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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 DURING THE PROCEDURE PATIENT EXPERIENCE ABDOMINAL DISTENTION AND RESPIRATORY DISTRESS AND WAS HOSPITALIZE AND DRAIN PLACEMENT WAS PERFORM.

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 PANCREATODUODENECTOMY SURGICAL PROCEDURE, ONE BRANCH BROKE ON THE HARMONIC ACE INSTRUMENT. THE FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY. THIS EVENT OCCURRED IN IRELAND.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE SHEATH BROKE, PREVENTING THE DEVICE USE DUE TO AN UNRECOVERABLE ERROR ON THE SYSTEM. DURING THE USE OF THE FIRST HARMONIC ACE INSTRUMENT, THE BURN AND BREAK OF ONE OF THE BRANCHES OF THE INSTRUMENT RESULTED IN A FRAGMENT FALLING INTO THE PATIENT'S ABDOMEN. THE FRAGMENT WAS PROMPTLY RETRIEVED THE CUSTOMER USED A SECOND HARMONIC ACE INSTRUMENT, AND THE COVER SHEATH BROKE, AGAIN PREVENTING THE DEVICE FROM USE AND AN UNRECOVERABLE ERROR ON THE SYSTEM WAS DISPLAYED. THERE IS NO FURTHER INFORMATION AVAILABLE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY TO EVALUATE THE METHODOLOGIES AND SURGICAL OUTCOMES OF ROBOTIC SINGLE-SITE PLUS ONE-PORT MYOMECTOMY (RSOM) WITH ROBOTIC SINGLE-SITE PLUS ONE-PORT MYOMECTOMY (RSOM). 230 PATIENTS WHO HAD UNDERGONE RSOM AND 146 PATIENTS WHO HAD UNDERGONE RSTM BETWEEN SEPTEMBER 2020 AND SEPTEMBER 2021 AT A SINGLE INSTITUTION WERE REVIEWED, ALL WERE USING DA VINCI-X OR XI ROBOTIC SYSTEM. IN THE RSTM GROUP, THE POSTOPERATIVE COMPLICATIONS INCLUDED ONE CASE OF WOUND DEHISCENCE THAT THE LEFT SIDE TROCAR INCISION WAS REOPENED, AND RE-SUTURING WAS PERFORMED.; IN THE RSOM GROUP, THERE WAS ONE CASE OF REOPERATION REQUIRED REOPERATION ON POSTOPERATIVE DAY 1. IT WAS PROVIDED THAT AN EMERGENT LAPAROSCOPIC REOPERATION WAS PERFORMED DUE TO HEMOPERITONEUM RESULTING FROM BLEEDING AT THE UMBILICAL INCISION SITE. SUCTION AND IRRIGATION, HEMOSTASIS OF INCISION SITE, AND TRANSFUSION WERE PERFORMED, AND THE PATIENT RECOVERED WELL. ANOTHER PATIENT IN THE RSOM EXPERIENCED AN APPROXIMATELY 4-CM UMBILICAL HERNIA 4 MONTHS POST PROCEDURE, AND HERNIORRHAPHY WAS PERFORMED WITHOUT ANY COMPLICATION. NO CASE OF CONVERSION TO LAPAROTOMY OR ADDITIONAL TROCAR INSERTION WAS FOUND 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE PORT EXTRAPERITONEAL RADICAL PROSTATECTOMY PROCEDURE, A PATIENT DEVELOPED A SUBCUTANEOUS EMPHYSEMA. THE SURGEON USED AN AIRSEAL AT A PRESSURE OF 10, AND HE INCREASED THE PRESSURE TO 14 AT TIMES DURING THE PROCEDURE. THE PATIENT REPORTEDLY FELT FINE; HOWEVER, THEY WERE KEPT ONE NIGHT IN THE CRITICAL CARE UNIT (CCU). INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED.

