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: ON 03-SEP-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE, VIA AN ISI CLINICAL JOURNAL REVIEW, OF A JOURNAL HERNIA ARTICLE TITLED ¿COMPARISON OF PERIOPERATIVE OUTCOMES BETWEEN NON-OBESE AND OBESE PATIENTS UNDERGOING ROBOTIC INGUINAL HERNIA REPAIR [RIHR]: A PROPENSITY SCORE MATCHING ANALYSIS¿ (KUDSI, O. Y., BOU-AYASH, N., ET AL., 2021). A SINGLE-CENTER, ¿TEACHING COMMUNITY HOSPITAL,¿ RETROSPECTIVE REVIEW OF COLLECTED DATA SURROUNDING RIHR PROCEDURES WAS PERFORMED WITH THE STUDY PERIOD BEING BETWEEN FEBRUARY 2013 AND AUGUST 2020. PATIENTS WERE DIVIDED INTO NON-OBESE (< 30 KG/M2) AND OBESE (= 30 KG/M2) GROUPS. OF A TOTAL OF 547 PATIENTS, 414 WERE NON-OBESE AND 133 WERE OBESE. SURGICAL TECHNIQUE: ROBOTIC TRANSABDOMINAL PRE-PERITONEAL (RTAPP) INGUINAL HERNIA REPAIR: AFTER APPROPRIATE PREPARATION, A VERESS NEEDLE [NON-ISI PRODUCT] INSERTED INTO THE LEFT UPPER QUADRANT WAS USED TO ESTABLISH PNEUMOPERITONEUM. THREE 8.5 MM TROCARS WERE INSERTED 8 CM APART AND 4 CM ABOVE THE UMBILICUS LEVEL. THE PATIENT SIDE CART OF THE DA VINCI SURGICAL ROBOTIC SYSTEM (INTUITIVE SURGICAL, SUNNYVALE, CA) WAS DOCKED. POLYESTER MESH MATERIAL WAS USED. WITHIN THE JOURNAL ARTICLE, COMPLICATIONS WERE NOTED: "IN

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: ON 29-AUG-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A SCIENTIFIC REPORTS ARTICLE TITLED, ¿COMPARISON OF SHORT-TERM SURGICAL OUTCOMES USING DA VINCI S, SI AND XI SURGICAL SYSTEM FOR ROBOTIC GASTRIC CANCER SURGERY¿ (OJIMA, T., NAKAMURA, M., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI XI SURGICAL PROCEDURE WAS NOTED: A (B)(6) YEAR OLD MALE UNDERWENT A DA VINCI-ASSISTED DISTAL GASTRECTOMY PROCEDURE. THE PROCEDURE WAS CONVERTED TO OPEN DUE TO A "PORTAL VEIN INJURY." IT WAS REPORTED THAT THE PATIENT LOST 2540 ML OF BLOOD DURING THIS PROCEDURE AND NO POST-OPERATIVE COMPLICATIONS OCCURRED. THE PROCEDURE WAS A TOTAL OF 598 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: ON 02-SEP-2021, DURING AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL JOURNAL REVIEW, INTUITIVE BECAME AWARE OF A SURGICAL ENDOSCOPY ARTICLE TITLED, ¿ROBOTIC TRANSAXILLARY LATERAL NECK DISSECTION FOR THYROID CANCER: LEARNING EXPERIENCE FROM 500 CASES¿ FROM JANUARY 2008 TO JULY 2019 WHEREBY WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS AFTER DA VINCI SURGICAL PROCEDURES WERE NOTED: TRANSIENT HYPOCALCEMIA WAS THE MOST COMMON COMPLICATION (30.4%), FOLLOWED BY CHYLE LEAKAGE (5.2%), PERMANENT HYPOCALCEMIA (4.0%), TRANSIENT HOARSENESS (4.0%), AND SEROMA FORMATION (3.2%). FIVE (1.0%) PATIENTS HAD A PERMANENT RLN INJURY, AND THE NERVE WAS SACRIFICED DUE TO CANCER INVASION IN ONE PATIENT. THREE (0.6%) PATIENTS HAD HEMATOMA FORMATION, AND ONE OF THEM (0.2%) UNDERWENT BLEEDER LIGATION. TWO (0.4%) PATIENTS DEVELOPED HORNER¿S SYNDROME." THE JOURNAL ARTICLE CITED THAT, ¿FOLLOWING THE SURGERY, ALL PATIENTS RECEIVED LEVOTHYROXINE FOR THYROID-STIMULATING HORMONE (TSH) SUPPRESSION. ALL PATIENTS UNDERWENT RADIOACTIVE IODINE (RAI) ABLATION (3.7¿5.5 GBQ), POST-THERAPY WHOLE-BODY SCANS, AND DIAGNOSTIC WHOLE-BODY SCANS.¿ THE JOURNAL ARTICLE CITED THE FOLLOWING: "THIS STUDY AIMED TO DEMONSTRATE THE TECH

