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 JOURNAL OF A BRITISH JOURNAL OF SURGERY (BJS) OPEN ARTICLE TITLED, ¿OUTCOMES OF ROBOTIC LOW ANTERIOR RESECTION VERSUS TRANSANAL TOTAL MESORECTAL EXCISION FOR RECTAL CANCER¿ (BUAN, J. L. B., SO, W. Z., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING ROBOTIC LOW ANTERIOR RESECTION (RLAR) PROCEDURES WERE NOTED. PER THE ARTICLE, THE FOLLOWING WAS NOTED: "RLAR WAS PERFORMED WITH THE DA VINCI SI VR (INTUITIVE SURGICAL, SUNNYVALE, CALIFORNIA, USA) SYSTEM IN TWO PHASES, WITH REDOCKING AS STANDARD PRACTICE AT THIS INSTITUTION," AND, "IN THE RLAR GROUP SIX PATIENTS HAD COMPLICATIONS OF GRADE III AND ABOVE, OF WHOM FOUR HAD ANASTOMOTIC LEAKS, ONE HAD A POSTOPERATIVE BILOMA FROM A SYNCHRONOUS LIVER RESECTION, AND ONE HAD NARROWING OF THE AFFERENT LIMB OF THE DE-FUNCTIONING ILEOSTOMY THAT REQUIRED SURGICAL REVISION." ISI FOLLOWED UP WITH THE AUTHOR AND OBTAINED THE FOLLOWING INFORMATION: THE AUTHOR WAS UNABLE TO PROVIDE THE NAMES OF THE SURGEONS BUT CONFIRMED THAT THE STUDY HAD (B)(6) SURGEONS INVOLVED IN THESE CASES. WITH REGARDS TO THE PATIENT WITH THE BILOMA, THE PATIENT REQUIRED A LIVER RESECTION DUE TO LIVER META

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 JOURNAL OF A BRITISH JOURNAL OF SURGERY (BJS) OPEN ARTICLE TITLED, ¿OUTCOMES OF ROBOTIC LOW ANTERIOR RESECTION VERSUS TRANSANAL TOTAL MESORECTAL EXCISION FOR RECTAL CANCER¿ (BUAN, J. L. B., SO, W. Z., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING ROBOTIC LOW ANTERIOR RESECTION (RLAR) PROCEDURES WERE NOTED. PER THE ARTICLE, THE FOLLOWING WAS NOTED: "RLAR WAS PERFORMED WITH THE DA VINCI SI VR (INTUITIVE SURGICAL, SUNNYVALE, CALIFORNIA, USA) SYSTEM IN TWO PHASES, WITH REDOCKING AS STANDARD PRACTICE AT THIS INSTITUTION," AND, "IN THE RLAR GROUP SIX PATIENTS HAD COMPLICATIONS OF GRADE III AND ABOVE, OF WHOM FOUR HAD ANASTOMOTIC LEAKS, ONE HAD A POSTOPERATIVE BILOMA FROM A SYNCHRONOUS LIVER RESECTION, AND ONE HAD NARROWING OF THE AFFERENT LIMB OF THE DE-FUNCTIONING ILEOSTOMY THAT REQUIRED SURGICAL REVISION." ONLY ONE OF THE PATIENTS WHO EXPERIENCED AN ANASTOMOTIC LEAK REQUIRED A RE-OPERATION IN WHICH THE PELVIC ABSCESS WAS DRAINED TRANSANALLY AND THE LEAK WAS MANAGED WITH THE ENDO-SPONGEVR SYSTEM. ADDITIONALLY, PER THE JOURNAL ARTICLE, THE FOLLOWING IS NOTED: "DISTAL TRANSECTION WAS PERFORMED WITH ENDOSCOPIC

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT A FEW HOURS AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXHIBITED SIGNS OF A LEAK. THE PATIENT HAD 4.5 L OF BLOOD IN HIS STOMACH THAT WAS DRAINED IN A SUBSEQUENT PROCEDURE. ON 15-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS AN AFRICAN AMERICAN MALE, WEIGHING (B)(6) LBS, WITH A MEDICAL HISTORY OF OBESITY, SLEEP APNEA, AND HYPERTENSION. IT WAS REPORTED THAT A FEW HOURS AFTER A DA VINCI ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND HE EXHIBITED SIGNS OF INTERNAL BLEEDING. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY, AND APPROXIMATELY 4.5 LITERS OF BLOOD WAS IDENTIFIED IN HIS STOMACH. THE SURGEON REMOVED THE CLOTS AND DRAINED THE BLOOD. AS A PRECAUTION, SHE PLACED CLIPS ON THE STAPLE LINES, APPLIED SURGICEL ON THE SEAL OF THE SHORT GASTRIC ARTERY, AND SEALED THE OMENTUM WITH A HARMONIC SCALPEL INSTRUMENT. THE SURGEON COULD NOT CONFIRM THE SOURCE OF THE BLEEDING; HOWEVER, SHE BELIEVES IT COULD HAVE BEEN DUE TO SPASM OF THE SHORT GASTRIC ARTERY RIGHT AFTER THE PROCEDURE, WHICH COULD H

