUTS DURING TKA CASE. MPS REPORTED THAT DOCTOR SAID THE CUTS FELT OFF IN TKA CASE AND THAT ANTERIOR CUT NOTCHED EVEN THOUGH IT SHOULD HAVE HAD ENOUGH FLEXION NOT TO. A COUPLE MONTHS AGO THIS SAME KIND OF ISSUE HAPPENED SO THE DOCTOR IS INSISTING FSE MAKE A VISIT.

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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT DEVELOPED AN IATROGENIC PNEUMOTHORAX IN THE LEFT UPPER LOBE (LUL). THE PATIENT HAD POSTPROCEDURAL CHEST X-RAYS AT 3:30 P.M. THAT DEMONSTRATED A SMALL APICAL 3-4 MM PNEUMOTHORAX. REPEAT CHEST X-RAY AT 6:30 P.M. SHOWED INCREASED PNEUMOTHORAX TO 1 CM DESPITE BEING ON A FULL-FACE MASK. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND PLACED ON 15 L SALTER CANNULA FOR SUPPORTIVE TREATMENT OF THE PNEUMOTHORAX. OVERNIGHT, THE PATIENT HAD REPEATED X-RAYS WHICH WAS FOUND TO BE STABLE AND THERE WAS NO EVIDENCE OF DESATURATION WITHOUT SUPPLEMENTAL O2. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PRIOR TO THE START OF SURGERY, UPON ATTEMPT TO MERGE AUTOMATICALLY MP2RAGE IMAGE TO T1 IMAGE, ERROR EXPERIENCED WHERE MANUAL ADJUSTMENTS WERE NECESSARY. ADDITIONALLY, AUTOMATICALLY MERGING CT IMAGE HAD SIGNIFICANT ERROR WHEN MERGED TO T1 MRI AND LESS, BUT STILL SIGNIFICANT ERROR WHEN MERGED TO MP2RAGE MRI IMAGE. THIS ISSUE CAUSED A 45 MINUTE DELAY WHILE PATIENT WAS UNDER ANESTHESIA.

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 THAT THE FOLLOWING OCCURRED AT AN INDEPENDENT SITE DURING AN ABLATION PROCEDURE WHERE NO CLINICAL REPRESENTATIVE WAS PRESENT. THE MERGE BETWEEN THE O-ARM SPIN AND THE T1 MRI WAS UNSUCCESSFUL (AND NECESSARY FOR MARKER REGISTRATION). THE SURGEON WAS NOT ABLE TO MANUALLY ADJUST THE MERGE IN A SATISFACTORY MANNER AND ABANDONED THE USE OF ROSA FOR THIS PROCEDURE, CHOOSING INSTEAD TO USE A CRW FRAME. THE IMPACT TO THE SURGERY WAS A DELAY OF ABOUT 25 MINUTES DUE TO THE TIME WASTED TO SET UP THE ROSA AND RETRIEVE THE CRW.

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 MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON FURTHER REVIEW, IT IS NOTED THE PATIENT EXPERIENCED A BLISTER. BLISTERS ARE A FLUID FILLED SAC LOCATED UNDER THE TOP LAYER OF THE SKIN. THESE RESULT DUE TO HEAT OR FRICTION AT THE SITE AND MOST OFTEN RESOLVE ON THEIR OWN. REVIEWING THE OFFICE NOTE PROVIDED, THE DOCTOR DOES NOT MENTION AN INTERVENTION AND STATES HE EXPECTS THE BLISTER TO RESOLVE ON ITS OWN. AS A BLISTER IS A MILD INJURY AND NO INTERVENTION IS NOTED, THIS WOULD NOT BE CONSIDERED A SERIOUS INJURY OR REPORTABLE.

