da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC CLIP APPLIER NOT HOLDING CLIPS. FDA SAFETY REPORT ID # (B)(4).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN REGARD TO THE ARTICLE ¿EARLY FEASIBILITY SURVEILLANCE OF GYNECOLOGIC ROBOTIC-ASSISTED SURGERIES IN JAPAN¿ WRITTEN BY TSUKASA BABA, MASAKI MANDAI, HIROTAKA NISHI, OSAMU NISHII, JO KITAWAKI, MORIO SAWADA, KEIICHI ISAKA AND TOMOYUKI FUJII, AND PUBLISHED IN THE JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH, DR. TSUKASA BABA INDICATED THAT HE HEARD OF A COLLISION INDUCED RECTAL INJURY THAT OCCURRED ¿OUTSIDE OF VIEW.¿ DR. BABA INDICATED THAT HE WAS ¿NOT SURE [IF] THE PATIENT SUFFERED FROM SEPTIC SHOCK OR UNDERWENT ANASTOMOSE OR OTHER INTENSIVE CARE.¿ INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT, BUT AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN 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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, THE SURGEON HAD GRASPED UNSPECIFIED TISSUE WITH A HARMONIC ACE INSTRUMENT AND WAS NOT AWARE THAT THE INSTRUMENT HAD A BROKEN METAL PIECE. IT WAS ALSO NOTED THAT THERE WAS "EXCESSIVE BLEEDING" AND THE SURGICAL STAFF HAD DIFFICULTY CONTROLLING THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, THE SURGEON BELIEVES THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. ACCORDING TO THE INITIAL REPORTER, NO MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE BLEEDING AND THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. PER THE INITIAL REPORTER, THE PATIENT'S CURRENT STATUS WAS "RECOVERED." ON 10-AUG-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. THE CUSTOMER COULD NOT RECALL WHAT SPECIFIC TISSUE WAS INVOLVED WITH THE "EXCESSIVE BLEEDING." AFTER A TISSUE INCISION WAS MADE USING THE HARMONIC ACE INSTRUMENT, THE SURGEON ATTEMPTED TO USE THE COAGULATION FUNCTION. AT THAT TIME, THE CUSTOMER CLAIMED THAT THE INSTRUMENT DID NOT WORK AND BLEEDING OCCURRED. THE SURGEON WAS ABLE TO ACHIEVE HEMOSTASIS BY U

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

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

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SPLIT WAS EXTENDING INTO THE DARKER GRAY PLASTIC ON THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE DA VINCI COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE IN USE APPROXIMATELY FOUR HOURS INTERMITTENTLY, AND THEN A TEAR ON THE WAS NOTED ON THE MCS TIP COVER ACCESSORY. WHILE THE MCS INSTRUMENT WAS BEING REMOVED FROM THE PATIENT, THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT HAVING POSSIBLY GOTTEN CAUGHT ON THE CANNULA. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT. THERE WAS NO MCS INSTRUMENT FUNCTIONALITY ISSUE NOTED. IT IS UNKNOWN IF THE MCS INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS, IF THE SURGICAL STAFF FELT ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, OR IF THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE MCS

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 THYROIDECTOMY SURGICAL PROCEDURE, THE SURGEON WAS USING THE HARMONIC ACE BLADE TO DISSOCIATE THE TISSUE WHEN THE CURVED BLADE SEPARATED FROM THE INSTRUMENT INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND THE INSTRUMENT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, OR INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

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 BARIATRIC REVISION SURGICAL PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA NEAR THE AREA OF DISSECTION WITH A SYNCHROSEAL INSTRUMENT. INITIAL INFORMATION RECEIVED FROM THE REPORTER INDICATED THAT HE BELIEVED THIS WAS CAUSED BY THE SYNCHRO SEAL INSTRUMENT THAT WAS USED DURING A BARIATRIC ROBOTIC PROCEDURE. THE PATIENT REPORTEDLY HAD A SECOND (UNSPECIFIED) PROCEDURE TO ADDRESS THE HEMATOMA. IT WAS NOTED THAT THE INSTRUMENT WAS DISCARDED AS NO ISSUE WAS SUSPECTED FOLLOWING INITIAL PROCEDURE COMPLETION. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT AFTER UNDERGOING A SLEEVE GASTRECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED WITH NO ISSUE REPORTED. HOWEVER, POST-OPERATIVELY THE PATIENT HAD NOT BEEN ¿FEELING WELL¿ AND CALLED THE SURGEON TO REPORT IT. THE SURGEON RECOMMENDED THAT THE PATIENT COME INTO THE HOSPITAL. HOWEVER, THE PATIENT DECIDED TO GO TO ANOTHER HOSPITAL TO SEEK TREATMENT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A DIAGNOSTIC TEST CONDUCTED, WHICH INDICATED A POSSIBLE HEMATOMA. IT IS BELIEVED THAT THE PATIENT UNDE