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AN INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SERVICE (CS) REPRESENTATIVE RECEIVED AN INCOMING CALL AND IT WAS INITIALLY REPORTED THAT AN UNSPECIFIED PATIENT HAD A DA VINCI SURGERY FOR UTERUS REMOVAL AND THAT SHE HAD PHYSICAL CHANGES AFTERWARDS TO HER STOOL, HER SLEEP PATTERNS, AND HER URINARY CONTINENCE. WHEN ADDITIONAL DETAILS WERE REQUESTED, THEY WERE REFUSED BY THE INITIAL REPORTER. NO HOSPITAL, SURGEON, PROCEDURE DATE/DATE RANGE, OR PATIENT INFORMATION WAS ABLE TO BE OBTAINED. ISI HAS REACHED OUT TO THE INITIAL REPORTER 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIAL RESECTIONS WERE AROUND 4-4.5 MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY (14MM) THAN PLANNED (10MM) WITH NO KNOWN REPORTED IMPACT TO THE PATIENT. PATIENT WAS PAIN FREE AND DISCHARGED 3 DAYS POST OP. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS INCIDENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED BY A DOCTOR THAT AFTER A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A URETERAL STRICTURE OCCURRED AND WAS PROBABLY DUE TO HEAT DAMAGE. THE DOCTOR SPECULATES THAT HEAT WAS TRANSFERRED FROM THE WRIST OF THE SYNCHROSEAL INSTRUMENT TO THE URETER AND THAT THERMAL DAMAGE TO THE URETER CAUSED A STRICTURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON FROM THE SITE AND OBTAINED THE FOLLOWING INFORMATION ON (B)(6) 2021. THE SYNCHROSEAL INSTRUMENT WAS EXAMINED BEFORE USE AND THERE WERE NO ABNORMALITIES SEEN. THE SURGEON DID NOT HAVE ANY ISSUES USING THE SYNCHROSEAL INSTRUMENT AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DETECTED DURING THE PROCEDURE. THE JAWS OF THE SYNCHROSEAL INSTRUMENT WERE NOT IMMERSED IN CONDUCTIVE FLUIDS AND DID NOT COME INTO CONTACT WITH ANY NON-TARGET TISSUE OR METALLIC OBJECTS WHILE ENERGIZED. ADDITIONALLY, THE SYNCHROSEAL INSTRUMENT WAS NOT USED TO ENERGIZE THE TIPS OF OTHER INSTRUMENTS AND THE SURGEON HAD GOOD VISIBILITY OF THE JAWS AS WELL AS THE ANATOMY SURROUNDING THE INSTRUMENT DURING SYNCHROSEAL ACTIVATIONS. THERE WAS NO ARCING/BURNING SEEN. THE SURGEON CONFI

ExcelsiusGPS — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AN EXCELSIUS ROBOT WAS IN USE WHEN A PATIENT EXPERIENCED ADVERSE HEALTH EFFECTS AND PASSED AWAY.

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 JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿HELLER MYOTOMY PERFORATION: ROBOTIC VISUALIZATION DECREASES PERFORATION RATE AND REVISIONAL SURGERY IS A PERFORATION RISK¿ (ENGWALL-GILL, A. J., SOLEIMANI, T. ET AL., 2021). WITHIN THE JOURNAL ARTICLE, A POST-OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: "ONLY ONE PATIENT, WHO WAS IN THE ROBOTIC GROUP, SHOWED A LEAK ON POSTOPERATIVE ESOPHAGRAM. THIS DIRECTLY CONTRIBUTED TO HER PROLONGED POSTOPERATIVE STAY. THIS PATIENT HAD SUSTAINED A PERFORATION AT HER ORIGINAL LAPAROSCOPIC SURGERY AND THEN SUSTAINED PERFORATION AGAIN WHILE UNDERGOING REVISIONAL ROBOTIC SURGERY. IN THIS PARTICULAR CASE, THERE WAS MINIMAL LEAK OF CONTRAST INTO A CONTAINED PERFORATION, WHICH RESPONDED TO SUPPORTIVE MEASURES, ANTIBIOTICS, AND NUTRITION. SHE WAS HOSPITALIZED FOR A TOTAL OF 11 DAYS DUE TO AN EARLY POSTOPERATIVE COMPLICATION OF PNEUMONIA." ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TKA SURGERY AND THE CUTS PERFORMED ON THE TIBIA WERE 4MM OFF (OVERCUT) FROM PLANNED RESECTION VALUES. THE PROCEDURE WAS COMPLETED USING A LARGER POLY INSERT (16 MM) WITH NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 02-SEP-2021, INTUITIVE SURGICAL (ISI) BECAME AWARE OF AN UPDATES IN SURGERY ARTICLE TITLED, ¿FEASIBILITY AND SAFETY OF ROBOTIC-ASSISTED TOTAL PANCREATECTOMY (RATP): THIS STUDY INCLUDES PATIENTS OPERATED BETWEEN OCTOBER 2008 AND DECEMBER 2019: A PILOT WESTERN SERIES¿ (KAUFFMANN, E. F., NAPOLI, N., ET AL., 2021). WITHIN THE ARTICLE, THE FOLLOWING WAS NOTED: "REGARDING THE MAIN ENDPOINT OF THIS STUDY, AS SHOWN IN TABLE 3, SEVERE POST-OPERATIVE COMPLICATIONS DEVELOPED IN 6 PATIENTS (24.0%) AFTER RATP AND IN 13 PATIENTS (26.0%) AFTER OTP (P=0.85)." ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

da Vinci Surgical System — Death 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 AN 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 PSEU

