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: CONCERNING THE 3 BIOPSIES PERFORMED, THE PROCEDURE DID NOT POSE ANY PARTICULAR PROBLEM, THE FIXATION WAS WITH A MAYFIELD HEAD HOLDER IN CLASSIC DECUBITUS, THERE WAS NO HEMORRHAGIC COMPLICATION OBJECTIFIED AT THE POSTOPERATIVE CONTROL CT SCAN. ON THE OTHER HAND, THE ANALYSIS OF THE SAMPLES WAS NEGATIVE, REQUIRING A SECOND SURGICAL INTERVENTION TO OBTAIN THE DIAGNOSIS, AND THEREFORE A DELAY IN ONCOLOGICAL MANAGEMENT OF ABOUT ONE MONTH.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT EXPERIENCED BLEEDING DURING THE BRONCHOALVEOLAR LAVAGE (BAL). THE RIGHT UPPER LOBE (RUL) WAS VISUALIZED AND BLEEDING WAS IDENTIFIED AND ORIGINATED FROM THE POSTERIOR SEGMENT. A DROP IN SATURATIONS REQUIRED MANUAL BAGGING FOR VENTILATION. THE BLEEDING WAS SUCCESSFULLY TREATED WITH EPINEPHRINE AND BALLOON TAMPONADE. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO SUBSEQUENT COMPLICATION. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM (OR) AND WAS ADMITTED FOR FURTHER OBSERVATION AND WAS RELEASED THE FOLLOWING DAY.

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 THYROID RESECTION SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSERT BROKE OFF AND FELL INSIDE THE PATIENT DURING FIRING. THE FRAGMENT WAS RETRIEVED THROUGH AN ASSISTANT PORT DURING THE SAME PROCEDURE. THE CUSTOMER USED AN ENDOSCOPE AND 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 HARMONIC ACE INSERT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. THE HARMONIC ACE INSERT WAS IN USE FOR APPROXIMATELY 30 MINUTES AND PERFORMED AS INTENDED UP UNTIL THE REPORTED EVENT. THE HARMONIC ACE INSERT WAS REMOVED PRIOR TO AND AFTER THE BREAKAGE WITH NO RESISTANCE THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE HARMONIC ACE INSERT OR CANNULA AFTER THE EVENT OCCURRED. 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) 2021, INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CUSTOMER USED A

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED HIATAL-HERNIA PERIESOPHAGEAL SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT DID NOT WORK TO STOP THE BLEEDING. IT IS UNCLEAR WHAT SURGICAL TASK THE SURGEON WAS ATTEMPTING TO PERFORM WHEN THE REPORTED EVENT OCCURRED. THE SURGEON HAD TO SWITCH TO A VESSEL SEALER EXTEND INSTRUMENT TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI EXECUTIVE SALES REPRESENTATIVE (ESR) WHO WAS PRESENT FOR THE PROCEDURE AND OBTAINED ADDITIONAL INFORMATION ON 16-NOV-2021. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SYNCHROSEAL INSTRUMENT WAS NOT SEALING THE SHORT GASTRIC VESSELS ALONG THE GREATER CURVATURE OF THE STOMACH IN THE SYNCH AND SEAL MODES. THE CUTTING FUNCTION WAS WORKING IN THE SYNCH MODE BUT NOT THE SEALING FUNCTION ALTHOUGH THE GENERATOR GAVE THE APPROPRIATE TONES. AS A RESULT, THE VESSELS WERE OOZING/ BLEEDING. THE ESTIMATED BLOOD LOSS WAS LESS THAN 750 ML. THE SURGEON THEN USED A VESSEL SEALER EXTEND INSTRUMENT TO OBTAIN CONTROL AND STOP THE BLEEDING FROM THE SHORT GASTRIC VESSELS. THERE WERE NO ERRORS THAT OCCURRED AT THE TIME OF THE INC

