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, AN UNSPECIFIED INSTRUMENT BROKE AND FRAGMENTS FROM THE INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME SURGERY. 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 MEDIASTINAL MASS REMOVAL PROCEDURE, THE CASE WAS CONVERTED TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON STATED HE PEELED THE TUMOR FROM THE HEART USING THE CADIERE FORCEPS AND THE SYNCHROSEAL INSTRUMENTS. AT THAT TIME, THE SURGEON INDICATED THAT HE "PUT A HOLE IN THE INNOMINATE VEIN" WITH THE SYNCHROSEAL INSTRUMENT. AS A RESULT, THE PATIENT EXPERIENCED BLEEDING. THE SURGEON IMMEDIATELY APPLIED PRESSURE WITH GAUZE USING THE SYNCHROSEAL INSTRUMENT (CLOSED JAWS) ON ARM 1. THE SURGEON CONFIRMED THE SYNCHROSEAL WAS NOT USED FOR SEALING AT THAT TIME. WHILE THE OR STAFF AND A RESIDENT WERE PLANNING THE CONVERSION, THE SYSTEM GENERATED A RECOVERABLE FAULT. AS A RESULT, THE SURGEON WAS UNABLE TO APPLY PRESSURE MOMENTARILY ON THE INJURED VESSEL UNTIL THE FAULT WAS RECOVERED. THE ASSISTANT RECOVERED THE FAULT WITHIN APPROXIMATELY 14-15 SECONDS, AND THE SURGEON WAS THEN ABLE TO CONTINUALLY APPLY PRESSURE ON THE INNOMINATE VEIN. HOWEVER, THE PATIENT BLED A LITTLE MORE DUE TO THE ADDITIONAL TIME IT TOOK TO RECOVER THE FAULT AND THEN THE PROCESS OF CONVERSION CONTINUED. ONC

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 INCISIONAL HERNIA REPAIR PROCEDURE WITH INTRAPERITONEAL ONLAY MESH (IPOM), THE SURGEON WAS HOLDING THE SMALL BOWEL WITH A CADIERE FORCEPS INSTRUMENT WHEN HE ACTIVATED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ON THE RIGHT ARM. AT THAT TIME, IT WAS NOTICED THAT THE SMALL BOWEL IN THE JAWS OF THE CADIERE FORCEPS INSTRUMENT HAD CHANGED COLOR AND WAS BURNED. AS A RESULT, THE SURGEON HAD TO PLACE SUTURES ON THE SMALL BOWEL TO ADDRESS THE BURN. ALTHOUGH THERE WAS NO ARCING OBSERVED FROM THE MCS INSTRUMENT, IT IS UNKNOWN WHAT CAUSED THE BOWEL BURN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON STATED HE HAD THE CADIERE FORCEPS INSTRUMENT INSTALLED ON THE LEFT ARM AND THE MCS INSTRUMENT INSTALLED ON THE RIGHT ARM. THE SURGEON WAS HOLDING THE SMALL BOWEL WITH THE CADIERE FORCEPS INSTRUMENT. THE SURGEON ACTIVATED THE MCS INSTRUMENT ON THE RIGHT ARM. AT THAT TIME, THE SURGEON NOTICED THE SMALL BOWEL IN THE JAWS OF THE CADIERE FORCEPS INSTRUMENT HAD CHANGED COLOR AND WAS BLANCHED (AS AN IMPRINT OF THE INSTRUMENT JAWS ON THE SMALL BOWEL). AS A RESULT, THE SURGEON HAD TO PLACE SUTURES

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 TOTAL GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER DISCOVERED THAT THE HARMONIC ACE INSTRUMENT BLADE WAS DAMAGED. THE HARMONIC ACE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGEON WAS DISSECTING TISSUE AT THE TIME OF THE EVENT. THE INSTRUMENT WAS IN USE FOR THIRTY MINUTES AND PERFORMED AS INTENDED UP UNTIL IT BROKE. AFTER THE BLADE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS VISUALLY LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND THERE WERE NO POST-OPERAT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE DURING INTRAOPERATIVE USE. AS A RESULT, A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN PIECE WAS RETAINED. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT. 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: ALL THE INSTRUMENTS AND ACCESSORIES WERE INSPECTED PRIOR TO USE AND NO DAMAGE OR ANY ABNORMALITY WAS FOUND. APPROXIMATELY AN HOUR WHEN TISSUE DISSECTION WAS BEING PERFORMED WHEN THE PIECE OF THE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE ENTIRE FALLEN PIECE WAS RETRIEVED USING ANOTHER INSTRUMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND REQUIRED. NO POST-SURGICAL COMPLICATIONS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE CUSTOMER FOUND A CRACK ON THE HARMONIC ACE INSTRUMENT JAW. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUE WAS NOTED. NO INSTRUMENT COLLISION WAS OBSERVED DURING THE PROCEDURE. THE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE SURGEON WAS MAKING AN INCISION AT THE TIME OF THE EVENT. THE INSTRUMENT PERFORMED AS INTENDED UP UNTIL IT BROKE. AFTER THE BLADE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS LOCATED AND RETRIEVED WITH LAPAROSCOPIC INSTRUMENT FORCEPS DURING THE SAME PROCEDURE. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS 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: INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5109522 ON (B)(6) 2022 AND THE FOLLOWING INFORMATION WAS PROVIDED: "DURING USE OF THE XI ROBOTIC SYNCHROSEAL INSTRUMENT, THE PLASTIC SHEATH COVERING TIP OF INSTRUMENT TORE OFF SHAFT OF INSTRUMENT AND WAS FOUND INSIDE PATIENT. SURGEON AND STAFF MEMBERS NOTICED PIECE OF INSTRUMENT INSIDE PATIENT. THE INSTRUMENT WAS REMOVED FROM SURGICAL USE AND DISLODGED PIECE WAS REMOVED FROM INSIDE PATIENT. BOTH INSTRUMENT AND PIECE WERE SAVED AND PLACED IN DIRTY UTILITY ROOM TO SENT BACK TO COMPANY FOR INSPECTION. FDA SAFETY REPORT ID# (8)(4). SYNCHROSEAL IS A BIPOLAR ELECTROSURGICAL INSTRUMENT FOR USE WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ELECTRO SURGICAL GENERATOR. IT IS INTENDED FOR GRASPING, DISSECTION, SEALING AND TRANSECTION OF TISSUE. SYNCHROSEAL CAN BE USED TO SEAL VESSELS UP TO AND INCLUDING 5 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. SYNCHROSEAL, WHEN USED WITH A COMPATIBLE ELECTROSURGICAL GENERATOR, CREATES A SEAL AND TRANSECTS TISSUE BY APPLICATION OF RADIOFREQUENCY (RF) ENERGY TO VESSELS AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. ELECTRODE SEALING SURFACES AND A CUT ELECTROD