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: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ANNALS OF TRANSLATIONAL MEDICINE ARTICLE TITLED, ¿RISK FACTORS FOR LYMPH NODE METASTASIS OF THE LEFT RECURRENT LARYNGEAL NERVE IN PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA¿ (CHEN, C., MA, Z., SHANG, X. ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "THERE WERE 6 CASES WITH VOCAL CORD PARALYSIS (16.38%), 3 WITH ANASTOMOTIC LEAKAGE (3.19%), AND 10 WITH PULMONARY INFECTION (10.64%) AFTER ESOPHAGECTOMY." ADDITIONAL INFORMATION OBTAINED FROM THE JOURNAL ARTICLE: THIS WAS A RETROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT MCKEOWN MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) (NO NEOADJUVANT THERAPY) AT TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL (FROM JANUARY 2016 TO DECEMBER 2019). DA VINCI ROBOT-ASSISTED (DA VINCI SI/XI) AND THORACIC LAPAROSCOPIC VIDEO-ASSISTED MIE WERE PERFORMED IN 3 STAGES. FIRST, THORACOSCOPY OR THE DA VINCI ROBOT WAS USED TO MOBILIZE THE ESOPHAGUS AND DISSECT THE THORACIC LNS IN THE PRONE POSITION WITH THE RIGHT HAND HOLDING THE HEAD. SECOND, THORACOSCOPY OR THE DA VINCI ROBOT WAS USED TO CREATE THE GASTRIC CONDUIT AND DISSECT THE ABDOM

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 30-AUG-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A UPDATES IN SURGERY ARTICLE TITLED, ¿IMPACT OF BODY MASS INDEX ON THE EARLY EXPERIENCE OF ROBOTIC PANCREATICODUODENECTOMY¿ (CHAO, Y. J., LIAO, T. K., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "ALL OPERATIONS WERE PERFORMED USING THE DA VINCI SI SURGICAL SYSTEM. TWO PATIENTS (2.9%) WERE CONVERTED TO OPEN SURGERY IN THE OBESE GROUP DUE TO SEVERE INFLAMMATION AT THE PANCREATIC HEAD AND TUMOR ADHESIVE TO THE SUPERIOR MESENTERIC VEIN AND NONE IN THE NORMAL-WEIGHT AND OVERWEIGHT GROUPS. THIRTY THREE PATIENTS EXPERIENCED COMPLICATIONS WITH AN OVERALL COMPLICATION RATE OF 51.5%, AND THE MAJOR COMPLICATION RATE (CLAVIEN GRADE = III) WAS 19.1%. THERE WERE 17.6% CLINICALLY RELEVANT POST-OPERATIVE PANCREATIC FISTULA (CR-POPF) (16.1% GRADE B POPF, 1.5% GRADE C POPF), 8.9% GRADE B/C POST PANCREATECTOMY HEMORRHAGE (PPH), 11.8% GRADE B/C DELAYED GASTRIC EMPTYING (DGE), AND 5.9% BILE LEAKAGE. TWELVE PATIENTS (17.6%) HAD PERIPANCREATIC FLUID COLLECTIONS, AND EIGHT OF THEM REQUIRED DRAINAGE. ONE PATIENT REQUIRED REOPERATION DUE TO FAILED EMBOLIZATION OF THE PSEUD

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 TRANSLATIONAL ANDROLOGY AND UROLOGY ARTICLE TITLED, ¿ROBOT-ASSISTED LAPAROSCOPIC RETROPERITONEAL LEIOMYOSARCOMA RESECTION WITH INFERIOR VENA CAVA GRAFT REPLACEMENT: A CASE REPORT¿ (CHENG, G., RUAN, H., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "OWING TO THE UNEXPOSED SIGHT OF RIGHT RENAL ARTERY, THE ACCIDENTAL INJURY OCCURRED INTRAOPERATIVELY AND THUS THE PATIENT SUFFERED FROM RIGHT RENAL INSUFFICIENCY WITH LOWER GFR RATE." ADDITIONAL INFORMATION OBTAINED FROM THE ARTICLE: THE ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS ABOUT 2,000 ML AND THE PATIENT WAS TRANSFUSED BLOOD PLASMA WITH 600 ML INTRAOPERATIVELY. THE PATIENT WAS GIVEN AN INFUSION OF HEPARIN (AN ANTICOAGULANT) INTRA-OPERATIVELY. MRI DONE AT 1 WEEK POST-OPERATIVELY SHOWED THAT THE CONTINUITY OF RIGHT RENAL ARTERY IMAGING WAS INTERRUPTED AND SIGNALING OF THE RIGHT KIDNEY WAS WEAKER THAN THE LEFT ONE, WHICH IMPLIED STRICTURE OF RIGHT RENAL ARTERY. DURING THE 3-MONTH FOLLOW-UP OF THE PATIENT, DYNAMIC RENOGRAPHY REVEALED THAT GFR OF THE RIGHT KIDNEY WAS SIGNIFICANTLY DECREASED TO 27.4 ML/MIN, WHICH IND