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. IT WAS REPORTED THAT THE PATIENT HAD POST-PROCEDURE ACUTE BLOOD LOSS, ANEMIA, AND THEIR HEMOGLOBIN WAS REPORTED AS 9.0 MILLIGRAMS (MG) PER DECILITER. THE ESTIMATED BLOOD LOSS (EBL) WAS REPORTED AS 1,000 MILLILITERS (ML). DIAGNOSTIC TESTS WERE PERFORMED AND THE ADVERSE EVENT RESULTED IN TREATMENT AND A NEUROLOGICAL EXAM WAS COMPLETED. THE PATIENT RECEIVED 2 UNITS OF TRANSFUSED PACKED RED BLOOD CELLS AND RECOVERED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED INDICATED THE SURGERY BEING PERFORMED WAS FOR SPINAL DEGENERATIVE DISEASE AND THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2024.

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 PROCEDURE, THE CUSTOMER OBSERVED THAT THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN OFF. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. THE USER CONTINUED AND COMPLETED THE PROCEDURE ROBOTICALLY WITHOUT FURTHER ISSUES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EGPS SYSTEM IS NOT WORKING PROPERLY SINCE IT WAS SERVICED ON WEDNESDAY OF THIS WEEK. WE NEED THIS FIXED ASAP. THE ROBOT SEEMED "SLOW". THE SURGEON WOULD STOP ADVANCING THE SCREW BUT THERE WAS A HALF SECOND DELAY ON THE SCREEN. I AM NOT SURE IF IT IS E3D OR EGPS. WE HAD TO ABORT AND USE FLUORO.

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 WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY FLURO DURING SURGERY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED BY HAND DURING SURGERY.

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: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT TUMESCENT-FREE ROBOTIC NIPPLE SPARING MASTECTOMY (NSM) BETWEEN OCTOBER 2020 AND MARCH 2023 AT ONE SINGLE INSTITUTION. THE ARTICLE NOTED THAT AMONG 118 PATIENTS, THAT UNDERWENT ROBOTIC NSM, THIRTY-ONE PATIENTS EXPERIENCED AN ADVERSE EVENT, WITH 8 PATIENTS EXPERIENCING GRADE II OR HIGHER ADVERSE EVENTS, WHICH REQUIRED MORE THAN THE USUAL SYMPTOMATIC CARE. TWO PATIENTS HAD A HEMATOMA AT THE BREAST SURGERY SITE; ONE OF THESE PATIENTS RECEIVED BLEEDING CONTROL IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA, AND THE OTHER PATIENT IMPROVED AFTER A BLOOD TRANSFUSION. TWO PATIENTS HAD NIPPLE-AREOLAR COMPLEX (NAC) NECROSIS, AND BOTH HAD TO UNDERGO NAC REMOVAL. ONE PATIENT HAD SKIN NECROSIS AND UNDERWENT DEBRIDEMENT UNDER LOCAL ANESTHESIA IN THE OPERATING ROOM. TWO PATIENTS EXPERIENCED INFECTION; 1 WAS LOCATED IN THE NAC AND THE OTHER IN THE AXILLA, BOTH OF WHICH IMPROVED AFTER ANTIBIOTIC TREATMENT. THERE WAS NO DA VINCI DEVICE MALFUNCTION MENTIONED IN THE ARTICLE. THE DESIGNATED AUTHOR WAS CONTACTED AND CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION OCCURRED IN ANY OF THE PROCEDURES, AND THE COMPLICATIONS WERE

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 PRIOR TO DOCKING FOR A DA VINCI ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED A BURN AROUND THE CAMERA PORT SITE. THE NURSE CALLED A TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE SURGEON WAS USING A CAMERA IN AN XI CANNULA AND A THIRD-PARTY NONMETAL CANNULA WHEN THE BURN OCCURRED. THE TSE INFORMED THE NURSE THAT CAPACITIVE COUPLING MAY HAVE BEEN THE CAUSE OF THE BURN. INFORMATION REGARDING WHAT TASK WAS BEING PERFORMED WHEN THE EVENT OCCURRED, IF ANY MEDICAL INTERVENTIONS WERE PERFORMED, HOW THE ISSUE WAS RESOLVED, OR THE PATIENT'S STATUS ARE ALL UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