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)(4) UNDERWENT ROBOT-ASSISTED ULTRA-LOW ANTERIOR RESECTION WITH PERIAORTIC LYMPH NODE DISSECTION, TOTAL MESORECTAL EXCISION, PRIMARY LOW PELVIC COLOANAL ANASTOMOSIS USING THE DA VINCI SP SURGICAL SYSTEM AND LAPAROSCOPIC DIVERTING LOOP ILEOSTOMY. ON (B)(6) 2021, THE SUBJECT MET ALL STUDY ELIGIBILITY CRITERIA AND SIGNED THE INFORMED CONSENT. THE SUBJECT HAD VERY DIFFICULT ANATOMY IN PART DUE TO THE PREVIOUS STAGED PROCEDURE AND THE LOCATION OF THE LESION IN THE LOW RECTUM. AFTER OBTAINING SINGLE PORT ACCESS, THE PORT WAS PLACED, ROBOT WAS DOCKED, AND AN ADDITIONAL 12 MM PORT WAS PLACED IN THE RIGHT QUADRANT. PERIOAORTIC LYMPH NODE DISSECTION WAS PERFORMED. THE SPECIMEN WAS EXTRACORPOREALIZED BY UNDOCKING THE DA VINCI SP SYSTEM USING THE WOUND RETRACTOR PLACED AT THE UMBILICUS. THE ANVIL WAS THEN SECURED TO THE CIRCULAR LAP STAPLER (SIZE 29) WITH A PURSE STRING SUTURE. THE DA VINCI SP SYSTEM WAS THEN RE-DOCKED, PNEUMOPERITONEUM WAS REESTABLISHED AND A LOW PELVIC COLOANAL ANASTOMOSIS WAS CREATED WHICH WAS INTACT AND TENSION-FREE. THE DOUGHNUTS WERE CHECKED AND WERE INTACT. THE AIR INSUFFLATION TEST ALSO REVEALED NO BUBBLES OR LEAKS. AT THIS JUNCTURE, THE 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: A ROBOTIC FORCE BIPOLAR INSTRUMENT WAS USED DURING THE CASE. "A SPRING?" BROKE DURING THE CASE. AT FIRST IT WAS UNKNOWN IF ANY FRAGMENTS FELL OFF INTO THE PATIENT. AN X-RAY WAS ORDERED AND TAKEN. NO DENSITIES WERE SEEN ON THE X-RAY. A NEW INSTRUMENT WAS OPENED AND THE CASE WAS COMPLETED. THIS INSTRUMENT WILL BE SENT BACK TO INTUITIVE FOR EVALUATION AND REIMBURSEMENT; 3/12 LIVES REMAIN ON INSTRUMENT. THERE ARE NO APPARENT MISSING SCREWS NOR BROKEN CABLES UPON VISUAL INSPECTION, HOWEVER THE JAWS OF THE INSTRUMENT AREN'T ABLE TO BE OPENED ALL THE WAY. 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 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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT NOTIFIED THE PULMONOLOGY TEAM AT THE HOSPITAL TO PICK UP THE OXYGEN EQUIPMENT AS THE PATIENT DISCONTINUED OXYGEN THERAPY AND ASKED THAT THE EQUIPMENT BE PICKED 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: 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.

Electric vacuum cleaner (self-propelled/robot type), model SY-111 — A self-propelled (robot) vacuum cleaner caught fire while connected to its charging stand at a residence in Chiba Prefecture, burning the unit and the surrounding area. NITE's investigation found a lithium-ion battery cell had likely overheated and ignited, but due to the severity of the burn damage it could not conclusively determine whether the product itself was the cause. No injuries were 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 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

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY THE PATIENT EXPERIENCED APPROXIMATELY 1-2MM OF FEMORAL NOTCHING. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY THERE WAS A DISCREPANCY BETWEEN THE PLANNED AND VALIDATED RIGHT FEMORAL CUTS. THE PROCEDURE WAS DELAYED APPROXIMATELY 25 MINUTES. NO ADDITIONAL PATIENT IMPACT 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 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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A SCREW WAS MISPLACED AT LS1 AND RIGHT S1, RESULTING IN A DURAL TEAR, WHICH WAS REPAIRED INTRA-OPERATIVELY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS RIGHT MIDDLE LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED ON 8/11/21 AND THE PATIENT WAS DISCHARGED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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