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: ON 08/29/2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A RETROSPECTIVE OBSERVATIONAL STUDY ARTICLE, VIA AN ISI CLINICAL JOURNAL REVIEW, FROM THE ¿JOURNAL OF ROBOTIC SURGERY¿, TITLED, ¿ROBOTIC ABDOMINAL WALL REPAIR: ADOPTION AND EARLY OUTCOMES IN A LARGE ACADEMIC MEDICAL CENTER¿ (PEREIRA, X., LIMA, D. L., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A ¿ROBOTIC-ASSISTED¿ PROCEDURE WAS NOTED. THE JOURNAL ARTICLE CITED, IN A ¿RETROSPECTIVE REVIEW OF ALL PATIENTS UNDERGOING ANY RAWR FROM JULY 1, 2016 TO MARCH 18, 2020¿, THAT DURING A ROBOTIC-ASSISTED ABDOMINAL WALL REPAIR (RAWR). THE JOURNAL ARTICLE CITED THAT THIS STUDY WAS CLASSIFIED BY SURGICAL MODALITY AS EITHER OPEN, LAPAROSCOPIC, OR ROBOTIC HERNIA REPAIR, OF 312 PATIENTS INCLUDED IN THE REVIEW, THERE WERE TWO REPORTED INTRAOPERATIVE EVENTS AND NINE OPERATIVE CONVERSIONS. 60 PATIENTS HAD AT LEAST ONE COMPLICATION AT 30 DAYS, AND THERE WAS ONE MAJOR INTRAOPERATIVE EVENT REQUIRING A DEVIATION OF THE PLANNED SURGERY AND PROLONGED ADMISSION. OF THE TWO ¿REPORTABLE INTRAOPERATIVE EVENTS: ONE REQUIRED A CHANGE IN THE INITIAL OPERATIVE PLAN AND HAD A HISTORY OF CIRRHOSIS AND CONTROLLED PORTAL HYPER

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: ON 08/28/2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A WORLD JOURNAL OF UROLOGY ARTICLE TITLED, ¿NEW TECHNIQUE OF ROBOT-ASSISTED LAPAROSCOPIC ARTIFICIAL URINARY SPHINCTER IMPLANTATION IN FEMALE BY A POSTERIOR APPROACH WITH INTRAOPERATIVE CYSTOSCOPIC MONITORING¿ (BROUDEUR, L., LOUBERSAC, T., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: "TWENTY-FOUR PATIENTS WERE INCLUDED, THE MEDIAN AGE WAS 66 YEARS, 23/24 (96%) HAD PREVIOUS STRESS URINARY INCONTINENCE (SUI) OR PROLAPSE SURGERY. TWO CONVERSIONS TO OPEN SURGERY DUE TO MAJOR PELVIC ADHESIONS AND POOR RESPIRATORY TOLERANCE TO PNEUMOPERITONEUM. 2 PATIENTS UNDERWENT MODIFICATIONS OF THE SURGICAL TECHNIQUE WITH ANTERIOR DISSECTION OF THE BLADDER NECK DUE TO MAJOR VESICOVAGINAL ADHESIONS. OVERALL, 20 PATIENTS UNDERWENT THE ROBOTIC POSTERIOR APPROACH. ELEVEN INTRAOPERATIVE COMPLICATIONS IN 10 PATIENTS (50%) OCCURRED, INCLUDING 7 BLADDER INJURIES , 4 VAGINAL INJURIES, WITHOUT THE NEED TO STOP THE PROCEDURE. THE MEDIAN HOSPITAL STAY WAS 3 DAYS (2¿7). ONE ARTIFICIAL URINARY SPHINCTER (AUS) WAS REMOVED AT 1 YEAR DUE TO VAGINAL EROSION." ISI MADE MULTIPLE FOLLOW-UP