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

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 THE ROSA HUMERAL CLAMP CREATED A HOLE THROUGH THE CORTICAL BONE, AND CAUSED A FRACTURE WHILE IMPLANTING THE STEM. FRACTURE OF THE HUMERUS NEEDED CERCLAGE WIRE AROUND FINAL IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NONE IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE ERBE GENERATOR HAD AN ERROR M-02 ISSUE. PRIOR TO CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CALLER POWER CYCLED THE ERBE GENERATOR WHICH DID NOT SOLVE THE PROBLEM. THE TSE ASKED THE CALLER TO DISCONNECT THE INSTRUMENT ACTIVATION CABLES, REMOVE THE POWER PLUG FROM THE ERBE GENERATOR, AND PUSH THE POWER BUTTON AT THE FRONT. AFTER RESTORING THE POWER AND WITHOUT INSTRUMENTS CONNECTED, THE ERROR CAME BACK IMMEDIATELY. THE TSE ASKED THE CALLER IF THEY COULD USE THE VISION SIDE CART (VSC) FROM THE XI SYSTEM OR IF THEY HAD A FORCETRIAD GENERATOR. THE CALLER STATED THE XI SYSTEM WAS IN USE AND THEY DID NOT HAVE A FORCETRIAD GENERATOR. THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE AFTER PORTS HAD ALREADY BEEN PLACED ON THE PATIENT.

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 SURGICAL PROCEDURE, THE SYNCHROSEAL SHEATHING TORE AND A SMALL SCREW FELL INTO THE PATIENT. THE SCREW WAS RETRIEVED SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE PATIENT WAS NOT HARMED. THE INSTRUMENT HAS BEEN CHECKED BEFORE USE. NO DEFECTS NOR DAMAGE WERE FOUND. PREPARATION WAS CARRIED OUT. THE INSTRUMENT HAD BEEN IN USE FOR SEVERAL HOURS. NO PROBLEMS WITH FUNCTIONALITY WERE DETECTED DURING THE PROCEDURE. THERE WAS NO COLLISION. THE INSTRUMENT WAS REMOVED SEVERAL TIMES DURING THE PROCEDURE. THE WRIST WAS STRAIGHTENED EACH TIME. NO RESISTANCE WAS FELT DURING REMOVAL. THERE WAS NO CANNULA DAMAGE. THE FOREIGN OBJECT COULD BE REMOVED DURING THE PROCEDURE SO THAT THE PATIENT DID NOT HAVE TO BE READMITTED.