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, A GRAY PIECE OF THE SYNCHOSEAL INSTRUMENT COMPLETELY FELL OFF INTO THE PATIENT. THE PIECE WAS REMOVED AND ANOTHER INSTRUMENT WAS USED AS A REPLACEMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING INFORMATION FROM THE SURGEON: FOR THE LYMPHADENECTOMY PROSTATECTOMY PROCEDURE, ALL FRAGMENTS WERE RETRIEVED AND WAS CONFIRMED VISUALLY. NO ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT AND NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON SUSPECTED THAT THE INSULATION WRAPPING SIMPLY HAD WEAR AND FELL OFF THE INSTRUMENT. THE SURGEON NOTED THAT THIS OCCURRED LESS THAN AN HOUR AFTER THE INSTRUMENT WAS FIRST USED. THE INSTRUMENT WORKED COMPLETELY FINE AND DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE. THE INSTRUMENT WAS REMOVED IMMEDIATELY AFTER THE FRAGMENT FELL. IT WAS NOTED THAT THERE WAS NO RESISTANCE IN THE CANNULA, THE INSTRUMENT WRIST WAS STRAIGHTENED, NO DAMAGE TO THE CANNULA HAD OCCURRED, AND THERE WAS NO OTHER DAMAGE TO THE INSTRUMENT. THERE WAS NO PATIENT INJURY 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: PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING A DA VINCI ROBOTIC DEVICE THAT WAS USED DURING A HERNIA REPAIR SURGERY ON (B)(6) 2022. PATIENT STATED SHE SPENT 4+ HOURS IN POST-OP AND THEY COULDN'T KEEP HER BLOOD PRESSURE STABLE. PATIENT SAID SHE KEPT PASSING OUT DUE TO LOSS OF BLOOD AND WAS HAVING INTENSE PAIN AT THE SURGICAL SITE. PATIENT STATED SHE REQUIRED AN EMERGENCY SURGERY TO EVACUATE THE BLOOD AND REATTACH THE MUSCLE THAT WAS DAMAGED DURING THE SURGERY. PATIENT SAID SHE SPENT SEVERAL DAYS IN THE ICU AND CONTINUES TO HAVE PAIN AND SWELLING DUE TO THE UNEXPECTED BLEED THAT OCCURRED AT THE SURGICAL SITE WHERE THE ROBOTIC DEVICE WAS USED. PATIENT SAID SHE IS NOW ANEMIC AND STILL CAN'T BEND OVER OR DO NORMAL DAY-TO-DAY ACTIVITIES AS SHE'S STILL HEALING FROM THE EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, AN UNKNOWN INSTRUMENT WAS OBSERVED TO HAVE A BROKEN PRONG. UPON INSERTION, A PRONG FELL OFF THE INSTRUMENT INTO THE PATIENT'S ABDOMEN. THE PIECE HAD TO BE REMOVED AND A NEW INSTRUMENT WAS THEN USED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS NOT ABLE TO PROVIDE WHAT TYPE OF INSTRUMENT HAD THE BREAKAGE ISSUE OR IF THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT BROKE IMMEDIATELY UPON INSERTION AND THE PIECE INTO THE ABDOMEN. ALL FRAGMENTS WERE RETRIEVED BY DIRECT VISUALIZATION. THE SURGEON WAS UNAWARE IF THE INSTRUMENT WILL BE RETURNED FOR ANALYSIS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE WHEEL HOLDING THE SHEATH OF THE SYNCHROSEAL INSTRUMENT CAME OFF AND FELL INTO THE PATIENT WHEN THE INSTRUMENT TOUCHED THE ENDOSCOPE. THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 19-MAY-2022: THE BROKEN WHEEL FELL ON THE DIGESTIVE TRACT AND WAS RETRIEVED WITH A LAPAROSCOPIC SURGICAL FORCEPS. IT WAS CONFIRMED THAT THE ENTIRE WHEEL WAS RETRIEVED AND NO ADDITIONAL POSTOPERATIVE TESTS WERE PERFORMED TO REMOVE IT. THE SURGEON BELIEVED THAT HE MIGHT HAVE HIT THE ENDOSCOPE WITH THE SYNCHROSEAL INSTRUMENT JUST BEFORE THE WHEEL WAS SEEN ON THE DIGESTIVE TRACT. THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR APPROXIMATELY 3 HOURS PRIOR TO ISSUE OCCURRED AND THE SURGEON WAS PERFORMING A HEPATECTOMY: SECTION OF THE LIVER. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY AND

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 14-MAR-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A "GASTROENTEROLOGY REPORT" JOURNAL ARTICLE TITLED, ¿ROBOTIC TOTAL GASTRECTOMY FOR CARCINOMA IN THE REMNANT STOMACH: A COMPARISON WITH LAPAROSCOPIC TOTAL GASTRECTOMY¿ (LI, Z., LIU, J., ET AL., 2021). THE PURPOSE OF THE ARTICLE WAS TO COMPARE THE EFFICACY AND SAFETY OF ROBOTIC TOTAL GASTRECTOMY (RTG) AND LAPAROSCOPIC TOTAL GASTRECTOMY (LTG) FOR THE TREATMENT OF CARCINOMA IN THE REMNANT STOMACH (CRS). A RETROSPECTIVE ANALYSIS OF DATA FROM PATIENTS WHO UNDERWENT RTG OR LTG FOR CRS AT A SPECIFIED HOSPITAL BETWEEN MAY 2006 AND OCTOBER 2019 WAS CONDUCTED. ALL SURGERIES WERE PERFORMED BY ONE SURGEON. THE SURGEON PERFORMED A TOTAL OF 27 ROBOTIC GASTRECTOMIES (RG). THE SURGICAL METHOD OF ROBOTIC VERSUS LAPAROSCOPIC WAS SELECTED BY EACH PATIENT. THE DA VINCI SURGICAL SYSTEM WAS USED FOR 29 PATIENTS. FIVE CASES IN THE RTG GROUP UNDERWENT CONVERSION TO OPEN SURGERY. THE REASONS FOR CONVERSION TO OPEN SURGERY IN THE ROBOTIC GROUP INCLUDED 3 CASES OF EXTENSIVE ADHESIONS, 1 CASE OF TUMOR INVASION TO THE TRANSVERSE COLON, AND 1 CASE OF TUMOR INVASION TO THE DIAPHRAGM. POST-OPERATIVELY, 1 PATIENT EXPERIENCED PNEUMONIA, 1 HAD AN INTRA-AB