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE HARMONIC ACE INSTRUMENT BROKE AND THE INSTRUMENT TIP WAS MISSING. THE SITE WAS CONTINUING THE PROCEDURE AS PLANNED AT THAT TIME. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE DA VINCI COORDINATOR AT THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2021. THE FRAGMENT FROM THE HARMONIC ACE INSTRUMENT WAS RETRIEVED MANUALLY BY THE SURGEON AFTER THE PROCEDURE WAS COMPLETED. AN X-RAY WAS PERFORMED, BUT THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO RETRIEVE THE FRAGMENT. THE INSTRUMENT WAS IN USE FOR AN UNKNOWN AMOUNT OF TIME BEFORE THE ISSUE OCCURRED AND IT WAS UNKNOWN IF THE HARMONIC ACE WAS INSPECTED PRIOR TO USE. THERE WAS NO INSTRUMENT COLLISION AND THE INSTRUMENT WAS REMOVED THROUGH THE CANNULA WITH THE WRIST STRAIGHTENED. THE CAUSE OF THE INSTRUMENT BREAKAGE WAS NOT KNOWN. THERE WAS NO REPORT OF PATIENT INJURY AS A RESULT OF THE ISSUE. ALTHOUGH THE INSTRUMENT WAS REQUESTED TO BE RETURNED FOR ANALYSIS, THE CUSTOMER WAS UNSURE IF IT WOULD BE RETURNED. NO IMAGES OR PROCEDURE VIDEOS WERE AVAILABLE FOR REVIEW.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS ORIGINALLY REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BENT TO THE LEFT AND COULD NOT BE REMOVED THROUGH THE CANNULA. THE MCS INSTRUMENT AND THE CANULA WERE REMOVED TOGETHER FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT FRAGMENTS FROM THE MCS TIP COVER ACCESSORY WERE MISSING AND HAD FALLEN INSIDE THE PATIENT. THE SURGEON LOCATED AND RETRIEVED TWO FRAGMENTS, BUT THEY DID NOT EQUAL THE SIZE OF THE PIECE THAT WAS MISSING FROM THE MCS TIP COVER ACCESSORY. THE LOCATION OF THE MISSING FRAGMENT(S) WAS UNKNOWN. ON 30-SEPTEMBER-2021, ISI CONTACTED THE ROBOTICS COORDINATOR (THE ORIGINAL REPORTER) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE EVENT. THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE THE PROCEDURE AND THERE WAS NOTHING NOTED OUT OF THE ORDINARY. SHE DID NOT KNOW WHAT CAUSED THE MCS TO BE DAMAGED AND DID NOT KNOW IF THERE WAS AN INSTRUMENT COLLISION. A ROBOTIC INSTRUMENT OF AN UNKNOWN TYPE WAS USED TO RETRIEVE THE FRAGMENTS. THEY DID AN X-RAY, BUT NO FRAGMENTS WERE VISIBLE. NO ADDITIONAL PROCEDURES WERE REQUIRED TO REMOVE FRAGMENTS. SHE IS NOT AWAR

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 COMPLETION OF A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, A PATIENT HAD REACHED OUT TO THE SURGEON; STATING A POST-OPERATIVE ¿BURN ON HIS UMBILICUS¿ WAS IDENTIFIED. PHOTOGRAPHS OF THE AFFECTED AREA WERE SUPPLIED TO THE SURGEON BY THE PATIENT. THE IMAGES DEPICTED A ¿PRESSURE ULCER,¿ WHICH THE SURGEON INDICATED WERE FROM A 3RD PARTY 12MM DISPOSABLE CANNULA DURING THE COURSE OF THE PROCEDURE, THE CANNULA MAY HAVE BEEN RUBBING UP AGAINST THE PATIENT POSSIBLY CAUSING THE ULCER. THE SURGEON BELIEVES THAT THE PRESSURE OF THE INDIVIDUAL AND THE CANNULA MAY HAVE CAUSED THIS. THE INITIAL DA VINCI PROCEDURE WAS COMPLETED WITH NO KNOWN OR REPORTED INJURY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON: THE SURGEON STATED THAT, ¿BELOW THE UMBILICUS IS JUST THE CLOSED PORT SITE WITH STERI-STRIPS AND DRIED BLOOD,¿ AND THAT ¿THE CRESCENT SHAPED RED AREAS¿ ABOVE THE UMBILICUS IS WHERE THE ARM PROBABLY PUSHED DOWN AND CAUSED THE PRESSURE ON A ¿DISPOSABLE 10/12 THIRD PARTY TROCAR BY ETHICON.¿ THE SURGEON SAID THAT IT APPEARS TO BE AN ABDOMINAL ¿P