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-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED BLEEDING. NO BLOOD TRANSFUSION AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PNEUMOTHORAX WAS DISCOVERED DURING ENDOBRONCHIAL ULTRASOUND. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

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

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LASER ABLATION CASE WAS PERFORMED. REGISTRATION WAS DONE VIA CONTACTLESS METHOD ON ROSA AND WAS ACCEPTED BY SOFTWARE BUT VERIFICATION SHOWED LESS THAN OPTIMAL RESULTS. SURGEON STATED THAT HE WAS SATISFIED WITH THE REGISTRATION REGARDLESS OF VERIFICATION AND CASE PROCEEDED. AFTER BOLTS WERE PLACED AND MRI DONE, BOTH TRAJECTORIES WERE FOUND TO BE INACCURATE WHEN COMPARED TO PLANNING. BOTH TRAJECTORIES WERE REDONE USING LEKSELL FRAME AND BOX WITHOUT ROSA ON SECOND ATTEMPT. THERE WAS PATIENT IMPACT, AS BOLTS WERE REMOVED AND TWO ADDITIONAL BOLTS 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 PROSTATECTOMY PROCEDURE, THE USER OBSERVED THAT "THE PART THAT HOLDS THE SYNCHROSEAL INSTRUMENT JAW COVER WAS DAMAGED" AND A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER NOTED THAT THE INSTRUMENT WAS NOT INVOLVED IN ANY KNOWN INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED AND REPLACED TO THE BACKUP. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND FOUND NO ISSUE. INSTRUMENT OPERATED WITH NO FUNCTIONAL ISSUE. SURGEON ALLEGES NO INCIDENT OF INSTRUMENT COLLISION. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY AN HOUR. THE FALLEN FRAGMENT WAS REMOVED THROUGH THE ASSIST PORT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. STANDARD POST-OPERATIVE TESTS WERE PERFORMED AND CONFIRMED NO RETAINED FRAGMENT.