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 BRONCHOSCOPY PROCEDURE THERE WAS PATIENT COMPLICATIONS. THE PATIENT HAD SEVERE HYPOXEMIA. THE PHYSICIAN HIT A VESSEL. AFTER REMOVING THE SCOPE THE PATIENT STARTED TO HEMORRHAGE. THE PHYSICIAN STABILIZED THE HEMORRHAGE WITH A MANUAL SCOPE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED AND RELEASED.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED DURING SURGERY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED BY HAND DURING SURGERY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP SCANS SHOWS A SCREW ON THE SAGGITAL AND HAD PERFORATED ANTEROLATERALLY ON THE AXIAL. THIS EVENT OCCURRED IN THE UNITED KINGDOM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CAMERA WAS PLUGGED IN UPON CASE SET UP AND RED "CAMERA BUMP" WARNING APPEARED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WERTHMANN, N. J., GUM, J. L., NAGATA, K., DJURASOVIC, M., GLASSMAN, S. D., OWENS, R. K., CRAWFORD, C. H., <(>&<)> CARREON, L. Y. (2024). COMPARISON OF NO TAP (TWO-STEP) AND TAPPING ROBOTIC ASSISTED CORTICAL BONE TRAJECTORY SCREW INSERTION. JOURNAL OF ROBOTIC SURGERY, 18(1). HTTPS://DOI.ORG/10.1007/S11701-024-01890-1 SUMMARY: WORKFLOW FOR CORTICAL BONE TRAJECTORY (CBT) SCREWS INCLUDES TAPPING LINE-TO-LINE OR UNDER TAPPING BY 1 MM. WE DESCRIBE A NON-TAPPING, TWO-STEP WORKFLOW FOR CBT SCREW PLACEMENT, AND COMPARE THE SAFETY PROFILE AND TIME SAVINGS TO THE TAP (THREE STEP) WORKFLOW. PATIENTS UNDERGOING ROBOTIC ASSISTED 1¿3 LEVEL POSTERIOR FUSION WITH CBT SCREWS FOR DEGENERATIVE CONDITIONS WERE IDENTIFIED AND SEPARATED INTO EITHER A NO-TAP OR TAP WORKFLOW. NUMBER OF TOTAL SCREWS, SCREW-RELATED COMPLICATIONS, ESTIMATED BLOOD LOSS, OPERATIVE TIME, ROBOTIC TIME, AND RETURN TO THE OPERATING ROOM WERE COLLECTED AND ANALYZED. THERE WERE 91 CASES (458 SCREWS) IN THE NO-TAP AND 88 CASES (466 SCREWS) IN THE TAP GROUPS, WITH NO DIFFERENCE IN DEMOGRAPHICS, REVISION STATUS, ASA GRADE, APPROACH, NUMBER OF LEVELS FUSED OR DIAGNOSIS BETWEEN COHORTS. TOTAL ROBOTIC TIME WAS LOWER IN THE NO-TAP (26.7 MIN

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING SURGERY.

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 PATIENT, WHO WAS ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE. APPROXIMATELY THREE MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR A PLANNED ILEOSTOMY TAKEDOWN SURGICAL PROCEDURE AND WAS DISCHARGED ON POST-OPERATIVE DAY #4. ON POST-OPERATIVE DAY #11, DURING A FOLLOW-UP VISIT, THE PATIENT COMPLAINED OF UPPER ABDOMINAL PAIN WITH TENDERNESS UPON PALPATION. IT IS UNKNOWN IF THE PATIENT WAS ABLE TO PASS STOOL. A KUB X-RAY SHOWED INTESTINAL GAS. GASTRIC MEDICATION WAS PRESCRIBED AND SCHEDULED A FOLLOW-UP IN A WEEK. DUE TO PERSISTENT ABDOMINAL PAIN AND COLD SWEATS, THE PATIENT VISITED THE EMERGENCY ROOM IN THE SAME EVENING. THE ABDOMEN WAS SOFT BUT PAINFUL UPON PRESSURE. BLOOD TESTS SHOWED ELEVATED WBC AND CRP, AND LOW POTASSIUM. KUB AND ABDOMINAL CT SCANS INDICATED GAS AND FLUID IN THE UPPER ABDOMEN, SUGGESTING A MINOR ANASTOMOTIC LEAK. THE RECTAL DEPARTMENT WAS CONSULTED AND RECOMMENDED FASTING, IV FLUIDS, ANTIBIOTICS, MONITORING VITAL SIGNS, AND HOSPITAL ADMISSION. THE NEXT DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL, RECEIVING ANTIBIOTICS AND NUTRITIONAL IV, AND FASTING. ON POST-OPERATIVE DAYS #13 THROUGH #17, THE PATIENT REPORTE

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 HARMONIC ACE INSTRUMENT SHEARS FRACTURED. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT, WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE SHEAR OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. A LEFT HEMICOLECTOMY PROCEDURE WAS BEING PERFORMED WHEN THE ISSUE OCCURRED. THERE WERE NO INSTRUMENT COLLISIONS DURING THE PROCEDURE. A FRAGMENT DID FALL INSIDE OF THE PATIENT; IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT IS AVAILABLE FOR RETURN. THE REPORTED FRAGMENT IS NOT AVAILABLE FOR RETURN.