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ACCURATE PEDICLE SCREW PLACEMENT IS CRITICAL TO SURGICALLY CORRECT PEDIATRIC HIGH-GRADE SPONDYLOLISTHESIS (HGS). THE RECENT ADVENT OF ROBOTICS COUPLED WITH COMPUTER-ASSISTED NAVIGATION (RAN) MAY REPRESENT A NOVEL OPTION TO IMPROVE SURGICAL OUTCOMES OF HGS, SECONDARY TO ENHANCED PEDICLE SCREW PLACEMENT SAFETY. THIS SERIES PRESENTS THE HGS-RAN TECHNIQUE ADOPTED BY OUR SITE, DESCRIBING ITS SURGICAL OUTCOMES AND FEASIBILITY. CONSECUTIVE PATIENTS WITH A DIAGNOSIS OF HGS (MEYERDING GRADE III TO V), OPERATED ON USING RAN FROM 2019 TO 2020 AT A SINGLE-CENTER WERE REVIEWED. DEMOGRAPHICS, SCREW ACCURACY, SAGITTAL L5-S1 PARAMETERS, COMPLICATIONS, AND PERIOPERATIVE OUTCOMES WERE DESCRIBED. ALL PATIENTS WERE TREATED WITH INSTRUMENTATION, DECOMPRESSION, POSTERIOR LUMBAR INTERBODY FUSION, AND REDUCTION. ROBOTIC TIME INCLUDED ANATOMIC REGISTRATION TO END OF SCREW PLACEMENT. SCREW ACCURACY, DEFINED AS A SCREW PLACED SAFELY WITHIN THE PLANNED INTRAPEDICULAR TRAJECTORY WAS CHARACTERIZED BY THE GERTZBEIN-ROBBINS SYSTEM FOR PATIENTS WITH ADDITIONAL 3-DIMENSIONAL IMAGING. TEN HGS PATIENTS, WITH AN AVERAGE AGE OF 13.7 YEARS OLD, WERE INCLUDED IN THE SERIES. ALL 62 SCREWS WERE PLACED WITHOUT NEU

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 TKA SURGERY WITH ROBOTIC INSTRUMENTATION THE SURGEON PLANNED FOR TIBIA 0 DEGREE V/V CUT BUT ENDED UP IN 7 DEGREE VARUS (FROM POST-OP X-RAY). THE ROBOTIC SYSTEM SUGGESTED TIBIA BONE CUT OF 11.5MM ON LATERAL AND 9MM ON MEDIAL. THE VERIFIED CUT WAS 9MM MEDIAL AND 12MM LATERAL. VERIFICATION SHOWED 1 DEGREE OF VALGUS. FROM PRE-OP X-RAY TEMPLATING, SURGEON SHOULD HAVE CUT 12MM ON LATERAL AND 4MM ON MEDIAL TO GET THE KNEE STRAIGHT. NO MID SURGERY INTERVENTION OCCURRED. SURGEON EXECUTED THE SURGERY THAT WAS ORIGINALLY PLANNED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS 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 ESOPHAGECTOMY TRANSTHORACIC CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE METAL TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF. THE FRAGMENT WAS RETRIEVED DURING THE PROCEDURE. THE CUSTOMER WAS TAKING OUT TISSUE WHEN THE INSTRUMENT BROKE. THE INSTRUMENT WRIST STRAIGHTENED UPON REMOVAL. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A SMALL PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED DURING POST-OP CHECK VIA A CHEST X-RAY. THE LOCATION OF THE PNEUMOTHORAX WAS LEFT UPPER LOBE (LUL). THE PNEUMOTHORAX WAS TREATED EXPECTANTLY WITH OXYGEN AND HOSPITALIZATION ON (B)(6) 2021. A SECOND CHEST X-RAY WAS TAKEN, AND PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ZIMMER BIOMET MEDTECH HAS BEEN MADE AWARE OF A SERIOUS ADVERSE EVENT THAT OCCURRED AT THE HOUSTON VA, IN WITH ROBOT S/N (B)(6). A SYSTEMATIC REGISTRATION ERROR APPEARED TO BE PRESENT WITH AN INTRAOPERATIVE O-ARM SPIN. THE DAY OF THESE CASE, WEDNESDAY (B)(6), AN INACCURACY OCCURRED. ON THE FOLLOWING DAY, THE (B)(6), THE PATIENT HAD AN INTRAPARENCHYMAL HEMATOMA OF ABOUT 2 CM IN SIZE. THE PATIENT IS ANTICIPATED TO MAKE A FULL RECOVERY.