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: IT WAS REPORTED THAT TWO PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT LEFT L3 AND RIGHT L4. INTRA-OPERATIVE IMAGING SHOWED THAT THE L3 SCREW WAS PLACED SUPERIOR IN THE DISC SPACE, AND THE L4 SCREW WAS LATERAL OF THE VERTEBRAL BODY. THE SCREWS WERE REMOVED AND PLACED USING NAVIGATED INSTRUMENTS BUT WITHOUT USE OF THE ROBOTIC ARM.

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 TWO PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN AT THE LS LEVEL. INTRA-OPERATIVE IMAGING SHOWED THAT THE SCREWS WERE PLACED THROUGH THE SUPERIOR ENDPLATES AND BORDERS OF THE PEDICLES. THE SCREWS WERE REMOVED AND PLACED WITHOUT USE OF THE SYSTEM.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY LOOSENED DURING USE. IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT AND WAS NOT RETRIEVED. 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.

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 THYROIDECTOMY SURGICAL PROCEDURE, THE SURGEON WAS USING THE HARMONIC ACE BLADE TO DISSOCIATE THE TISSUE WHEN THE CURVED BLADE SEPARATED FROM THE INSTRUMENT WHILE INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND THE INSTRUMENT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, OR INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED PRODUCT WAS INSPECTED PRIOR TO USE. ALL FRAGMENT(S) WERE RETRIEVED. THE ASSISTANT USED THE DA VINCI ENDOSCOPE TO SEARCH FOR THE FRAGMENT AND USED THE LAPAROSCOPIC INSTRUMENT TO GRASP THE FRAGMENT AND PULL IT OUT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. NO ISSUES WERE OBSERVED WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON DID NOT EXPERIENCE ANY ISSUES WITH REMOVING THE INSTRUMENT PRIOR TO THE BREAKAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE SYNCHROSEAL INSTRUMENT ARCED AT THE JAWS. THE SURGEON BELIEVED THAT IT WAS TRIGGERED BY A THICK, ROUND, LIGAMENT OF TISSUE. THE GENERATOR DID NOT SHUT OFF DUE TO THE REPORTED ARCING INCIDENT, BUT DAMAGE WAS NOTED BETWEEN THE JAWS OF THE INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY WITH NO REPORTED INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON, REGARDING THE REPORTED EVENT: THE SURGEON CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT WAS INSPECTED AT THE BEGINNING OF THE CASE AND NO DAMAGE WAS NOTED. THE ARCING EVENT WAS NOTED AFTER ABOUT FIVE MINUTES OF USE. THE SURGEON BELIEVED THAT THE ARCING EVENT OCCURRED DUE TO THE JAWS NOT CLOSING COMPLETELY ON A THICKER PORTION OF TISSUE. THE SURGEON CONFIRMED THAT THE INSTRUMENT WAS NOT REMOVED ANY TIME PRIOR TO THE ARCING EVENT. UPON REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. THE SURGEON CONFIRMED THAT THERE WAS NO PATIENT HARM, INJURY OR ADVERSE OUTCOME DUE TO THE REPORTED ARCING INCIDENT. THE SURGE

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 8MM MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THERE WAS NO REPORT OF PATIENT 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.