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 (B)(6) 2021, INTUITIVE SURGICAL, INC (ISI) RECEIVED FDA VOLUNTARY REPORT #MW5105057 WITH THE FOLLOWING EVENT DESCRIPTION: "HAD A ROBOTIC RECTOPEXY AT (B)(6) HOSPITAL. UPON DISCHARGE ON (B)(6) 2021 I CHANGED THE DRESSING AT THE OPERATIVE SITE AND NOTICED A ¿HOLE¿ OR POSSIBLE BURNED TISSUE WHICH I REPORTED TO MY PHYSICIAN ON (B)(6) 2021, AND (B)(6) 2021. SINCE HE DID SEE THE WOUNDS POST OP. HE WAS PUZZLED AND HAS REFERRED ME TO THE WOULD CARE CLINIC. I BELIEVE THE HOSPITAL USED THE DA VINCI ROBOTIC SYSTEM AS OF 2013 OR 2014. ALTHOUGH THIS IS A RARE OCCURRENCE (MY PHYSICIAN HAS DONE OVER 400 PROCEDURES), I UNDERSTAND THAT HEAT RELATED INJURIES CAN HAPPEN WHEN SPARKS COME FROM MICROSCOPIC ¿CRACKS¿ THAT MAY / MAY NOT BE SEEN FROM THE CAMERA¿S FIELD OF VISION." THE MEDWATCH REPORT WAS LABELED WITH THE "TYPE OF EVENT" AS "SERIOUS INJURY¿ AND "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" AS "REQUIRED INTERVENTION." IN ADDITION, THE INITIAL REPORTER (A PATIENT) ELECTED TO NOT BE IDENTIFIED. THEREFORE, NO CONTACT INFORMATION WAS 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: 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: 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: (B)(6) (HEREAFTER REFERRED TO AS THE SUBJECT) IS A 76-YEAR-OLD WHITE MALE WITH BMI 27.35 AND ASA CLASSIFICATION III, NON-SMOKER WITH A MEDICAL HISTORY OF CHRONIC KIDNEY DISEASE (STAGE 3), ESSENTIAL HYPERTENSION (ON TREATMENT WITH AMLODIPINE AND CARVEDILOL), RHEUMATOID ARTHRITIS, ATRIAL FIBRILLATION, ARRYTHMIA (ON ELIQUIS, STOPPED THREE DAYS PRIOR TO THE LAR PROCEDURE), DIABETES MELLITUS, MYOCARDIAL INFARCTION (1968), SLEEP APNEA AND COMPLETE HEARING LOSS IN THE LEFT EAR. HE ALSO HAS A SURGICAL HISTORY OF RIGHT KNEE JOINT REPLACEMENT IN 2013 AND ROTATOR CUFF REPAIR IN 2018. HE HAS BEEN VACCINATED FOR COVID-19 IN (B)(6) 2021. THE SUBJECT HAD A HISTORY OF DIARRHEA OVER SEVERAL MONTHS LEADING TO HOSPITALIZATION WITH HYPOTENSION AND DEHYDRATION. HE WAS SUBSEQUENTLY DIAGNOSED WITH A RECTAL MASS ON FLEXIBLE SIGMOIDOSCOPY PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE SUBJECT MET ALL STUDY ELIGIBILITY CRITERIA AND SIGNED THE INFORMED CONSENT. ON (B)(6) 2021, THE SUBJECT UNDERWENT ROBOT-ASSISTED LOW ANTERIOR COLON RESECTION AND PRIMARY COLORECTAL ANASTOMOSIS PROCEDURE USING THE DA VINCI SP SURGICAL SYSTEM. AFTER GAINING ACCESS AND INTRODUCING THE SINGLE PORT DEVICE, A 12 MM ACCESSORY PORT WA

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 RADICAL CYSTECTOMY WITH NEOBLADDER SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF INSIDE THE PATIENT AND WAS LATER RETRIEVED FROM AN ASSISTANT PORT. THE CUSTOMER DID NOT KNOW WHAT CAUSED THE ITEM TO FALL OFF. THERE WAS NO INSTRUMENT COLLISION OR BENT TIPS. THE CUSTOMER INSPECTED THE MCS TIP COVER ACCESSORY AND NOTED IT WAS DAMAGED. 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 MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY NOTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED. THE CUSTOMER REPLACED THE INSTRUMENT TO CONTINUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. NO INSTRUMENT COLLISION WAS NOTED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF NOTICED THE MCS TIP COVER ACCESSORY WAS TORN AFT

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 THYROIDECTOMY SURGICAL PROCEDURE, WHILE CUTTING TISSUE, THE CUSTOMER FOUND THE TIP OF THE WHITE PAD OF THE HARMONIC ACE INSTRUMENT HAD FALLEN OFF OF THE INSTRUMENT AND INTO THE PATIENT. THE INSTRUMENT WAS REMOVED RIGHT AWAY. A DIFFERENT BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE, AND 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 IN USE FOR ABOUT 30 MINUTES AND BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. 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 FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED D