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, TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT IN THE SAME PROCEDURE. THE FRAGMENT AND THE INSTRUMENT WILL BE RETURNED FOR EVALUATION. THEY WERE DISSECTING WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THERE WAS NO TIP OR INSTRUMENT COLLISION. THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ORIGINAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ON 15-NOV-2021. THE INSTRUMENT WAS INSPECTED IN THE NORMAL PRE-OPERATION INSPECTION AND NOTHING OUT OF THE ORDINARY WAS NOTED. THE INSTRUMENT WAS USED FOR APPROXIMATELY 1.5 HOURS. THE FRAGMENT WAS RETRIEVED BY THE BEDSIDE ASSIST USING A LAPARSCOPIC INSTRUMENT. BOTH THE INSTRUMENT AND THE FRAGMENT WERE GIVEN TO THE MATERIALS DEPARTMENT TO COMPLETE THE RETURN. NO INJURY WAS OBSERVED TO THE PATIENT AT THE TIME OF THE ISSUE. HE WAS NOT AWARE IF ANY POST-OPERATIVE TESTS WERE PERFORMED TO VERIFY ALL FRAGMENTS WERE RETRIEVED AND HE WAS NOT AWARE IF THE PATIENT HAD EXPERIENCED ANY POST-SURGICAL COM

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WAS LEFT UPPER LOBE. IN ADDITION TO THE PNEUMOTHORAX, THE PATIENT SUFFERED AN ALLERGIC REACTION TO ANESTHETIC. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED ON (B)(6) 2021.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MPS REPORTED ROBOT ISSUES. MPS REPORTED REAMING THROUGH MEDIAL WALL AND OTHER ISSUES. AS REPORTED VIA COMPLAINT FORM: AFTER IMPACTION, 48 CUP WOULD NOT STICK. SURGEON INDICATED THAT POSTERIOR WALL MAY HAVE BEEN REAMED THROUGH. SURGICAL DELAY = 15 MINUTES. CASE COMPLETED MANUALLY. CASE TYPE / APPLICATION: THA 4.0. UPDATE: ADDITIONAL INFORMATION RECEIVED FROM MPS: "THE SURGEON INDICATED THAT SHE DID NOT NOTICE THE POSTERIOR MEDIAL WALL HAVING DAMAGE UNTIL AFTER CUP IMPACTION. ANOTHER SURGEON WHO HELPED HER WITH THE REPAIR/AUGMENT STATED THAT HE BELIEVED IT MAY HAVE BEEN CAUSED DURING CUP IMPACTION IN COMBINATION WITH A THIN MEDIAL WALL AS OPPOSED TO THE REAMING PORTION."

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) AND LOW ANASTOMOSIS ON (B)(6) 2021, THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY (POD) #2, THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION ON POD #13. THE UMBILICAL INCISION HAD ECCHYMOSIS CONSISTENT WITH PRESSURE FROM THE ROBOT AND SOME SEROUS DRAINAGE WAS OBSERVED. THE INCISION WAS OPENED, AND THE SEROSANGUINOUS DRAINAGE WAS EXPELLED. THE WOUND WAS THEN PACKED WITH ½-INCH IODOFORM, COVERED WITH 4X4 GAUZE. THE INFECTION WAS RESOLVED BY POD #43.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT A SINGLE LEVEL MIS TLIF AT L4-L5 PROCEDURE WAS PLANNED. AFTER THE RIGHT L5 GUIDEWIRE WAS INSERTED, THE SURGEON REALIZED THERE WAS SOMETHING WRONG WHEN INSERTING THE RIGHT L4 GUIDEWIRE. IMAGING WAS DONE WITH THE C-ARM AND THE SURGEON FOUND THEY WERE NOT IN THE PLANNED TRAJECTORIES. THE SCREWS INTENDED FOR L5 WERE AT L4 AND THE SURGICAL ARM WAS SENT TO THE WRONG LEVEL. TROUBLESHOOTING INVOLVED CHECKING THE PLAN AND LABELING AND RESENDING THE SURGICAL ARM TO THE TRAJECTORY. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM AND COMPLETE THE PROCEDURE FREEHAND USING THE C-ARM. THE PATIENT'S L3 EXITING NERVE ROOT WAS DAMAGED, BUT THE PATIENT'S MOTOR FUNCTION WAS NOT IMPACTED. THE PATIENT WAS STILL UNDER OBSERVATION. THE PROCEDURE WAS DELAYED TWO HOURS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPOSITION A MISPLACED L5 RIGHT SCREW.