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 FOUR PEDICLE SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN USING THE, EXCELSIUS GPS SYSTEM, AT THE L3-4 LEVEL. INTRA-OPERATIVE IMAGING SHOWED THAT THE TWO LEFT SCREWS WERE PLACED MEDIALLY AND THE TWO RIGHT SCREWS WERE PLACED LATERALLY. THE SCREWS WERE REMOVED AND PLACED WITHOUT USE OF THE SYSTEM.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 AFTER UNDERGOING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A FEMALE PATIENT IN HER 70'S HAD AN ULTRASONOGRAPHY PROCEDURE PERFORMED ON THE VEINS IN A LOWER LIMB, IN ADDITION TO A ECHOCARDIOGRAPHY PROCEDURE AS A RESULT OF ELEVATED LEVELS OF SOLUBLE FIBRIN AND D-DIMER IN HER POST-OPERATIVE DAY #1 BLOOD SAMPLING. DEEP VEIN THROMBOSIS (DVT) WAS FOUND AND THE PATIENT WAS ALSO SUSPECTED TO HAVE A PULMONARY EMBOLISM. AS A RESULT, THE PATIENT WAS TREATED WITH ANTICOAGULANT THERAPY AND DISCHARGED ONE WEEK POST-OPERATIVELY. THE HOSPITAL COMMENTED THAT IT IS UNKNOWN IF THE POST-OPERATIVE COMPLICATIONS WERE DIRECTLY RELATED TO THE ROBOTIC SURGERY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 21-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE VIDEO IS NOT AVAILABLE FOR ISI TO REVIEW. NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THERE WERE NO CONVERSIONS TO TRADITIONAL LAPAROSCOPIC OR OP

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 AT THE CONCLUSION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A BURN INJURY TO THE SKIN ON THE PATIENT'S SACRUM WAS IDENTIFIED. ALTHOUGH THE BURN SEVERITY (DEGREE) WAS UNKNOWN, IT WAS NOTED THAT THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION DUE TO THE BURN INJURY. THE SURGEON/SITE DOES NOT BELIEVE AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE ALLEGED BURN INJURY. THE CUSTOMER REPORTEDLY USES SINGLE-USE DUAL-BLADE NEUTRAL PLATES (GROUNDING PADS) FOR COAGULATION, PLACING IT ON LEFT LEG FROM ABOVE. ON 07-APR-2020, ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE SKIN INTEGRITY OF THE PATIENT WAS NORMAL. IT WAS NOT THIN OR FRAIL. THE PATIENT HAD NO PRE-EXISTING SKIN CONDITIONS. IT WAS CONFIRMED TO BE A BURN INJURY TO THE PATIENT'S SACRUM. IT WAS A 1ST-2ND DEGREE BURN. THE BURN INJURY WAS REPORTED TO BE "10X20SM, RECTANGULAR, RED, WITH BLISTERS. THE PATIENT RECEIVED LOCAL SKIN TREATMENT AND WOUND DRESSING. THE SURGEON BELIEVED THAT THE BURN INJURY WAS DUE TO ¿NOT PROPER ISOLATION OF THE OPERATING TABLE.¿ THE GROUNDING PAD WAS CORRECTLY PLACED ON THE PATIENT'S LEFT LEG. IT WAS INSPECTED BEFORE

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2020, A MAKO TOTAL KNEE WITH TRIATHLON WAS IMPLANTED INTO THE PATIENT'S RIGHT KNEE USING PRODUCT/ROBOTIC ASSISTANCE, PINNING THE PRODUCT TO THE PATIENT'S FEMUR. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6) 2020, THE PATIENT'S FEMUR BROKE AS A DIRECT RESULT OF THE PRODUCT AND IMPLANTATION, AND HE UNDERWENT SUBSEQUENT SURGERY AS A RESULT OF HIS INJURIES.

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.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, VAIDA NAUSEDIENE, REPORTED THAT ON DAY 4, THE PATIENT DEVELOPED FEVER, SIGNS OF PERITONITIS. THE ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. ON (B)(6) 2020, PATIENT WAS RE-OPERATED VIA LAPAROTOMY, DISRUPTION OF ANASTOMOSIS, LAVAGE AND DRAINAGE OF THE ABDOMEN, END COLOSTOMY. PATIENT WAS THEN TREATED IN ICU, THUS POSTOPERATIVE COURSE AND RECOVERY WAS LONGER DUE TO INFECTION OF THE LAPAROTOMY WOUND, WITH OBESITY AND CO-MORBIDITIES PRESENT. PATIENT RECOVERED AND WAS DISCHARGED FOR A 20-MARCH-2020 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THE EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON 29-FEBRUARY-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 16-AUGUST-2023.

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 FOUR PEDIC/E SCREWS WERE NOT PLACED ACCORDING TO THE SCREW PLAN. INTRA-OPERATIVE IMAGING SHOWED THE SCREWS WERE PLACED MEDIALLY AND WERE OFF BY TWO VERTEBRAL LEVELS. THE SCREWS WERE REMOVED AND NEW ANTERIOR, POSTERIOR, AND LATERAL C­ ARM IMAGES WERE REGISTERED AND MERGED. USING THE EXCELSIUS GPS, THE SCREWS WERE CORRECTLY PLACED AT LS AND S1 ACCORDING TO THE INITIAL PLAN.