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: DA VINCI XI ROBOT EXPERIENCED NONRECOVERABLE FAULT ERROR CODE 307 DURING MID PROCEDURE. INSTRUMENT ARMS WERE LEFT IN PATIENT. REP ADVISED TOTAL SYSTEM SHUTDOWN AND RESTART. SYSTEM SHUT DOWN AND RESTARTED 3 TIMES, NONRECOVERABLE FAULT RESULTED EACH TIME. INSTRUMENTS AND DA VINCI REMOVED MANUALLY AS RESULT OF FAILURE. PROCEDURE CONTINUED THORACOSCOPICALLY. AFTER TROUBLESHOOTING THIS ISSUE, DA VINCI REP DETERMINED THE TITLE PRO CABLE CONNECTED TO THE STORZ CAMERA SYSTEM FRIED THE TITLE PRO INPUT BOX IN THE DA VINCI ROBOT, RESULTING IN NONRECOVERABLE FAULT ERROR CODE 307. VENDOR CAME ONSITE 5/16 AND REPAIRED UNIT. UNIT RETURNED TO SERVICE. VIDEO OUTPUT ON VISION TOWER WAS REPLACED. COMPOSITE VIDEO COMPONENT PROTRUDES FROM EQUIPMENT LEADING TO HIGHER LIKELIHOOD OF DAMAGE. FDA SAFETY REPORT ID # (B)(4).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOT-ASSISTED SPINE SURGERY CONTINUES TO RAPIDLY DEVELOP AS EVIDENCED BY THE GROWING LITERATURE IN RECENT YEARS. IN ADDITION TO DEMONSTRATING EXCELLENT PEDICLE SCREW ACCURACY, EARLY STUDIES HAVE EXPLORED THE IMPACT OF ROBOT-ASSISTED SPINE SURGERY ON REDUCING RADIATION TIME, LENGTH OF HOSPITAL STAY, OPERATIVE TIME, AND PERIOPERATIVE COMPLICATIONS IN COMPARISON TO CONVENTIONAL FREEHAND TECHNIQUE. RECENTLY, THE MAZOR X STEALTH EDITION WAS INTRODUCED IN 2018. THIS ROBOTIC SYSTEM INTEGRATES MEDTRONIC¿S STEALTH NAVIGATION TECHNOLOGY INTO THE MAZOR X PLATFORM, WHICH WAS INTRODUCED IN 2016. IT IS UNCLEAR WHAT THE IMPACT OF THESE ADVANCEMENTS HAVE MADE ON CLINICAL OUTCOMES. TO COMPARE THE OUTCOMES AND COMPLICATIONS BETWEEN THE MOST RECENT ITERATIONS OF THE MAZOR ROBOT SYSTEMS: MAZOR X AND MAZOR X STEALTH EDITION. AMONG FOUR DIFFERENT INSTITUTIONS, WE INCLUDED ADULT (=18 YEARS OLD) PATIENTS WHO UNDERWENT ROBOT-ASSISTED SPINE SURGERY WITH EITHER THE MAZOR X (NON-NAVIGATED ROBOT) OR STEALTH (NAVIGATED ROBOT) PLATFORMS. PRIMARY OUTCOMES INCLUDED ROBOT TIME PER SCREW, FLUOROSCOPIC RADIATION TIME, SCREW ACCURACY, ROBOT ABANDONMENT, AND CLINICAL OUTCOMES WITH A MINIMUM 90 DAY FOLLOW UP.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOT-ASSISTED SPINE SURGERY CONTINUES TO RAPIDLY DEVELOP AS EVIDENCED BY THE GROWING LITERATURE IN RECENT YEARS. IN ADDITION TO DEMONSTRATING EXCELLENT PEDICLE SCREW ACCURACY, EARLY STUDIES HAVE EXPLORED THE IMPACT OF ROBOT-ASSISTED SPINE SURGERY ON REDUCING RADIATION TIME, LENGTH OF HOSPITAL STAY, OPERATIVE TIME, AND PERIOPERATIVE COMPLICATIONS IN COMPARISON TO CONVENTIONAL FREEHAND TECHNIQUE. RECENTLY, THE MAZOR X STEALTH EDITION WAS INTRODUCED IN 2018. THIS ROBOTIC SYSTEM INTEGRATES MEDTRONIC¿S STEALTH NAVIGATION TECHNOLOGY INTO THE MAZOR X PLATFORM, WHICH WAS INTRODUCED IN 2016. IT IS UNCLEAR WHAT THE IMPACT OF THESE ADVANCEMENTS HAVE MADE ON CLINICAL OUTCOMES. TO COMPARE THE OUTCOMES AND COMPLICATIONS BETWEEN THE MOST RECENT ITERATIONS OF THE MAZOR ROBOT SYSTEMS: MAZOR X AND MAZOR X STEALTH EDITION. AMONG FOUR DIFFERENT INSTITUTIONS, WE INCLUDED ADULT (=18 YEARS OLD) PATIENTS WHO UNDERWENT ROBOT-ASSISTED SPINE SURGERY WITH EITHER THE MAZOR X (NON-NAVIGATED ROBOT) OR STEALTH (NAVIGATED ROBOT) PLATFORMS. PRIMARY OUTCOMES INCLUDED ROBOT TIME PER SCREW, FLUOROSCOPIC RADIATION TIME, SCREW ACCURACY, ROBOT ABANDONMENT, AND CLINICAL OUTCOMES WITH A MINIMUM 90 DAY FOLLOW UP.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOT-ASSISTED PLATFORMS IN SPINE SURGERY HAVE RAPIDLY DEVELOPED INTO AN ATTRACTIVE TECHNOLOGY FOR BOTH THE SURGEON AND PATIENT. ALTHOUGH CURRENT LITERATURE IS PROMISING, MORE CLINICAL DATA IS NEEDED. THE PURPOSE OF THIS PAPER IS TO DETERMINE THE EFFECT OF ROBOT-RELATED COMPLICATIONS ON CLINICAL OUTCOMES THIS MULTICENTER STUDY INCLUDED ADULT (=18 YEARS OLD) PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR FUSION SURGERY FROM 2012-2019. THE MINIMUM FOLLOW-UP WAS 1 YEAR AFTER SURGERY. BOTH BIVARIATE AND MULTIVARIATE ANALYSES WERE PERFORMED TO DETERMINE IF ROBOT-RELATED FACTORS WERE ASSOCIATED WITH REOPERATION WITHIN 1 YEAR AFTER PRIMARY SURGERY. A TOTAL OF 320 PATIENTS WERE INCLUDED IN THIS STUDY. THE MEAN (STANDARD DEVIATION) CHARLSON COMORBIDITY INDEX WAS 1.2 (1.2) AND 52.5% OF PATIENTS WERE FEMALE. INTRAOPERATIVE ROBOT COMPLICATIONS OCCURRED IN 3.4% OF PATIENTS AND INCLUDED INTRAOPERATIVE EXCHANGE OF SCREW (0.9%), ROBOT ABANDONMENT (2.5%), AND RETURN TO THE OPERATING ROOM FOR SCREW EXCHANGE (1.3%). THE 1-YEAR REOPERATION RATE WAS 4.4%. ROBOT FACTORS, INCLUDING ROBOT TIME PER SCREW, OPEN VS. PERCUTANEOUS, AND ROBOT SYSTEM, WERE NOT STATISTICALLY DIFFERENT BETWEEN THOSE WHO RE