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE METAL PIECE OF THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. SYNCHROSEAL IS A BIPOLAR ELECTROSURGICAL INSTRUMENT FOR USE WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ELECTRO SURGICAL GENERATOR. IT IS INTENDED FOR GRASPING, DISSECTION, SEALING AND TRANSECTION OF TISSUE. SYNCHROSEAL CAN BE USED TO SEAL VESSELS UP TO AND INCLUDING 5 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. SYNCHROSEAL, WHEN USED WITH A COMPATIBLE ELECTROSURGICAL GENERATOR, CREATES A SEAL AND TRANSECTS TISSUE BY APPLICATION OF RADIOFREQUENCY (RF) ENERGY TO VESSELS AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. ELECTRODE SEALING SURFACES AND A CUT ELECTRODE WITHIN THE JAWS ENABLE SEALING AND CUTTING. 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 RETROPERITONEAL PARTIAL NEPHRECTOMY, THE RENAL ARTERY WAS IDENTIFIED AND SKELETONIZED. THE SURGEON PLACED TWO SCANLAN BULLDOG CLAMPS (A 3RD-PARTY MANUFACTURER PRODUCT) ON THE RENAL ARTERY. FIREFLY WAS USED TO CONFIRM OCCLUSION OF THE ARTERY. HOWEVER, FIREFLY SHOWED THAT THE ARTERY WAS NOT PROPERLY OCCLUDED AND THE KIDNEY WAS STILL PERFUSED. AS A RESULT, THE SURGEON REMOVED THE SCANLAN BULLDOG CLAMPS AND PLACED UNSPECIFIED LAPAROSCOPIC CLAMP(S). ON 25-APR-2022, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION: DURING THE SURGICAL PROCEDURE, THE SURGEON CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE SP FENESTRATED BIPOLAR INSTRUMENT THAT WAS USED IN CONJUNCTION WITH THE SCANLAN BULLDOG CLAMPS. THE SURGEON EXPLAINED THAT AFTER PROPER SKELETONIZATION, THE SP BULLDOG CLAMPS WERE APPLIED AND THEN FIREFLY WAS TURNED ON. THE FIELD APPEARED GREEN. THE SURGEON STATED THAT HE FELT THE CLAMPING FORCE WAS INADEQUATE. THE SURGEON SWITCHED TO UNSPECIFIED LAPAROSCOPIC BULLDOG CLAMP(S) TO CONTINUE THE PROCEDURE WITH NO FURTHER ISSUES. THE SURGEON CONFIRMED THERE WAS NO ISSUE WITH ANY OF THE DA VINCI SP INSTRUMEN

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 11-MAR-2022, INTUITIVE BECAME AWARE OF A "TRANSLATIONAL LUNG CANCER RESEARCH" JOURNAL ARTICLE TITLED, ¿ROBOTIC-ASSISTED THORACIC SURGERY REDUCES PERIOPERATIVE COMPLICATIONS AND ACHIEVES A SIMILAR LONG-TERM SURVIVAL PROFILE AS POSTEROLATERAL THORACOTOMY IN CLINICAL N2 STAGE NON-SMALL CELL LUNG CANCER PATIENTS: A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL¿ (HUANG, J., TIAN, Y., ET AL., 2021). THIS STUDY WAS DONE TO EXPLORE THE LONG-TERM EFFICACY AND POTENTIAL BENEFIT IN SURVIVAL OF ROBOTIC-ASSISTED THORACIC SURGERY (RATS) COMPARED WITH LOBECTOMY IN CLINICAL N2 (C-N2) STAGE NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: POSTOPERATIVE COMPLICATIONS THAT OCCURRED IN THE RATS GROUP WERE PROLONGED AIR LEAK (7.9%) AND BRONCHOPLEURAL FISTULA. ADDITIONALLY, THE FOLLOWING COMPLICATIONS WERE OBSERVED AMONG THE PATIENTS IN THE RATS GROUP: 3 PATIENTS EXPERIENCED PNEUMONIA, 3 PATIENTS HAD ATRIAL FIBRILLATION, 3 PATIENTS HAD ATRIAL ARRHYTHMIA, 3 PATIENTS UNDERWENT CHEST TUBE INSERTION, 3 PATIENTS EXPERIENCED SUBCUTANEOUS EMPHYSEMA, 3 PATIENTS HAD CHYLOTHORAX, 2 PATIENTS EXPERIENCED HYPERPYRE

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 TOTAL BENIGN HYSTERECTOMY THE CUSTOMER OBSERVED A SMALL METAL RING ON TOP OF THE PATIENT'S UTERUS. THE RING WAS THOUGHT TO BE FROM THE SYNCHROSEAL INSTRUMENT THAT WAS IN USE AT THE TIME. THE RING WAS RETRIEVED, THE INSTRUMENT WAS REMOVED, AND A NEW SYNCHROSEAL INSTRUMENT WAS OPENED TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER. IT WAS CONFIRMED THAT THE METAL RING WAS RETRIEVED FROM THE PATIENT DURING THE SAME CASE. THE SURGEON VISUALLY CONFIRMED THAT THE METAL RING FROM THE INSTRUMENT WAS RETRIEVED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS ISSUE. NO OTHER 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION: THE SURGEON CLAIMED THAT THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY WHILE EXCISING TWO TUMORS ON THE INFERIOR AND SUPERIOR POLE OF THE KIDNEY. HE INITIALLY WORKED ON THE TUMOR ON THE INFERIOR POLE OF THE KIDNEY. THE SURGEON STATED THAT HE HAD SKELETONIZED THE RENAL ARTERY AND CLAMPED IT DOWN WITH THE SCANLAN BULLDOG CLAMP. HE MADE SURE HE CLAMPED IT WELL, AND THE TIP OF THE CLAMP WAS PAST THE ARTERY. HOWEVER, THE KIDNEY STILL WAS PERFUSED. AS A RESULT, THERE WAS AN ADDITIONAL 300CC OF BLOOD LOSS AND A POTENTIALLY HAZARDOUS DELAY IN THE PROCEDURE DURING WARM ISCHEMIA. THE TOTAL ISCHEMIA TIME AND THE ACTUAL EXTRA DELAY IN TIME WERE NOT PROVIDED. THE SURGEON THEN EXCISED THE TUMOR AND ADDRESSED THE BLEEDING WITH A FEW ADDITIONAL SUTURES. FOR THE SECOND TUMOR ON THE SUPERIOR POLE OF THE KIDNEY, THE SURGEON RECLAMPED THE RENAL ARTERY AGAIN WITH THE SCALAN BULLDOG CLAMP. HE CLAMPED APPROXIMATELY 4-5MM AW