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 FOR FOLLOW-UP INFORMATION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOTIC EQUIPMENT MADE INCORRECT POSTERIOR CHAMBER CUT DURING SURGERY. FDA SAFETY REPORT ID# (B)(4).

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE LEFT LS SCREW WAS PLACED LOW TO PLAN. THE SCREW WAS REPOSITIONED INTRA-OPERATIVELY TO A NEW TRAJECTORY USING FLUOROSCOPIC IMAGING. IMMEDIATELY POST-OPERATIVE THE PATIENT HAD LIMITED MOVEMENT TO THE LOWER LEG AND FOOT. 28 DAYS LATER, THE SURGEON REPORTED THAT THE PATIENT HAD STARTED TO RECOVER MOVEMENT AND BELIEVED THIS IMPROVEMENT WOULD CONTINUE.

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 UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, DISSECTION OF THE VAGINAL STUMP WAS PERFORMED, AND TISSUE WAS DAMAGED. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE STUMP OF THE VAGINA WAS INJURED DURING THE PROCEDURE. THE CAUSE OF THE INJURY WAS ATTRIBUTED TO THE SURGEON¿S MISJUDGMENT. THE SURGEON CONFIRMED THAT ANOTHER STITCH SHOULD HAVE BEEN PLACED. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED TO REPAIR THE VAGINAL STUMP. ADDITIONALLY, THE SURGEON STATED THAT THE EVENT DID NOT OCCUR AS A RESULT OF THE DA VINCI SURGICAL SYSTEM MALFUNCTION. THE SURGERY WAS COMPLETED AS PLANNED AND THE PATIENT HAS PROGRESSED WELL WITHOUT ANY PROBLEMS.

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 VIA A GENERAL PHYSICIAN INQUIRY THAT AFTER A COMPLETED DA VINCI-ASSISTED GYNECOLOGY PROCEDURE, POSSIBLY ON (B)(6) 2019, PATIENT INJURY WAS REPORTED. THE PATIENT RETURNED TO THE HOSPITAL SIX TO SEVEN DAYS POST DA VINCI PROCEDURE, POSSIBLY ON (B)(6)2019, FOR WHAT WAS DESCRIBED AS ¿REPAIR¿ AS THERE WAS AN OBSERVED ¿TROCAR INJURY¿ AND ¿BOWEL NECROSIS¿. FURTHER DETAIL WAS UNKNOWN. THE PATIENT¿S CURRENT STATUS IS ALSO UNKNOWN.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE USING THE MAZOR NAVIGATION / ROBOTIC SYSTEM LEFT SIDE SCREWS OF A SPINAL FUSION WERE IN PLACE. THE RIGHT SIDED SCREWS WERE MEDIAL DISPLACED AND REQUIRED RE POSITIONING. FDA SAFETY REPORT ID# (B)(4).

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 SYSTEM PLACED SCREWS AT LL AND L4 ACCURATELY, BUT L2 AND L3 WERE WAY OFF. ACCORDING TO THE LOCAL TEAM, THE SURVEILLANCE WAS FINE AND THE MERGE WAS ACCEPTABLE. THE PATIENT IS DOING WELL BUT HAD A SMALL DURAL SCRATCH WHICH WAS REPAIRED INTRA-OPERATIVELY WITH NO SERIOUS LONG-TERM EFFECT TO THE PATIENT.