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE SCISSORS TIP/SLEEVE COVER FELL OFF INTRAOPERATIVELY. 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 (B)(6) 2021. THE CHARGE NURSE REPORTED THEY SHE WAS NOT PRESENT DURING THE REPORTED ISSUE; HOWEVER, WAS CALLED INTO THE ROOM AFTER THE ISSUE OCCURRED AND ASSISTED THE STAFF. THE CHARGE NURSE INFORMED THAT THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE INSTALLATION TOOL WAS USED AND NO ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE STAFF INFORMED THE CHARGE NURSE THAT DURING THE CASE, THEY HAD OBSERVED THE MCS TIP COVER ACCESSORY STARTING TO SLIDE OFF AND DECIDED TO REMOVE THE INSTRUMENT. HOWEVER, AT THE MOMENT THEY REMOVED THE INSTRUMENT THROUGH THE TROCAR, THE MCS TIP COVER ACCESSORY FELL OFF AND INTO THE PATIENT. IT WAS NOTED THE PROCEDURE HAD BEEN IN PROGRESS FOR ABOUT FIVE HOURS. IT WAS UNKNOWN IF ANY LUBRICANT WAS USED PRIOR TO THE MCS TIP COVER ACCE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF PLASTIC FROM A SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR AT THE SITE ON 09-AUG-2021 AND OBTAINED THE FOLLOWING INFORMATION: BOTH THE FRAGMENT AND THE INSTRUMENT WILL BE RETURNED TO ISI. THEY RETRIEVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. SHE ESTIMATED THE INSTRUMENT WAS IN USE FOR 2 MINUTES BEFORE IT BROKE. NO POST-OPERATIVE TESTS WERE PERFORMED AND THERE HAVE BEEN NO REPORTS OF ANY COMPLICATIONS TO THE PATIENT POST-PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT JUST FINISHED SEALING AND CUTTING TISSUE WHEN A PIECE OF PLASTIC FELL OFF THE SYNCROSEAL INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT OR WITH ANY HARD OBJECT. THE ROBOTICS COORDINATOR DID NOT WANT TO SHARE ANY PATIENT 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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A ¿SMALL RIVET¿ FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE AND THE SURGEON DISCONTINUED USING THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ON 28-JULY-2021. THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT WAS USED FOR APPROXIMATELY 10 MINUTES. THE SURGEON WAS DISSECTING BY THE HIATUS WHEN THE INSTRUMENT BROKE. THE BROKEN FRAGMENT WAS RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE RETRIEVED AND IT WAS CONFIRMED VISUALLY. NO POST-OPERATIVE TESTS WERE PERFORMED.

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: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A CUREUS JOURNAL ARTICLE TITLED, ¿USE OF BARIATRIC PORTS IN 4-ARM ROBOTIC PARTIAL NEPHRECTOMY: A COMPARATIVE STUDY WITH THE STANDARD 3-ARM TECHNIQUE¿ (EL-ASMAR, J. M., SEBAALY, R., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: "TWO PATIENTS REQUIRED POSTOPERATIVE SELECTIVE ARTERIAL EMBOLIZATION FOR POSTOPERATIVE BLEEDING/ HEMATOMA." ISI CONTACTED THE AUTHOR CORRESPONDENCE WHO CONFIRMED THAT THESE CASES WERE PERFORMED IN THEIR CENTER. THE AUTHOR CORRESPONDENCE INDICATED THAT NONE OF THE COMPLICATIONS IN QUESTION WERE DUE TO A SYSTEM MALFUNCTION AND "THESE OCCURRENCES ARE EXPECTED COMPLICATIONS AFTER PARTIAL NEPHRECTOMY AND ARE INHERENT TO THIS TYPE OF SURGERY WHATEVER THE APPROACH OPEN, LAPAROSCOPIC OR ROBOTIC."

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 WAS IN USE FOR 30 MINUTES AND A FRAGMENT FROM THE TEFLON PAD WAS FOUND TO BE MISSING. THE CUSTOMER STATED THAT THE WHITE FRAGMENTS FELL INSIDE THE PATIENT WHEN ACTIVATING THE ENERGY. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE. 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 INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR ABOUT 30 MINUTES AND BROKE WHILE IT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. THE SURGEON BELIEVED THE WHITE PART OF THE TIP MELTED WHEN ENERGY WAS ACTIVATED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE)

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, A PIECE OF THE WHITE MATERIAL, REPORTED TO BE ABOUT 0.5 MM WAS MISSING FROM INSIDE THE JAW OF THE SYNCHROSEAL. THE SURGEON REPORTEDLY DECIDED TO CONTINUE USING THE PRODUCT, AND FELT THAT SINCE THE MISSING PART WAS VERY SMALL THAT THEY WOULD NOT BE ABLE TO FIND THE MISSING PART. IT WAS UNKNOWN WHETHER THE MISSING FRAGMENT HAD FALLEN INSIDE THE PATIENT OR ELSEWHERE. 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 27-JULY-2021: IT WAS UNKNOWN IF ANY FRAGMENT FELL INSIDE THE PATIENT AND UNKNOWN IF ANY FRAGMENT WAS RETRIEVED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WAS PERFORMED TO CHECK FOR RETAINED FRAGMENTS. THE PROCEDURE HAD BEEN IN PROCESS FOR 4 HOURS AND THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR ABOUT 20 MINUTES. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS FOUND. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR. IT WAS UNKNO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROGRASP INSTRUMENT HAD A FRACTURED WIRE IN ITS CABLE SYSTEM. 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: ON (B)(6) 2021, THE SUBJECT (B)(6) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH HANDSEWN COLO-ANAL ANASTOMOSIS USING THE DA VINCI SP SURGICAL SYSTEM WITH DIVERTING LOOP ILEOSTOMY. AFTER DOCKING THE SP ROBOT, A SECONDARY PORT FOR THE STAPLING DEVICE WAS UTILIZED IN THE RIGHT LOWER QUADRANT. IT WAS NOTED THAT THE PROCEDURE WAS SUBSTANTIALLY MORE DIFFICULT BECAUSE OF SIGNIFICANT DIFFICULTY WITH MOBILIZING AND IDENTIFYING ANATOMICAL STRUCTURES DUE TO THE ALTERED SURGICAL FIELD SECONDARY TO INFLAMMATION AND TISSUE FRIABILITY LIKELY DUE TO HIS PREVIOUS HEMATOLOGICAL MALIGNANCY AND CURRENT THERAPY. THE TUMOR WAS LOCATED WITHIN A FINGER BREADTH OF THE ANAL CANAL AND DISSECTION AROUND THIS TUMOR NECESSITATED HANDSEWN COLO-ANAL ANASTOMOSIS WHICH WAS DONE WITH A STANDARD MUCOSECTOMY. THE SPECIMEN WAS DELIVERED THROUGH THE ANAL CANAL AND THEN SEWN TO THE DESCENDING COLON WITH VICRYL SUTURES. THE ANASTOMOSIS WAS EVALUATED AND FOUND TO BE VIABLE. A SINGLE DRAIN WAS LEFT IN THE DEEP PELVIS. THE TERMINAL ILEUM WAS IDENTIFIED AND BROUGHT OUT OF THE ILEOSTOMY SITE. CLOSURE OF THE SITE WAS COMPLETED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERS