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 COMPLETED SLEEP ENDOSCOPY + MODIFIED UVULOPHARYNGOPALATOPLASTY (UPPP) + TONSILLECTOMY, BILATERAL + (SINGLE PORT, SP) ROBOT ASSISTED EXCISION OF LESION OF TONGUE (GRADE 1) IN A PARTICIPANT OF THE SP-TRANSORAL ROBOTIC SURGERY (TORS) OBSTRUCTIVE SLEEP APNEA (OSA) STUDY, THE PATIENT DEVELOPED ORAL BLEEDING ON THE 9TH POST-OPERATIVE DAY (POD). THE BLEEDING WAS INITIALLY TREATED WITH ICE WATER GARGLING AND FASTING, BUT THE ORAL BLEEDING PERSISTED. A TONGUE BASE HEMATOMA WAS FOUND ON PHYSICAL EXAMINATION AND THE PATIENT UNDERWENT A SECOND PROCEDURE UNDER GENERAL ANESTHESIA TO LIGATE THE BLEEDING VESSEL. THE BLEEDING WAS FOUND TO BE OOZING. DUE TO THIS ADVERSE EVENT, THE HOSPITALIZATION OF THE PATIENT WAS PROLONGED. IT WAS NOTED BY THE SURGEON THAT BLEEDING AFTER PROCEDURES IS EXPECTED AND NORMAL FOR PATIENTS WITH OSA SURGERY, AND THIS EVENT WAS NOT CAUSED OR INDUCED BY A MEDICAL DEVICE MALFUNCTION OR USE. THE PATIENT RECOVERED AFTER THE SECOND PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE UPPP AND BILATERAL TONSILLECTOMY WAS CARRIED OUT VIA TRADITIONAL METHOD BY HAND. THE TONGUE WAS RESECTED

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 SLEEVE GASTRECTOMY THE CUSTOMER HAD ISSUES WITH THE FRAGMENT COMING OFF THE SYNCHROSEAL INSTRUMENT. CUSTOMER RETRIEVED FRAGMENT. INTUITIVE SURGICAL INC. (ISI) CONFIRMED THAT THE FRAGMENT CAME OFF THE DEVICE INTO THE PATIENT DURING PROCEDURE. THERE WERE NO POST-OPERATIVE COMPLICATIONS. THE SURGEON USED ANOTHER INSTRUMENT TO MANUALLY RETRIEVE THE FRAGMENT AND INSPECTED VISUALLY TO ENSURE FOREIGN MATERIAL WAS REMOVED. NO PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION OF AN ENERGY ISSUE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, A WASHER FROM THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE WASHER, BUT WAS NOT SURE IF A SCREW WAS ATTACHED TO THE WASHER. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED INJURY TO THE PATIENT. ON 16-FEB-2022, THE ROBOTICS COORDINATOR SENT INTUITIVE SURGICAL, INC. (ISI) PHOTOS OF THE INSTRUMENT AND THE WASHER. THE PHOTOS WERE FORWARDED TO FAILURE ANALYSIS ENGINEER (FAE) FOR REVIEW. FROM THE PHOTOS, FAE STATED IT LOOKED LIKE ALL COMPONENTS WERE RETRIEVED. THE PIVOT PIN WAS STILL WITHIN THE JAWS, AND THE WASHER DISLODGED AND WAS RETRIEVED IN ONE PIECE. ISI PASSED THE FAE'S INFORMATION TO THE CUSTOMER. ON 22-FEB-2022, ISI OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE ITEM (WASHER) WAS RETRIEVED IN THE SAME PROCEDURE. THEY USED A LAPAROSCOPIC GRASPER TO RETRIEVE THE WASHER. NO ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE ITEM. AN X-RAY WAS PERFORMED TO VERIFY THAT EVERYTHING WERE RETRIEVED. THE SURGEON BELIEVES THE INSTRUMENT BROKE DUE TO A PRODUCT MALFUNCTION. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING WAS O

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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND RETURNED TO THE FACILITY FOR TREATMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION. ON AN UNSPECIFIED POSTOPERATIVE DAY, THE PATIENT PRESENTED WITH HYPOTENSIVE SYMPTOMS. A CT SCAN REVEALED A HEMATOMA ON THE GREATER CURVE AREA. THE PATIENT HAD DEEP VEIN THROMBOSIS (DVT) AND A PULMONARY EMBOLISM. THE SURGEON STATED HE BELIEVES THE POST-OPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL, AND WAS RELATED TO THE SYNCHROSEAL INSTRUMENT USED ON THOSE VESSELS. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING. HE STATED HE DOES NOT LIKE HOW THE SYNCHROSEAL CUTS, AND HE HAS TO CUT THE VESSEL MORE THAN ONCE. THE SURGEON HAS NEVER HAD POST-OPERATIVE BLEEDING IN THE PAST, AND WILL REVERT TO USING THE VESSEL SEALER EXTEND INSTRUMENT. THE SURGEON CONFIRMED THAT THERE WAS NO SURGICAL INTERVENTION OR BLOOD TRANSFUSIONS RENDERED TO THE PATIENT. HOWEVER, THE PATIENT WAS HOSPITALIZED FOR IV FLUIDS, BLOOD WORK, CT SCAN AND OBSERVATION.