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET AND PNEUMOTHORAX WERE LOCATED RIGHT UPPER LOBE. AN ENDOBRONCHIAL ULTRASOUND WAS PERFORMED. A CHEST TUBE WAS PLACED IN THE PATIENT AND PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021.

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 DONE TO REMOVE MISPLACED SCREWS AT L4 CAUSING ADVERSE EFFECTS TO THE PATIENT.

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-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT INTO A COMPLETE HEART BLOCK AND BECAME HYPOTENSIVE. EPINEPHRINE WAS PUSHED INTO THE PATIENT¿S INTRAVENOUS TO TACKLE HYPOTENSION AND THE SCOPE WAS REMOVED IMMEDIATELY. THE CUSTOMER TOOK THE SCOPE OFF THE ROBOTIC ARMS AT THIS TIME AND WENT ON TO REMOVE THE SCOPE OUT OF PATIENT MANUALLY. THE PATIENT SUBSEQUENTLY BECAME STABLE, E.G., SHOWED INFERIOR WALL ACUTE MYOCARDIAL INFARCTION (AMI). THE PATIENT WENT TO THE CARDIAC CATHETERIZATION LAB IMMEDIATELY AND HAD AN EMERGENT ANGIOGRAM. THE PATIENT HAS RECOVERED AND HAS BEEN DISCHARGED.

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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED VIA A CHEST X-RAY AFTER THE PROCEDURE WHEN THE PATIENT WAS AWAKE AND COMPLAINED ABOUT CHEST PAIN. THE TARGET AND PNEUMOTHORAX LOCATION WERE IN THE LEFT LOWER LOBE (LLL). A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED THE NEXT DAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL REPRESENTATIVE (CR) ASSISTED THE SURGEON FOR AN ABLATION/BIOPSY CASE. CONTACTLESS REGISTRATION WAS PERFORMED, AND ACCURACY APPEARED TO BE GOOD. VERIFICATION LOOKED GREAT, SO SURGERY WAS STARTED. AFTER VERIFICATION, THE SURGEON MARKED THE ENTRY POINTS USING A MARKER AND THE LASER. AFTER DRAPING THE PATIENT AND GOING TO THE FIRST TRAJECTORY WITH THE DRILL ADAPTOR, THE SURGEON NOTICED THAT THE POINT OF THE DRILL ADAPTOR APPEARED TO BE MISSING THE MARK MADE ON THE PATIENT SKIN BY ABOUT 4-5MM. THE SURGEON WASN'T SURE IF THE LOCAL ANESTHESIA THAT WAS APPLIED TO THE AREA WAS CAUSING THE SKIN TO DEFORM, OR IF MAYBE THE DRAPING ON THE PATIENTS HEAD WAS PULLING THE SKIN SLIGHTLY TO SHOW THIS ISSUE. THE SURGEON AND CR DID NOT NOTICE ANY HEAD-SHIFT. THE SURGEON DECIDED TO PROCEED AND PLACE THE BOLTS FOR THE LEADS (TRAJECTORY 1 AND 2). AFTER PLACING THE BOLTS, THE SURGEON DIDN'T FEEL CONFIDENT THEY WERE PLACED CORRECTLY, SO THE SURGEON PLACED THE LEADS INTO THE BOLT, BUT JUST A CENTIMETER OR SO INTO THE BRAIN TO GET AN IDEA IF THE BOLTS WERE PLACED CORRECTLY. AROUND 9:57AM EASTERN TIME, THE POST-OP SCAN WAS MERGED, AND IT WAS CONFIRMED THAT THE BOLTS FOR EACH TRAJECTORY WERE AROUND