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 ALL OF THE SCREWS WERE NOT TO PLAN. ALL OF THE LEFT SIDE SCREWS WERE IN THE SPINAL CANAL AND THE RIGHT HAND SCREWS WERE LATERAL TO PLAN. PRIOR TO THE PROCEDURE, A 10 POINT ACCURACY CHECK WAS DONE AND THE GUIDANCE SYSTEM WAS ACCURATE ON ALL TRAJECTORIES. A SURGICAL ARM AND SHOULDER CHECK WERE ALSO DONE AND BOTH PASSED. THE TRAJECTORIES WERE PLANNED BY THE SURGEON AND THE C-ARM WAS CALIBRATED. THE GUIDANCE SYSTEM WAS PLACED ON THE BED AND DRAPED AS NORMAL. DURING THE PROCEDURE, EXPOSURE AND MARKING FILMS WERE DONE BEFORE THE SURGICAL SYSTEM WAS ATTACHED TO THE PATIENT. EXPOSE WAS GENEROUS AND THERE WERE NO ISSUE WITH SOFT TISSUE PRESSURE. A DUAL CLAMP WAS USED AT T4 AND T5. THE CONSTRUCT WAS RIGID BEFORE THE GUIDANCE SYSTEM WAS PLACED TO ATTACH TO THE CLAMP. A 3DEFINE SCAN AND DRAW SPINE WERE THEN COMPLETED. REGISTRATION WAS COMPLETED WITH TWO AP AND TWO OBLIQUE SHOTS. DURING IMAGING, RESPIRATION WAS SUSPENDED TO AVOID AN CROSS VIEW ERRORS. SEGMENTATION WAS ACHIEVED ON FIRST ATTEMPT AT LABELING AND ALL TRAJECTORIES WERE GREEN. REGISTRATION WAS APPROVED BY THE SURGEONS

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT IS REPORTED THAT DURING KNEE ARTHROPLASTY WHEN THE SURGEON WAS VALIDATING THE TIBIAL CUTS, THE SYSTEM WAS STATING THAT NOT ENOUGH WAS CUT PER THE PLAN AND THE ROD SHOWED BAD ALIGNMENT. THE SURGEON MADE ADDITIONAL CUTS TO BRING THE TIBIA INTO NEUTRAL ALIGNMENT WHEN HE SWITCHED TO CONVENTIONAL INSTRUMENTATION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON (B)(6) 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT. THIS PI IS FOR MULTIPLE I&D¿S WHILE HOSPITALIZED.

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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE STEALTH EDITION CAMERA UPGRADE WAS PERFORMED THIS PAST FRIDAY. THE 4.2 SOFTWARE HAD BEEN INSTALLED FOR A FEW MONTHS. STEALTH EDITION WAS NOT USED FOR THIS CASE. THE PATIENT WAS PLACED IN THE LATERAL POSITION FOR LATERAL PROCEDURE WITH THE LEFT SIDE UP. A SCHANZ PIN WAS PLACED IN LEFT PSIS AND 3DEFINE ATTEMPT WAS SUCCESSFUL. THE ARM WAS THEN SENT TO DRAPE FOR DRAW SPINE, BUT AN ERROR MESSAGE INDICATED THAT DRAPE POSITION WAS UNREACHABLE. THE 3D WORKING VOLUME WAS THOUGHT TO HAVE BEEN THE REASON FOR THIS. THE ARM WAS REMOUNTED WITH THE ELBOW JOINT ANGLE ADJUSTED SLIGHTLY. THE SECOND 3DEFINE WAS SUCCESSFUL AND THE ARM WAS SUCCESSFULLY SENT TO DRAPE MODE. DRAW SPINE WAS SUCCESSFUL. 3D MARKER SENT TO AP. THE 3D MARKER WAS ADJUSTED ANTERIOR TO BETTER CAPTURE THE AP. ERROR 295 APPEARED WHEN ATTEMPTING TO SEND THE ARM TO TAKE OBL IMAGE: ¿OBL POSITION IS UNREACHABLE. CONSIDER RE-DRAWING SPINE USING A DIFFERENT VERTEBRAL BODY.¿ THE ARM WAS MANIPULATED POSTERIOR AND THEN SUCCESSFULLY SENT TO THE OBL I

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 INITIAL KNEE SURGERY, METAL SHAVINGS WERE NOTICED WHEN DRILLING A TROCHAR PIN THROUGH ONE OF THE HOLES OF THE CUT GUIDE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION REPORTED.