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 THE SITE¿S ROBOTIC COORDINATOR TO INTUITIVE SURGICAL INC, (ISI) CUSTOMER SERVICE, THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, THE SYNCHROSEAL INSTRUMENT ALLEGEDLY MISFIRED AND DID NOT ADEQUATELY SEAL A VESSEL. AS A RESULT, BLEEDING WAS OBSERVED. ON 02-NOV-2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM A SITE ROBOTICS NURSE, STEMMING FROM INFORMATION PROVIDED BY OPERATING ROOM (OR) STAFF WHO WERE PRESENT FOR THE CASE: THE SYNCHROSEAL INSTRUMENT DID NOT ACTIVATE AT ONE TIME DURING THE SURGICAL PROCEDURE BUT THE PHYSICIAN CONTINUED TO USE THE DEVICE. A SECOND BACKUP INSTRUMENT WAS NOT OPENED AND USED DURING THE CASE. THE ROBOTICS NURSE IS UNSURE OF THE AMOUNT OF BLOOD LOSS AND CONFIRMED THAT THE INSTRUMENT WAS RETURNED FOR EVALUATION. NO OTHER ADDITIONAL 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: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY PROCEDURE, DURING "VASCULARIZATION" OF THE HILAR REGION OF THE LUNG, THE PATIENT EXPERIENCED BLEEDING. THE CAUSE OF THE BLEEDING WAS NOT DISCLOSED. THE SURGEON COULD NOT CONTROL THE BLEEDING; MEDIUM-LARGE CLIPS WERE USED TO IN AN ATTEMPT TO CONTROL THE BLEED WITHOUT SUCCESS. AS A RESULT, THE SURGEON DECIDED TO CONVERT TO OPEN CHEST SURGERY. ON 25-OCT-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED RIGHT PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING DURING HILAR VASCULAR TREATMENT WITH THE SYNCHROSEAL INSTRUMENT. THE SURGEON INDICATED THAT THE CAUSE OF THE BLEED MIGHT HAVE BEEN RELATED TO "TENSION" OR DAMAGE TO AN UNSPECIFIED VESSEL WHEN "PEELING" AND "NOT CUTTING" WITH THE SYNCHROSEAL INSTRUMENT. IT IS UNCLEAR WHAT THE SURGEON MEANT BY "PEELING." THE SURGEON TRIED TO STOP THE BLEEDING WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT AND SUCTIONING. THE SURGEON APPLIED JUST ONE CLIP BUT WAS UNABLE TO PLACE A SECOND CLIP FOR AN UNKNOWN REASON. THE SURGEON COULD NOT CONTROL THE BLEEDING. DUE TO THE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REMOVE A MISPLACED LEFT SIDE SCREW FROM THE INITIAL OPERATION. THIS EVENT OCCURRED IN (B)(6).

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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: PEDICLE SCREW INSERTION FOR STABILIZATION AFTER LUMBAR FUSION SURGERY IS COMMONLY PERFORMED BY SPINE SURGEONS. WITH THE ADVENT OF NAVIGATION TECHNOLOGY, THE ACCURACY OF PEDICLE SCREW INSERTION HAS INCREASED. ROBOTIC GUIDANCE HAS REVOLUTIONIZED THE PLACEMENT OF PEDICLE SCREWS WITH 2 DISTINCT RADIOGRAPHIC REGISTRATION METHODS, THE SCAN AND PLAN METHOD AND CT-TO-FLUOROSCOPY METHOD. IN THIS STUDY, THE AUTHORS AIMED TO COMPARE THE ACCURACY AND SAFETY OF THESE METHODS. A RETROSPECTIVE CHART REVIEW WAS CONDUCTED AT 2 CENTERS TO OBTAIN OPERATIVE DATA FOR CONSECUTIVE PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR PEDICLE SCREW PLACEMENT. THE NEWEST ROBOTIC PLATFORM (MAZOR X ROBOTIC SYSTEM) WAS USED IN ALL CASES. ONE CENTER USED THE SCAN-AND-PLAN REGISTRATION METHOD, AND THE OTHER USED CT-TO-FLUOROSCOPY FOR REGISTRATION. SCREW ACCURACY WAS DETERMINED BY APPLYING THE GERTZBEIN-ROBBINS SCALE. FLUOROSCOPIC EXPOSURE TIMES WERE COLLECTED FROM RADIOLOGY REPORTS. OVERALL, 268 PATIENTS UNDERWENT PEDICLE SCREW INSERTION, 126 PATIENTS WITH SCAN-AND-PLAN REGISTRATION AND 142 WITH CT-TO-FLUOROSCOPY REGISTRATION. IN THE SCAN-AND-PLAN COHORT, 450 SCREWS WERE INSERTED ACROSS 266 SPINAL LEVELS (MEAN