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 CLINICAL ARTICLE THAT ASSESSED THE EFFECTIVENESS AND SAFETY OF ROBOTIC SECTIONECTOMY (RS) VERSUS ROBOTIC (EXTENDED) HEMIHEPATECTOMY (RH) FOR THE TREATMENT OF LIVER TUMORS WAS REVIEWED. THE STUDY INCLUDED 30 PATIENTS BETWEEN MARCH 2021 AND JULY 2023 THAT UNDERWENT HEPATECTOMIES IN ONE SINGLE INSTITUTION. A TOTAL OF 16 PATIENTS UNDERWENT RS, AND 14 PATIENTS UNDERWENT RH. AMONG THE 30 PATIENTS, ONE PATIENT IN EACH STUDY GROUP WAS CONVERTED TO OPEN HEPATECTOMY DUE TO ONCOLOGICAL SAFETY (ONE PATIENT WITH A BISMUTH TYPE IIIB PERIHILAR CHOLANGIOCARCINOMA WHO WAS ADMITTED FOR LEFT HEPATECTOMY BUT UNDERWENT EXTENDED LEFT HEPATECTOMY) AND DUE TO MULTIPLE ADHESIONS (ONE PATIENT WITH RECURRENT COLORECTAL LIVER METASTASES AFTER NON-ANATOMIC SEGMENT II RESECTION WHO WERE ADMITTED FOR LEFT LATERAL SECTIONECTOMY). THERE WAS NO INTRAOPERATIVE COMPLICATIONS MENTIONED IN THE ARTICLE. POST-OPERATIVELY, A TRANSIENT POSTHEPATECTOMY LIVER FAILURE, WHICH WAS ASSESSED AS INTERNATIONAL STUDY GROUP OF LIVER SURGERY(ISGLS) GRADE A, WAS REPORTED IN ONE PATIENT AFTER AN EXTENDED RIGHT HEPATECTOMY. POSTHEPATECTOMY BILE LEAKS (ISGLS GRADE B) WERE OBSERVED IN ONE PATIENT IN THE RH GROUP AND THREE PATIENTS IN THE

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 TRANSTHORACIC ESOPHAGECTOMY WITH NECK ANASTOMOSIS PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS FOUND TO BE BROKEN. AN UNSPECIFIED RADIOLOGICAL TEST WAS PERFORMED TO CHECK THE PATIENT AND NO FOREIGN BODY WAS FOUND. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY, A SEROMA WAS NOTED ON THE RIGHT ON POST-OPERATIVE DAY 34. AN ASPIRATION CULTURE OF THE SEROMA INDICATED A SERRATIA BACTERIAL INFECTION WHICH WAS TREATED WITH ORAL ANTIBIOTICS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED, AND THE SEROMA WAS NOT YET RESOLVED. THERE WAS NO REPORT OF DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY TO COMPARE THE OUTCOMES OF 96 PATIENTS UNDERGOING ROBOTIC-ASSISTED RADICAL CYSTECTOMY (RARC) WITH URINARY DIVERSION FOR BLADDER CANCER. THE STUDY AIMED TO EVALUATE THE POSTOPERATIVE OUTCOMES AND ANALGESIC REQUIREMENTS OF SINGLE-PORT (SP) VS MULTIPORT ROBOTIC-ASSISTED RADICAL CYSTECTOMY (MP RARC). IN THE SP COHORT, THERE WERE SEVEN CLAVIEN IV COMPLICATIONS (TWO CARDIAC ARRHYTHMIAS AND SHOCK, THREE SEPTIC SHOCKS, ONE RESPIRATORY FAILURE, AND ONE BOWEL PERFORATION), AND FOUR CLAVIEN III COMPLICATIONS (ONE INCISIONAL HERNIA REPAIR, ONE GASTRIC TUBE PLACEMENT FOR CANCER RECURRENCE, ONE HYDRONEPHROSIS WITH ASSOCIATED ACUTE KIDNEY INJURY REQUIRING A NEPHROSTOMY TUBE, AND ONE INTRAABDOMINAL ABSCESS REQUIRING DRAIN PLACEMENT) WERE NOTED. THE STUDY CONCLUDED THAT THE SP ROBOTIC PLATFORM OFFERS A SAFE ALTERNATIVE TO THE MP ROBOTIC PLATFORM IN PERFORMING RARC WITH URINARY DIVERSION. NO CLINICALLY SIGNIFICANT DIFFERENCE WAS DEMONSTRATED IN PERIOPERATIVE OR ONCOLOGIC OUTCOMES. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ANY INTUITIVE PRODUCTS CAUSED OR CONTRIBUTED TO THE INJURIES. THE DESIGNATED AUTHOR