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 SURGICAL STAFF REALIZED THAT A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER WAS MISSING FROM THE MCS INSTRUMENT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED. THE CUSTOMER WAS REPORTEDLY SEARCHING FOR THE MCS TIP COVER AND THEY WAS QUESTIONING IF THE ITEM WAS RADIOLUCENT. THE CUSTOMER WAS INFORMED THAT THE ITEM WOULD NOT APPEAR IN AN X-RAY. ISI HAS PERFORMED MULTIPLE FOLLOW-UPS TO REQUEST ADDITIONAL INFORMATION RELATED TO THE EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

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 BLADE OF THE HARMONIC ACE CURVED SHEARS FELL OFF. THE FRAGMENT HAS BEEN LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. 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 THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY HAD WHITE FRAGMENTS SPATTERED AND SMOKE APPEARED WHILE USING THE ENERGY. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED. 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 OBSERVED. WHEN THE CUSTOMER STARTED TO USE THE INSTRUMENT, IT BROKE, AND SMOKE APPEARED AT THE INSTRUMENT TIP. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE BY SUCTION AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. IT WAS UNKNOWN WHAT CAUSED THE SMOKING EVENT AND THE BREAKAGE TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. 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 NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON F

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 OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AFTER A ¿BLADE PRESSURE¿ MESSAGE APPEARED. THE FRAGMENT THAT FELL INSIDE THE PATIENT WAS RETRIEVED DURING THE SAME PROCEDURE. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING 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 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 NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAG

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 OTHER URINARY DIVERSION SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL OFF THE INSTRUMENT AND INSIDE THE PATIENT'S BODY. THE MCS TIP COVER WAS RETRIEVED AND REPLACED WITH A NEW ONE; HOWEVER, THE SAME ISSUE OCCURRED AGAIN. THE CUSTOMER REPLACED THE MCS INSTRUMENT WITH A BACKUP AND THE MCS TIP COVER NO LONGER FELL OFF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A TOTAL CYSTECTOMY PERFORM ON (B)(6) 2022. AFTER THE FIRST MCS TIP COVER FELL INSIDE THE PATIENT'S BODY, THE SURGEON QUICKLY RETRIEVED IT WITH AN ASSISTANT FORCEPS. THEN, THE USER INSTALLED A NEW MCS TIP COVER ON THE MCS INSTRUMENT OUTSIDE OF THE PATIENT'S BODY BUT THE MCS TIP COVER SLIPPED OFF EASILY. THE MCS TIP COVER APPEARED TO BE INSTALLED PROPERLY WITH NO VISIBLE ORANGE SURFACE. THE MCS TIP COVER WAS NOT INSTALLED BEYOND THE ORANGE SURFACE THAT WOULD CAUSE A BULGE OVER THE SHAFT. NO INSTALLATION TOOL WAS USED. THE MCS INSTRUMENT WAS EXCHANGED OUT WITH A BACKUP. T

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 NEPHRECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) STATED THE CUSTOMER LOST THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE CSR WANTED TO KNOW IF THE MCS TIP COVER ACCESSORY WAS DETECTABLE BY X-RAY. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) INFORMED CALLER THAT THE MCS TIP COVER ACCESSORY WAS RADIOLUCENT AND THUS CANNOT BE DETECTED BY X-RAY. THE CSR STATED THAT NO INJURY WAS REPORTED AND THAT THE SYSTEM WAS FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED AS PLANNED. ON 31-JAN-2022, ISI OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. BOTH THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE USE AND NOTHING LOOKED OUT OF THE ORDINARY. THERE WAS NO DAMAGE ON EITHER ITEM. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE WITH A LAPAROSCOPIC INSTRUMENT. THERE WAS NO ISSUE WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT. A REDUCER WAS NOT USED FOR THIS INSTRUMENT. THE MCS TIP COVER ACCESSORY FELL OFF WHEN THEY WERE REMOVING THE INSTRUMENT, BUT THEY DID NOT FEEL ANY RESISTANCE WHEN IT WAS BEING REMOVED. SHE WAS NOT SURE IF T

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 25-JAN-2022, INTUITIVE SURGICAL, INC (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: "PATIENT WAS UNDERGOING A ROBOTIC ASSISTED LAPAROSCOPIC RIGHT NATIVE NEPHRECTOMY. THE SURGEON USED AN 8 MM SYNCHOSEAL CAUTERY/LIGATION DEVICE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED TO BE MISSING A SECTION OF THE GRASPER HOUSING. THE PROVIDER SEARCHED INSIDE THE PATIENT FOR THE FRAGMENT AND AN X-RAY WAS TAKEN. THE X-RAY DID NOT IDENTIFY ANY FOREIGN MATTER, BUT THE RADIOLOGIST NOTED PLASTIC WOULD NOT SHOW UP ON X-RAY." IT WAS ALSO REPORTED BY THE CUSTOMER TO INTUITIVE SURGICAL, INC. (ISI) THAT DURING A DA VINCI-ASSISTED RIGHT NATIVE NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTICED A MISSING SECTION OF THE SYNCRHOSEAL INSTRUMENT WHEN THEY REMOVED IT FROM THE PATIENT. THEY SEARCHED INSIDE THE PATIENT FOR THE FRAGMENT AND AN X-RAY WAS TAKEN. THE X-RAY DID NOT DETECT ANY FOREIGN MATTER, BUT THE RADIOLOGIST NOTED THAT PLASTIC WOULD NOT SHOW UP ON AN X-RAY. ON 04-FEB-2022, ISI CONTACTED ORIGINAL REPORTER FROM THE USER FACILITY REPORT AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT. SHE DID NOT KNOW HOW LONG THE INSTRUMENT WAS IN USE WHEN THE ISSUE OCCUR

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 JAW FROM A HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. ON 01-FEB-2022, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. THE FRAGMENT WAS RETRIEVED IMMEDIATELY AFTER IT BROKE OFF THE INSTRUMENT USING A LAPAROSCOPIC LOCKING GRASPER. NO POST-OPERATIVE TESTS WERE NEEDED AS THE FRAGMENT WAS LARGE ENOUGH TO SEE. SHE ESTIMATED THAT THE INSTRUMENT WAS IN USE BETWEEN 45 - 60 MINUTES. THE INSTRUMENT WAS INSPECTED BEFORE USE AND NOTHING WAS OUT OF THE ORDINARY. THE INSTRUMENT BROKE WHEN THEY WERE DISSECTING THE LIVER TISSUE. RIGHT BEFORE THE FRAGMENT BROKE, THEY RECEIVED A MESSAGE - RELAX PRESSURE ON JAWS. THERE WAS NO INSTRUMENT COLLISION AND THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD OBJECTS WHILE IN THE PATIENT. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A NEW HARMONIC INSTRUMENT. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES POST-SURGICAL PROCEDURE. THE INSTRUMENT AND FRAGMENT WAS GIVEN TO THE HOSPITAL RISK MANAGE