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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: PEDICLE SCREW INSERTION FOR STABILIZATION AFTER LUMBAR FUSION SURGERY IS COMMONLY PERFORMED BY SPINE SURGEONS. WITH THE ADVENT OF NAVIGATION TECHNOLOGY, THE ACCURACY OF PEDICLE SCREW INSERTION HAS INCREASED. ROBOTIC GUIDANCE HAS REVOLUTIONIZED THE PLACEMENT OF PEDICLE SCREWS WITH 2 DISTINCT RADIOGRAPHIC REGISTRATION METHODS, THE SCAN AND PLAN METHOD AND CT-TO-FLUOROSCOPY METHOD. IN THIS STUDY, THE AUTHORS AIMED TO COMPARE THE ACCURACY AND SAFETY OF THESE METHODS. A RETROSPECTIVE CHART REVIEW WAS CONDUCTED AT 2 CENTERS TO OBTAIN OPERATIVE DATA FOR CONSECUTIVE PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR PEDICLE SCREW PLACEMENT. THE NEWEST ROBOTIC PLATFORM (MAZOR X ROBOTIC SYSTEM) WAS USED IN ALL CASES. ONE CENTER USED THE SCAN-AND-PLAN REGISTRATION METHOD, AND THE OTHER USED CT-TO-FLUOROSCOPY FOR REGISTRATION. SCREW ACCURACY WAS DETERMINED BY APPLYING THE GERTZBEIN-ROBBINS SCALE. FLUOROSCOPIC EXPOSURE TIMES WERE COLLECTED FROM RADIOLOGY REPORTS. OVERALL, 268 PATIENTS UNDERWENT PEDICLE SCREW INSERTION, 126 PATIENTS WITH SCAN-AND-PLAN REGISTRATION AND 142 WITH CT-TO-FLUOROSCOPY REGISTRATION. IN THE SCAN-AND-PLAN COHORT, 450 SCREWS WERE INSERTED ACROSS 266 SPINAL LEVELS (MEAN

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: PEDICLE SCREW INSERTION FOR STABILIZATION AFTER LUMBAR FUSION SURGERY IS COMMONLY PERFORMED BY SPINE SURGEONS. WITH THE ADVENT OF NAVIGATION TECHNOLOGY, THE ACCURACY OF PEDICLE SCREW INSERTION HAS INCREASED. ROBOTIC GUIDANCE HAS REVOLUTIONIZED THE PLACEMENT OF PEDICLE SCREWS WITH 2 DISTINCT RADIOGRAPHIC REGISTRATION METHODS, THE SCAN-AND-PLAN METHOD AND CT-TO-FLUOROSCOPY METHOD. IN THIS STUDY, THE AUTHORS AIMED TO COMPARE THE ACCURACY AND SAFETY OF THESE METHODS. A RETROSPECTIVE CHART REVIEW WAS CONDUCTED AT 2 CENTERS TO OBTAIN OPERATIVE DATA FOR CONSECUTIVE PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR PEDICLE SCREW PLACEMENT. THE NEWEST ROBOTIC PLATFORM (MAZOR X ROBOTIC SYSTEM) WAS USED IN ALL CASES. ONE CENTER USED THE SCAN-AND-PLAN REGISTRATION METHOD, AND THE OTHER USED CT-TO-FLUOROSCOPY FOR REGISTRATION. SCREW ACCURACY WAS DETERMINED BY APPLYING THE GERTZBEIN-ROBBINS SCALE. FLUOROSCOPIC EXPOSURE TIMES WERE COLLECTED FROM RADIOLOGY REPORTS. OVERALL, 268 PATIENTS UNDERWENT PEDICLE SCREW INSERTION, 126 PATIENTS WITH SCAN-AND-PLAN REGISTRATION AND 142 WITH CT-TO-FLUOROSCOPY REGISTRATION. IN THE SCAN-AND-PLAN COHORT, 450 SCREWS WERE INSERTED ACROSS 266 SPINAL LEVELS (MEAN