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED BY AN UNSPECIFIED SURGEON, NOT THE CONSOLE SURGEON OF RECORD, THAT THERE WAS A REPORT OF A PATIENT DEATH OCCURRING ON AN SP DA VINCI SYSTEM. ADDITIONAL EVENT DETAILS (INCLUDING THE DATE OF THE EVENT), PATIENT DEMOGRAPHICS, PATIENT DATE OF DEATH, AND SYSTEM AND/OR PROCEDURE DETAILS WERE UNKNOWN AND UNATTAINABLE EVEN AFTER ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SUBJECT 600-02 (HEREAFTER REFERRED TO AS THE SUBJECT) UNDERWENT ROBOTIC-ASSISTED LOWER ANTERIOR RESECTION WITH THE DA VINCI SP SURGICAL SYSTEM ON (B)(6) 2021. ON (B)(6) 2021, THE SUBJECT MET ALL STUDY ELIGIBILITY CRITERIA AND SIGNED THE INFORMED CONSENT. THE SP SYSTEM WAS DOCKED AFTER CREATION OF THE SP PORT AND THE ILEOSTOMY PORT. ONCE THE RECTUM WAS TRANSECTED WITH THE LAPAROSCOPIC STAPLER, THE SPECIMEN WAS DELIVERED THROUGH THE WOUND PROTECTING DEVICE IN THE SP PORT. THIS WAS THEN RESECTED AND A PROLENE PURSE STRING WAS UTILIZED TO ENTER THE ANVIL INTO THE DESCENDING COLON. AFTER THIS WAS SECURED AND REPLACED BACK INTO THE ABDOMEN, THE ABDOMEN WAS REINSUFFLATED WITH THE SP ROBOTIC DEVICE AND THE ANASTOMOSIS WAS CREATED. PROCTOSCOPIC AND FINGER EXAMINATION OF THE ANASTOMOSIS REVEALED THIS TO BE INTACT. A SECTION OF THE TERMINAL ILEUM WAS IDENTIFIED NEAR THE CECUM FOR THE DIVERTING LOOP ILEOSTOMY WHICH WAS PULLED THROUGH THE ILEOSTOMY SITE. THE SP PORT WAS REMOVED, THE SITE WAS THEN CLOSED, NO DRAINS WERE PLACED. THE ILEOSTOMY WAS THEN CREATED. THE SUBJECT DID NOT EXPERIENCE ANY INTRAOPERATIVE COMPLICATIONS, AND THERE WAS NO CONVERSION TO OPEN SURGERY, ROBOTIC MULTIPORT OR LAPAROS

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 LIVER RESECTION 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. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. ON 15-JULY-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) CLARIFIED THAT THE PROMPT INDICATING EXCESS PRESSURE ON THE HARMONIC ACE INSTRUMENT DISPLAYED AFTER ONE HOUR, DURING THE PROCEDURE. THERE WAS NO ALLEGATION THAT THE INSTRUMENT CAUSED OR CONTRIBUTED TO THE BLEEDING. THE BLEEDING WAS COMING FROM THE LIVER TISSUE. THERE WAS APPROXIMATELY LESS THAN 800ML OF BLOOD LOSS. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF THE BLEEDING. THE CUSTOMER HAD TO ADMINISTER OR TRANSFUSE 400ML OF BLOOD. NO INFORMATION WAS PROVIDED REGARDING IF THE PATIENT HAD RETURNED TO THE HOSPITAL DUE TO POST