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 HARMONIC ACE INSTRUMENT¿S BLADE BROKE OFF WHILE THE SURGEON WAS MARKING LIVER TISSUE WITH OPENED JAWS. THE INSTRUMENT WAS ONLY IN USE FOR FIVE MINUTES. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 18-JAN-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE THE OPERATION. THE HARMONIC ACE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT DURING THE OPERATION. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPING FORCEPS. A REPLACEMENT INSTRUMENT WAS USED TO COMPLETE THE SURGERY. THE PATIENT DID NOT SUSTAIN ANY INJURIES AND DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE PATIENT¿S CURRENT HEALTH STATUS WAS REPORTED TO BE GOOD. NO POST-OPERATIVE EXAMINATIONS WERE PERFORMED TO LOCATE ANY REMAINING FRAGMENTS. NO PHOTO OR VIDEO WAS SENT TO ISI FOR REVIEW. THE PATIENT DEMOGRAPHICS, RELEVANT TESTS, AND RELEVANT HISTORY WERE NOT 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 THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT WAS SPOTTED RESTING ON THE PATIENT'S STOMACH ALONG THE STAPLE LINE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE BY A GRASPER INSTRUMENT. IT IS UNKNOWN WHEN THE INSTRUMENT BROKE. THEY FOUND THE FRAGMENT NEAR THE STAPLE LINE NEAR THE END OF THE PROCEDURE. THE SYNCHROSEAL DID NOT COLLIDE WITH ANOTHER INSTRUMENT OR HARD OBJECT WHILE INSIDE THE PATIENT. NO POST OPERATIVE TESTS WERE PERFORMED. THERE WAS NO REPORTED POST-OPERATIVE COMPLICATIONS. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE. THE INSTRUMENT AND FRAGMENT WILL BE RETURNED BACK TO ISI FOR EVALUATION.

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 SIGMOIDECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS BROKEN AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON JANUARY 20, 2022 INTUITIVE SURGICAL (IS) CONTACTED THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE FIRST ASSISTANT REMOVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. THE SURGICAL STAFF DOUBLE CHECKED THE PATIENT'S ANATOMY THEY WERE WORKING ON TO CONFIRM THAT NO FRAGMENT REMAINED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. IT WAS NOT NECESSARY TO PERFORM POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRA SOUND TO CHECK FOR REMAINING FRAGMENTS. AS PER THE SURGEON, THE CAUSE OF THE INSTRUMENT BREAKAGE IS UNKNOWN. THE INSTRUMENT WAS IN USE DURING THE WHOLE THE PROCEDURE. THE INSTRUMENT WAS INSPECTED BY THE NURSE BEFORE THEY HANDED IT TO THE SURGEON. NO DAMAGE WAS NOTICED. NO ISSUE OF THE INSTRUMENT FUNCTIONALITY NOTICED DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF INDICATED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER ONE DURING PROCEDURE. THE INSTRUMENT WAS REMOVED WITH N

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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ON POST-OPERATIVE DAY #1, THE PATIENT BECAME HYPOTENSIVE AND FELL. AS A RESULT, THE PATIENT ALLEGEDLY BROKE HER VERTEBRAE. THE PATIENT WAS TAKEN BY AMBULANCE TO A NEARBY HOSPITAL (DIFFERENT FROM THE HOSPITAL WHERE THE DA VINCI-ASSISTED SLEEVE GASTRECTOMY WAS PERFORMED). THE PATIENT WAS ADMITTED IN THE ICU. A CT SCAN REVEALED A HEMATOMA. AN ARTERIOGRAM CONFIRMED THERE WAS NO ACTIVE BLEEDING. THE PATIENT UNDERWENT A SECOND PROCEDURE FOR THE BROKEN VERTEBRAE. THE SURGEON REPORTED THAT HE BELIEVES THE POSTOPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL AND WAS RELATED TO AN ALLEGED INSUFFICIENT SEAL INVOLVING THE USE OF A SYNCHROSEAL INSTRUMENT. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING.

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 NEPHRECTOMY PROCEDURE THE ENDOSCOPE (SERIAL NUMBER (SN): (B)(4)) EXPERIENCED COMMUNICATION ISSUES WHEN INSTALLED. THE OPERATING ROOM STAFF RESEATED THE ENDOSCOPE WHEN THE ERRORS OCCURRED, BUT THE ISSUE PERSISTED. THE SITE POWER CYCLED THE SYSTEM, AND WHEN THE ENDOSCOPE WAS REINSTALLED THE ERRORS RETURNED. THE PATIENT BEGAN TO BLEED DURING THE TROUBLESHOOTING AND THE SITE CONVERTED TO OPEN RATHER THAN REPLACING THE ENDOSCOPE. THE PATIENT IS REPORTEDLY IN GOOD HEALTH AFTER THIS PROCEDURE. ON 19-JAN-2022, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE ENDOSCOPE ISSUES OCCURRED AT THE END OF THE PROCEDURE WHEN THE SURGEON WAS REMOVING THE TUMOR. THE PATIENT'S SPLEEN WAS SCRAPED AND ABOUT 50CC'S OF BLOOD WAS LOST IN TOTAL DUE TO THIS EVENT. THE SURGEON SAID THE BLEEDING WAS RESOLVED BY PLACING PRESSURE ON THE TISSUE.

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 DAVINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND RETURNED TO THE FACILITY FOR TREATMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION. ON AN UNSPECIFIED POSTOPERATIVE DAY, THE PATIENT PRESENTED WITH HYPOTENSIVE SYMPTOMS. A CT SCAN REVEALED A HEMATOMA. THE SURGEON STATED HE BELIEVES THE POST-OPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL AND WAS RELATED TO THE USE OF A SYNCHROSEAL INSTRUMENT ON THOSE VESSELS. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING. THE SURGEON STATED HE DOES NOT LIKE HOW THE SYNCHROSEAL CUTS AND HAS TO CUT THE VESSEL MORE THAN ONCE. THE SURGEON INDICATED THAT HE HAS NEVER HAD POST-OPERATIVE BLEEDING INCIDENTS IN HIS PREVIOUS PROCEDURES AND HENCE WILL REVERT TO USING THE VESSEL SEALER EXTEND INSTRUMENT. THE SURGEON CONFIRMED NO SURGICAL INTERVENTION OR BLOOD TRANSFUSIONS WERE RENDERED TO THE PATIENT. HOWEVER, THE PATIENT WAS HOSPITALIZED FOR IV FLUIDS, BLOOD WORK, CT SCAN, AND OBSERVATION.