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-PARAESOPHAGEAL SURGICAL PROCEDURE, PART OF THE SHEAR OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED FROM THE ABDOMEN. THE CUSTOMER OPENED ANOTHER HARMONIC ACE INSTRUMENT TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 PANCREATECTOMY SURGICAL PROCEDURE, A PLASTIC PART FROM THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT WAS USED TO CONTINUE. 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 CUSTOMER RETRIEVED FRAGMENTS AND CONFIRMED BY VISUAL INSPECTION THAT ALL BROKEN PIECES WERE RETRIEVED. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENTS. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR LESS THAN 1 HOUR PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE SURGEON WAS REMOVING THE INSTRUMENT WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE EVENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE FINAL REMOVA

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 A SCAN & PLAN CASE FOR L3-L4 OLIF WITH PERC SCREWS WAS COMPLETED. THE PROCEDURE STARTED BY TAKING A SPIN WITH THE O-ARM AND SENDING THE IMAGES TO THE GUIDANCE SYSTEM FOR PLANNING. WHILE PLANNING FOR THE SCREWS WAS DONE, THE SURGEON DID THE EXPOSURE FOR THE OLIF. THE SURGEON THEN EXECUTED THE SCREWS, PERFORMED THE OLIF, AND THEN WENT BACK TO PLACE RODS. SCOUT SHOTS TAKEN DURING THE PROCEDURE SHOWED THE SCREWS LOOKED OK IN THE LATERAL VIEW. ANOTHER LATERAL IMAGE WAS DONE AND THE SCREWS LOOKED TO BE IN A DIFFERENT POSITION. AN AP IMAGE WAS TAKEN AND THE SCREWS ON THE LEFT SIDE WERE FOUND TO BE LATERAL BY 3.5-10 MM. THE LEFT L3 AND L4 SCREWS WERE REMOVED DURING THE PROCEDURE. A POST OPERATIVE CT SCAN WAS DONE OF THE RIGHT SIDE AND THE SCREWS WERE MEDIAL IN THE CANAL. A REVISION WAS DONE TO REMOVE THE RIGHT SIDE SCREWS. NO TROUBLESHOOTING WAS DONE DURING THE PROCEDURE SINCE THE SURGEON THOUGHT THE DEVIATION MAY HAVE BEEN CAUSED WHEN TRYING TO TIGHTEN THE RODS. IMAGING WAS NOT DONE PRIOR TO THAT. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

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 BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED AND NO PARTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT REGARDING 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 CUSTOMER CALLED IN TO REPORT THAT THEY COULD NOT REMOVE AN INSTRUMENT FROM ARM 1. THE TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED TO PRESS THE INSTRUMENT DRIVE RELEASE BUTTON, AND THE CUSTOMER STATED THAT SHE HAD ALREADY TRIED THAT. THE TSE ADVISED TO PRESS THE EMERGENCY-STOP BUTTON ON THE PATIENT SIDE CART (PSC), AND THE CUSTOMER STATED THAT THEY HAD ALREADY MOVED THE PSC AWAY FROM THE PATIENT. THE TSE INSTRUCTED THE CUSTOMER TO PRESS THE RELEASE TABS AND WIGGLE THE PATIENT SIDE MANIPULATOR (PSM), AND THE CUSTOMER STATED THAT IT WAS NOT MOVING. THE CUSTOMER REPORTED THAT THEY FINALLY WERE ABLE TO REMOVE THE INSTRUMENT. THE TSE INSTRUCTED THE CUSTOMER TO RESEAT THE STERILE ADAPTER AND TRY A TRAINING INSTRUMENT. THE CUSTOMER RESEATED THE INSTRUMENT ARM DRAPES, CONFIRMED THE DISCS WERE SPINNING, AND INSTALLED THE TRAINING INSTRUMENT. IT WAS NOTED THAT PSM 1 STILL HAD A YELLOW LIGHT EMITTING DIODE (LED), AND THE TRAINING INSTRUMENT WAS NOT RECOGNIZED. THE TSE HAD THE CUSTOMER REMOVE THE TRAINING INSTRUMENT AND STERILE ADAPTER, AND THE CUSTOMER REPORTED THAT ONE OF THE INSTRUMENT PRESENCE PINS ON PSM 1 WAS BROKEN/