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 SURGEON FOUND THE MONOPOLAR SCISSOR TIP WAS MISSING. THE CALLER FORWARDED A PICTURE SHOWING THAT THE TIP AND THE COUPLER WERE MISSING FROM THE MONOPOLAR SCISSOR. AT THE TIME OF THE CALL THE STAFF WAS UNABLE TO LOCATE THE COUPLER. THE STAFF REPLACED THE MONOPOLAR SCISSOR TIP AND WERE PROCEEDING WITH THE PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICES ENGINEER (TSE) EXPLAINED THE COUPLER IS RADIOLUCENT. THE REPORTER EXPLAINED SHE WOULD FOLLOW UP WITH ANY FURTHER DETAILS AS SHE RECEIVED THEM. THE TSE RECOMMENDED THE STAFF RMA THE MISSING MONOPOLAR SCISSOR TIP FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION ON 01-JULY-2021: THIS WAS A MONOPOLAR SCISSOR TIP SINGLE PORT (SP) INSTRUMENT SO IT WAS THE PLASTIC PORTION THAT GOES OVER THE SCREWS AND THE ACTUAL TIP THAT FELL IN THE PATIENT. THE PIECES WAS RETRIEVED AT THE END OF THE PROCEDURE. WE HAVE REQUESTED TO SEND BACK THE INSTRUMENT AND THE BROKEN PIECES BACK TO ISI. SHE WAS NOT IN THE PROCEDURE, BUT SAID THE ROBOTICS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I HAD WHAT WAS SUPPOSED TO BE A ROUTINE GALLBLADDER REMOVAL. I SPENT THREE DAYS IN AN (B)(6) HOSPITAL, WENT HOME FOR TWO DAYS, AND SPENT AN ADDITIONAL TWO DAYS IN ANOTHER (B)(6) HOSPITAL. I EXPERIENCED BLEEDING AT A WOUND SITE (POST-SURGERY) THAT REQUIRED THREE BLOODIED DRESSING CHANGES AND SUTURING AT THE BLEEDING WOUND SITE. I WAS RELEASED FOR THE FIRST HOSPITAL, WITH A FOLEY BAG THAT WAS INSERTED ON FOUR DIFFERENT OCCASIONS, BUT NEVER SAW A UROLOGIST IN THE HOSPITAL. THE DAY AFTER DISCHARGE, I BEGAN TO BLEED, ONCE AGAIN, AT THE SUTURED WOUND SITE. I WENT TO THE LOCAL (B)(6) EMERGENCY TO HAVE THE WOUND CLEANED AND REDRESSED. TWO DAYS LATER, I CALLED A UROLOGY OFFICE NOTED IN MY DISCHARGE INSTRUCTIONS AND WAS TOLD THEY COULD NOT SEE ME FOR TWO WEEKS. I WENT BACK TO THE LOCAL (B)(6) EMERGENCY ROOM TO HAVE THE CATHETER REMOVED. THEY PERFORMED ADDITIONAL TESTS AND SAID I WAS BLEEDING INTERNALLY AND HAD POCKETS OF BLOOD IN THREE LOCATIONS IN MY ABDOMEN AND RUSHED ME TO A DIFFERENT (B)(6). A PHYSICIAN, WHO IDENTIFIED HIMSELF AS PART OF THE SURGICAL TEAM, SAID HE WANTED ME TO STAY IN THE HOSPITAL, OVERNIGHT, TO MONITOR MY HEMOGLOBIN LEVEL. I ASKED THE "SURGICAL TEAM" PHYSICIAN TO ARRANG

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 NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF THE MCS INSTRUMENT. IT WAS NOTED THAT THEY "FLIPPED BETWEEN ROBOT TO OPEN TO LAP SEVERAL TIMES" FOR THE PROCEDURE AND THAT DURING ONE OF THE TRANSITIONS THEY NOTICED THAT THE MCS TIP COVER ACCESSORY WAS MISSING. THE CUSTOMER WAS ASKING IF THE ITEM WAS DETECTABLE VIA X-RAY OR CT SCAN. THE CUSTOMER LATER FOLLOWED UP TO LET US KNOW THAT THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE, AND THAT THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP ON 21-JUNE-2021. THE CUSTOMER WAS UNABLE TO SPECIFY AT WHAT POINT THE MCS TIP COVER ACCESSORY HAD FALLEN OFF OF THE INSTRUMENT. NO FURTHER DETAILS WERE AVAILABLE.

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

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, "MOST RECENTLY WAS AN ISSUE WITH THE NEW SYNCHROSEAL INSTRUMENT, PATIENT SAFETY CONCERN WITH BROKEN PIECE." THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. CUSTOMER FEEDBACK RELATED TO AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT WAS RECEIVED VIA A BLIND SURVEY. ISI IS UNABLE TO PERFORM FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION DUE TO THE NATURE OF HOW THIS INFORMATION WAS COLLECTED. NO PRODUCT, REPORTER, OR SITE INFORMATION WAS AVAILABLE.

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