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 DEVICE MANUFACTUER NARRATIVE 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 THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE THE TEFLON PAD MELTED, AND FRAGMENTS WERE FALLING INSIDE THE PATIENT. THE FRAGMENTS WERE NOT RETRIEVED. THE CUSTOMER REMOVED THE INSTRUMENT AND USED A BACKUP INSTRUMENT TO COMPLETE THE PROCEDURE. 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 OBSERVED. THE TEFLON PAD MELTED LIKE POWDER AS SOON AS THE CUSTOMER STARTED TO USE THE INSTRUMENT. THE FRAGMENTS WERE NOT RETRIEVED AS THEY WERE NOTED TO BE "LIKE POWDER." IT WAS UNKNOWN WHAT CAUSED THE MELTING TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS, AND THE CUSTOMER CONFIRMED THAT ARCING WAS NOT OBSERVED. THE THYROID TISSUE DID NOT APPEAR TO BE TOO THICK. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED, AND NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICA

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, HALF OF THE TIP FROM A HARMONIC ACE INSTRUMENT BROKE OFF IN THE ABDOMINAL CAVITY DURING LIVER RESECTION. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. THE SURGEON WAS USING THE HARMONIC ACE INSTRUMENT DURING A PARTIAL LIVER RESECTION. THE CASE WAS ALMOST COMPLETED, BUT THE FRAGMENT BROKE DURING DISSECTION. THE TEAM NOTICED THIS WHEN THE SURGEON WAS MOVING THE INSTRUMENT TO A DIFFERENT AREA OF THE LIVER. THIS CAUSED A 20-30 MINUTE DELAY IN THE CASE. THE FRAGMENT WAS FOUND AND REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE BY USING A LAPAROSCOPIC GRASPER. IT WAS CONFIRMED TO BE REMOVED VISUALLY SO NOT POST-OPERATIVE TESTS WERE NEEDED. BOTH THE FRAGMENT AND THE INSTRUMENT HAVE BEEN GIVEN TO RISK MANAGEMENT. THE CASE WAS LATER CONVERTED TO AN OPEN PROCEDURE DUE TO PATIENT ANATOMY AND NOT DUE TO THE MALFUNCTION OF THE INSTRUMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE PANCREAS WAS INJURED DURING THE INSERTION OF THE AIR-SEAL PORT IN A PATIENT WITH A SMALL BODY HABITUS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SOURCE OF BLEEDING WAS PANCREATIC TISSUE, WHICH WAS DAMAGED WHEN A THIRD-PARTY AIRSEAL PORT WAS INSERTED IN THE PATIENT. THE BLEEDING WAS INITIALLY STOPPED BY APPLYING COMPRESSION AND HEMOSTATIC POWDER. THE SURGEON BELIEVES THAT THE CAUSE OF THE PANCREATIC INJURY WAS DUE TO THE PETITE STATURE OF THE PATIENT AND THE CEPHALAD DIRECTION OF THE INSERTION OF THE AIRSEAL PORT. ACCORDING TO THE SURGEON, THERE WAS NO MALFUNCTION OF AN ISI PRODUCT THAT CAUSED THE PANCREATIC INJURY. AT THE END OF THE PROCEDURE, THE PANCREATIC INJURY, THAT WAS SUSTAINED DURING PORT PLACEMENT, BEGAN TO RE-BLEED. A HEPATOBILIARY PANCREATIC SURGEON WAS CALLED INTO THE OPERATION TO SUTURE THE PANCREAS TO ACHIEVE HEMOSTASIS. THE SURGEON BELIEVES THAT THE CAUSE OF THE RE-BLEEDING WAS DUE TO A PSEUDOANEURYSM FORMED DURING TISSUE DAMAGE, SUTURING, OR DECREASE IN THE INSUFFLATION PRESSURE. NO ADDITIONAL TISSUE RESECTION WAS REQUIR

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 ESOPHAGECTOMY TRANSTHORACIC-NECK ANASTOMOSIS SURGICAL PROCEDURE, A PIECE OF HARMONIC ACE INSTRUMENT BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER (NURSE) AND OBTAINED ADDITIONAL INFORMATION: THE CUSTOMER DID NOT NOTICE ANY DAMAGE ON THE INSTRUMENT PRIOR TO USE. THE BROKEN PIECE WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. 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.

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 HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS DISLODGED FROM THE MCS INSTRUMENT AND DROPPED IN THE CAVITY UPON REMOVING THE INSTRUMENT FROM THE PATIENT. THE SCRUB TECHNICIAN NOTICED THAT AND NOTIFIED THE SURGEON IMMEDIATELY. THE SCOPE WAS INTRODUCED AGAIN TO FIND AND RETRIEVE THE MCS TIP COVER ACCESSORY FROM THE BOWELS OF THE PATIENT. 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 ROBOTICS COORDINATOR STATED THAT THEY WERE ABLE TO REMOVE THE MCS TIP COVER WITH ANOTHER DA VINCI INSTRUMENT WITH NO REPOT OF PATIENT INJURY. THERE WERE NO INSTRUMENT FUNCTIONAL ISSUES AND THERE WAS NO ISSUE WITH REMOVING THE MCS FROM THE PATIENT. THEY NOTICED THE MCS TIP COVER ACCESSORY WAS NOT ON THE MCS THE MOMENT THEY REMOVED THE INSTRUMENT FROM THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE ISSUE. ELECTROLUBE WAS USED AFTER THE TIP COVER HAD BEEN INSTALLED; NOT PRIOR TO INSTALLATION. THE ROBOTICS COORDINATOR CLARIFIED THAT THEY ARE CONCERNED WITH USING THE MCS T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP CAME OFF OF THE MCS INSTRUMENT AND COULD NOT BE LOCATED. AN X-RAY WAS PERFORMED AND THE MCS TIP WAS NOT SEEN. THE INSTRUMENTS WERE REPORTEDLY INSPECTED PRIOR TO THE PROCEDURE AND NOTHING LOOKED OUT OF THE ORDINARY. THERE WAS NO COLLISION WITH ANY OTHER INSTRUMENT OR HARD MATERIALS DURING THE PROCEDURE. IT WAS UNKNOWN HOW LONG THE INSTRUMENT HAD BEEN IN USE WHEN THE ISSUE OCCURRED. ACCORDING TO THE NURSE, SHE AND THE SURGEON FELT THAT THE MCS TIP CAME OFF BECAUSE IT IS NOT ATTACHED TO THE INSTRUMENT AND SHOULD BE MORE SECURE. SHE MENTIONED THAT THE MCS TIP WAS VERY DIFFICULT TO INSTALL AND STATED THAT FUTURE DESIGNS SHOULD HAVE THE TIP PRE-INSTALLED. THE INSTRUMENT WILL NOT BE RETURNED FOR ANALYSIS SINCE THERE WAS NO INSTRUMENT ISSUE, AND THE MCS TIP CANNOT BE FOUND TO BE RETURNED. THE PATIENT HAS NOT RETURNED DUE TO ANY POST-SURGICAL COMPLICATIONS.