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

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BILATERAL MAKO THA PROCEDURE (DA APPROACH), RIGHT SIDE COMPLETED FIRST WITHOUT ISSUE. SWITCHED OFF AND MOVED ROBOT TO LEFT SIDE SIDE TO PREP FOR LEFT SIDE OF BILATERAL HIP, REBOOTED AND FOUND BOTH MAKO MONITORS DISPLAYING A SCREEN WITH BLINKING SQUARE PROGRESS BAR (I RECORDED VIDEO OF IT TO UPLOAD). THIS SCREEN COULD NOT BE ALTERED WITH SOFT REBOOT. COMPLETED HARD REBOOT AND SAME SCREEN REAPPEARED. WAITED SEVERAL MINUTES BEFORE LOGIN SCREEN APPEARED AND PROCEEDED TO RE-HOME ROBOT. I DIDN¿T THINK MUCH OF THIS STARTUP ISSUE UNTIL AN ISSUE DEVELOPED WHEN SURGEON BEGAN REAMING ACETABULUM. SURGEON REAMED MEDIAL TO PLAN WITH THE MAKO CAUSING A PROTRUSIO. EVERYTHING CHECKED OUT OKAY (REGISTRATION PASSED FINE, BOTH CHECKPOINTS PASSED, OFFSET REAMER ORIENTATION 90-DEG MATCHING ROBOT, REAMER SIZE BASKET ETC). PREPLAN WAS MEDIALISED FROM NATIVE CENTRE OF ROTATION BUT OBVIOUSLY NOT THROUGH MEDIAL WALL. SURGEON FIXED SITUATION WITH BONE GRAFT IMPACTION TO PLUG IT USING REVERSE REAM AND WE USED MAKO TO IMPACT CUP (PROUD 6MM WHICH CLINICALLY WAS SEATED WELL AND WOULD SUGGEST THE MEASUREMENT OF CUP IMPACTION TO PLAN BASED OFF THE DEEPEST OVER-REAM WAS ACCURATE. FINAL REDUCTION NUMBERS WERE CLINICA

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: MULTIPLE-ROD CONSTRUCTS (MRCS) ARE OFTEN USED IN DEFORMITY CORRECTION FOR INCREASED STABILITY AND RIGIDITY. THERE ARE CURRENTLY NO REPORTS SHOWING MINIMALLY INVASIVE PLACEMENT OF MRCS IN ADULT DEFORMITY SURGERY AND ITS TECHNICAL FEASIBILITY THROUGH PREOPERATIVE SOFTWARE PLANNING. DATA WERE COLLECTED RETROSPECTIVELY FROM MEDICAL RECORDS OF SIX CONSECUTIVE PATIENTS WHO UNDERWENT MINIMALLY INVASIVE MRCS WITH ROBOTICS PLANNING BY A SINGLE SURGEON AT AN ACADEMIC CENTER BETWEEN MARCH¿AUGUST 2020. A TOTAL OF SIX PATIENTS (4 FEMALES, MEAN AGE 69.7 YEARS) UNDERWENT MINIMALLY INVASIVE LONG-SEGMENT (6 +) POSTERIOR FIXATION WITH MULTIPLE RODS (3 +) USING THE MAZOR X STEALTH EDITION ROBOTICS PLATFORM. AVERAGE FOLLOW-UP WAS 14.3 MONTHS. ALL PATIENTS UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AS A FIRST STAGE, FOLLOWED BY SECOND STAGE POSTERIOR FIXATION IN THE SAME DAY. THE MEAN NUMBER OF LEVELS POSTERIORLY INSTRUMENTED WAS 8.8. ONE PATIENT UNDERWENT 3 ROD FIXATION (1 ILIAC, 2 S2AI) AND 5 PATIENTS UNDERWENT QUAD ROD FIXATION (2 ILIAC, 2 S2AI). THE MEAN TIME TO SECURE ALL RODS WAS 8 MIN 36 S. MEAN IMPROVEMENT IN SPINOPELVIC PARAMETERS WAS -4.9 CM SAGITTAL VERTICAL AXIS, 18.0° LUM B

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