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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON PERFORMED AN L3-5 LATERAL MAZOR X CASE. PREPLANNING WAS DONE WITH THE SURGEON PRIOR TO THE PROCEDURE. SPECIAL ATTENTION WAS PAID TO AXIAL ANGLES AND SKIVE POTENTIALS. L3-5 OLIF WAS PERFORMED PRIOR TO USING THE MAZOR X. THE PATIENT WAS POSITIONED FOR A LATERAL PROCEDURE. THE SCHANZ PIN WAS PLACED IN LEFT PSIS. AND THE SCHANZ ARM WAS ATTACHED. 3DEFINE AND DRAW SPINE WERE SUCCESSFUL. REGISTRATION WAS SUCCESSFUL USING AUTO REGISTRATION AND THE BASIC ALGORITHM. ALL 6 WIRES WERE PLACED STARTING WITH RIGHT L3. ALL RIGHT SIDE TRAJECTORIES WERE INSTRUMENTED PRIOR TO LEFT SIDE TRAJECTORIES. LATERAL CONFIRMATION FLOURO IMAGES WERE TAKEN FOR EACH TRAJECTORY AND APPEARED ACCURATE. A FINAL AP CONFIRMATION SHOWED RIGHT L3 WAS LATERAL. RIGHT L3 WAS ADJUSTED IN THE PLAN AND DRILLED AGAIN. FINAL AP AND LATERAL FLOURO IMAGES WERE TAKEN AND ALL 6 SCREWS APPEARED TO BE PLACED ACCURATELY. THE POST-OP CT SHOWED LEFT SIDE SCREWS MISPLACED MEDIALLY AND RIGHT SIDE SCREWS MISPLACED LATERALLY. UPON CASE COMPLE

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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PLAN FOR THE CASE WAS TO PERFORM A SCAN AND PLAN AND EXECUTE SCREWS AT T11, T12, L2, AND L3. THIS WAS TO BACK UP A L1 BURST FRACTURE. ONCE THE SURGEON EXPOSED THE REGION OF INTEREST, THE REP SUGGESTED USING THE DUAL CLAMP AND CLAMPING AT T12 AND L2 SPINOUS PROCESSES. THIS WAS TO AVOID THE INSTABILITY OF L1. THE DUAL CLAMP WAS PLACED, 3DEFINE PERFORMED, SNAPSHOT TAKEN AND THEN STAR MARKER PLACED. DUE TO THE SIZE OF THE PATIENT AND HEIGHT OF THE DUAL CLAMP, IT TOOK THREE SPINS OF THE O-ARM TO ACHIEVE REGISTRATION. SCREWS WERE THEN PLANNED AND REVIEWED WITH THE SURGEON. THORACIC SCREWS WERE PLANNED BETWEEN 8-10 DEGREES OFF MIDLINE TO ACCOUNT FOR ANY SOFT TISSUE PROBLEMS, WITH LUMBAR SCREWS PLANNED SLIGHTLY MORE LATERAL. THE REP NOTED THE SMALL PEDICLES TO THE SURGEON AND ASKED IF THEY WOULD LIKE TO ADJUST TO 4.5MM SCREWS AND THEY OPTED TO KEEP THEM AT 5.5MM. THE SCREWS WERE THEN EXECUTED STARTING WITH T11 ON THE RIGHT AND WORKING DOWN, FOLLOWED BY T11 ON THE LEFT AND WORKING DOWN. NAVIGATION S

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT HAD A RIGHT MAKO THA SURGERY ON (B)(6) 2019. SHE STARTED TO EXPERIENCE DRAINAGE FROM INCISION APPROX. (B)(6) 2019. THE INCISION OPENED ON (B)(6) 2019, PATIENT WENT TO THE ER AND WAS ADMITTED. PATIENT WAS PARTIALLY REVISED ON (B)(6) 2019. PATIENT WAS DISCHARGED A WEEK AFTER REVISION AND WAS GIVEN ANTIBIOTICS. ON (B)(6) 2019 PATIENT WENT FOR A FOLLOW-UP VISIT AND WAS TOLD TO FOLLOW UP WITH HER ORIGINAL SURGEON. PATIENT WENT TO SEE THE ORIGINAL SURGEON THE SAME DAY AND WAS ADMITTED TO THE HOSPITAL. DURING HER HOSPITAL STAY, MULTIPLE I&DS WERE PERFORMED APPROX. ON (B)(6) 2019, (B)(6) 2019 AND ON (B)(6) 2019. PATIENT WAS DISCHARGED ON (B)(6) 2019. PATIENT CONTINUED TO EXPERIENCE DRAINAGE AFTER BEING DISCHARGED. ALL COMPONENTS WERE REVISED ON (B)(6) 2019 AND A CEMENT SPACER WAS PLACED. ANOTHER I&D WAS PERFORMED ON (B)(6) 2019 AND WAS PLACED IN REHAB. ON (B)(6) 2019 THE SPACER WAS REMOVED, AND PATIENT WAS IMPLANTED WITH COMPETITOR PRODUCT. THIS PI IS FOR REVISION OF 1ST REVISION.