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 CUSTOMER NOTED THAT A SKILLED SURGEON ATTEMPTED TO USE THE HARMONIC ACE INSERT TO DISSOCIATE TISSUE, BUT THE BLADE WOULD NOT WORK. THE CUSTOMER REPLACED THE HARMONIC ACE INSERT WITH A BACK-UP DEVICE OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE BLADE OF THE HARMONIC ACE INSERT FELL INSIDE THE PATIENT AND WAS RETRIEVED IMMEDIATELY WITH OTHER INSTRUMENTS DURING THE SAME PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO ADDITIONAL SURGICAL INTERVENTION WAS CONDUCTED.

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 CASE IN PROGRESS WITH 45 MM STAPLER. STAPLER CLAMPED DOWN ON TISSUE AND WAS NOT ABLE TO DISCONNECT. SURGEON PRESSED EMERGENCY RELEASE BUTTON ON CONSOLE AND ASSIST USED EMERGENCY SCREW TO UNLOCK STAPLER FROM PATIENT WITH NO SUCCESS. DAVINCI REP CALLED AND CAME IN TO ASSIST. SURGEON WAS ABLE TO REMOVE STAPLER AND PROCEED WITH SURGERY. INSTRUMENT MALFUNCTION. WORKING WITH INTUIT REMOTELY, VENDOR WAS ABLE TO WORK WITH PHYSICIAN TO SUCCESSFULLY DISENGAGE STAPLER FROM BOWEL. INSTRUMENT WAS LABELLED AND REMOVED FROM SERVICE. VENDOR HAS SUBMITTED REQUEST FOR IR. A (B)(6) YEAR OLD MALE WITH QUADRIPLEGIA SUSTAINED AFTER DIVING INTO 3 FT OF WATER. HE UNDERWENT C4-5/6 ACDF WITH PLATING ON (B)(6) 2021. HE WAS INTUBATED FOR RESPIRATORY DISTRESS AND HAD TRACH PLACED (B)(6) 2021. PEG PLACED ON (B)(6) 2021. HIS HOSPITAL COURSE WAS COMPLICATED BY BRADYCARDIA WITH ASYSTOLE, NEUROGENIC SHOCK AND MUCUS PLUGGING. LAST COLONOSCOPY ~ 3 YEARS AGO, HE DOES HAVE A HISTORY OF COLON POLYPS, NO KNOWN FAMILY HISTORY OF COLON CANCER. HISTORY OF UMBILICAL HERNIA REPAIR WITH MESH MANY YEARS AGO. HE IS NOW AT A FACILITY FOR REHABILITATION. WE HAVE BEEN CONSULTED FOR COLOSTOMY TO HELP EASE CARE. HE WISHES TO

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 15-OCT-2021, INTUITIVE BECAME AWARE OF A JOURNAL OF GASTRIC CANCER ARTICLE TITLED, "INTRACORPOREAL ESOPHAGOJEJUNOSTOMY DURING REDUCED-PORT TOTALLY ROBOTIC GASTRECTOMY FOR PROXIMAL GASTRIC CANCER: A NOVEL APPLICATION OF THE SINGLE-SITE® PLUS 2-PORT SYSTEM" (CHOI, S., SON, T., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "ANASTOMOSIS-RELATED COMPLICATIONS WERE OBSERVED IN 2 PATIENTS. THE PATIENT WAS DISCHARGED ON POD 6 AFTER PROXIMAL GASTRECTOMY AND WAS RE-ADMITTED 14 DAYS AFTER DISCHARGE. THE PATIENT DEVELOPED ESOPHAGOJEJUNOSTOMY LEAKAGE, WHICH WAS TREATED WITH ENDOSCOPIC STENT INSERTION. ANOTHER PATIENT DEVELOPED ESOPHAGOJEJUNOSTOMY SITE STENOSIS THAT REQUIRED ENDOSCOPIC DILATATION DURING HOSPITALIZATION, AFTER WHICH THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY (POD) 29. THE OTHER PATIENT WHO UNDERWENT COMPLETION TOTAL GASTRECTOMY DEVELOPED AN INTESTINAL OBSTRUCTION THAT REQUIRED ADDITIONAL SURGERY (LAPAROSCOPIC SEGMENTAL RESECTION OF THE SMALL BOWEL), AFTER WHICH THE PATIENT WAS DISCHARGED ON POD 35." INTUITIVE SURGICAL, INC. (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 AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A 3RD DEGREE BURN WAS OBSERVED AROUND THE TROCAR SITE WHERE THE CAMERA PORT WAS LOCATED (3¿- 4¿ ABOVE THE UMBILICUS). THERE WAS NO ENERGY USED TO MAKE THE SURGICAL PORT INCISION AND NO REPORT OF ARCING OF ELECTRICAL ENERGY DURING THE CASE. IT WAS BELIEVED THAT BOTH THE PATIENT¿S ANATOMY AND THE DA VINCI INSTRUMENTS AND/OR ACCESSORIES MAY HAVE CONTRIBUTED TO THE BURN. THE PATIENT¿S UTERUS WAS ENLARGED AT 30 CM. IT IS ALLEGED THAT ALONG WITH THE PATIENT¿S SMALL STATURE AND MOVEMENT OF THE INSTRUMENTS DURING THE CASE, AN OCCLUSION MAY HAVE OCCURRED MAKING IT DIFFICULT FOR THE SMOKE TO EVACUATE. THE DA VINCI SYSTEM, INSTRUMENTS AND ACCESSORIES USED DURING THE PROCEDURE WERE INSPECTED PRIOR TO USE, AND NO ABNORMALITIES WERE FOUND. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED AT THE TIME OF THE EVENT. ALSO, THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE BURN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON REASSESSED THE INJURY AT THE PATIENT'S POST-OPERATIVE VISIT TWO WEEKS AFTER THE PROCEDURE. PER 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: 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.