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 HARMONIC ACE INSTRUMENT SHEARS BROKE. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT IN CARDIAC ARREST FROM A TENSION PNEUMOTHORAX. A NEEDLE DECOMPRESSION WAS USED, AND PATIENT REGAINED THEIR PULSE. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IMMEDIATELY AFTER COMPLETING BONE PREPARATION, AND POSTERIOR BONE FRAGMENTS WERE REMOVED IT WAS OBSERVED THAT THE POPLITEAL TENDON WAS NICKED AND BLEEDING. BLEEDING WAS ABLE TO BE ISOLATED AND SUTURED WITH MINIMAL DELAY IN THE CASE. SURGEON WAS REQUESTING FURTHER INFORMATION ABOUT IF THERE HAVE BEEN OTHER REPORTED INCIDENTS OF SIMILAR OCCURRENCES TO HELP ESTABLISH WHICH CUT HE MAY HAVE CAUSED THE NICK ON.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPANY REPRESENTATIVE (CR) WAS IN HOSPITAL TO SUPPORT A BILATERAL SEEG. SURGEON PLANED ALL 16 TRAJECTORIES FROM BRAINLAB BURNED IN ON ROSA. WHEN WE TRIED TO LOAD THE LATEST CT WITH FIDUCIALS ROSANNA CRASHED. AFTER LOADING PATIENT FOLDER 4 TRAJECTORIES WERE MISSING COMPLETELY. 1 WAS CHANGED. SURGEON REPLANNED THE 5 TRAJECTORIES AND CHECKED ALL OTHERS AS WELL. (65 MINUTES DELAY). 2 TRAJECTORIES WERE REALLY CLOSE TO MAYFIELD. CAMENBERT USED TO SOLVE ALMOST COLLISION. WHEN POSITIONED ON FIRST 3 LEFT TRAJECTORY, SURGEON USED AXIAL MODE TO POSITION. DURING THIS MONITOR WENT BLACK. 10 SECONDES. LATER MAIN MENU TO CREATE/LOAD FOLDER OR SHUT DOWN APPEARED. AFTER RELOADING FOLDER, SURGEON WANTED TO DOUBLE CHECK ACCURACY AND PLANED A TRAJECTORY ON A FIDUCIAL. ACCURACY WAS OK. REST OF PROCEDURE WENT WITHOUT ISSUES.

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 THAT DURING AN SEEG CASE, THE ROSA DISCONNECTED FROM THE CONTROLLER. THIS OCCURRED AFTER REGISTRATION WAS COMPLETE AND THE ROSA WAS AT THE HOME POSITION. THERE WAS NO OBVIOUS CAUSE TO THE ERROR. THERE WAS NO PATIENT IMPACT. THERE WAS AN HOUR DELAY TO THE CASE WHILE THE PATIENT WAS UNDER ANESTHESIA. THE CONTROLLER WOULD NOT RECONNECT AFTER MULTIPLE SHUTDOWNS, WITH UPWARDS OF 3 MINUTES OF POWER DOWN BEFORE RESTART. THE SOLUTION WAS DELETING THE 'SFTY.DAT' AND 'PDRV.DAT' FILES IN FTP SURFER FOR THE CONTROLLER.