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

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 THE TIP OF THE REAMER WAS 6MM TOO POSTERIOR COMPARED TO PLAN. THE SURGEON HAD TO GRAFT THE HOLE AND REAMED AGAIN WITH CONVENTIONAL INSTRUMENTATION TO PREPARE THE CENTRAL HOLE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

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 THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY WHICH HAD TO BE CANCELLED DURING THE PROCEDURE AS THE DISTAL RESECTION RESULTED IN SEVERE VALGUS.ALL LANDMARKS WERE TAKEN CORRECTLY AND NO DRIFTING OCCURRED DURING THE RESECTION. THE BONE HAD TO BE REBUILT WITH WEDGES. THERE WAS A 30 (THIRTY) MINUTE DELAY TO REBUILD THE BONE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: HTTPS://DOI.ORG/10.1016/J.WNSX.2024.100390 SUMMARY: BACKGROUND: ROBOTIC-ASSISTED, ENDOSCOPIC TRANSFORAMINAL LUMBAR INTERBODY FUSION (RE-TLIF) IS A PROMISING, MINIMALLY INVASIVE SURGICAL OPTION FOR DEGENERATIVE LUMBAR SPONDYLOSIS/SPONDYLOLISTHESIS; HOWEVER, OUTCOMES DATA AND EFFICACY ARE LIMITED, ESPECIALLY IN MULTILEVEL DISEASE. HERE, WE PRESENT THE FIRST REPORTED SERIES OF PATIENTS THAT UNDERWENT EITHER SINGLE OR MULTILEVEL RE-TLIF. METHODS: A RETROSPECTIVE REVIEW WAS PERFORMED ON 23 CONSECUTIVE PATIENTS WHO UNDERWENT A SINGLE LEVEL OR MULTILEVEL RE-TLIF BY A SINGLE SURGEON. VARIABLES INCLUDED DEMOGRAPHICS, PERIOPERATIVE RESULTS, PAIN SCORES, AND FUNCTIONAL OUTCOME SCORES. RESULTS: EIGHTEEN PATIENTS (78.3 %) UNDERWENT SINGLE LEVEL RE-TLIF AND 5 PATIENTS (21.7 %) UNDERWENT MULTILEVEL RE-TLIF. THE MEDIAN REDUCTION OF VISUAL ANALOG SCALE (VAS) FOR LOW BACK PAIN (LBP) OF ALL SUBJECTS WAS 6 (IQR = 4.5, 6.5) WITH NO SIGNIFICANT DIFFERENCE BETWEEN SINGLE LEVEL AND MULTILEVEL RE-TLIF (P = 0.565). THE MEDIAN REDUCTION OF VAS FOR LEG PAIN OF ALL SUBJECTS 7 (IQR = 6, 8) WITH NO SIGNIFICANT DIFFERENCE BETWEEN SINGLE LEVEL AND MULTILEVEL RE-TLIF (P = 0.702). MEDIAN BLOOD LOSS WAS 25

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 PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE PAD ON THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE PAD WAS COMPLETELY REMOVED USING A LAPAROSCOPIC INSTRUMENT AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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 SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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 LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE SINGLE-INSTITUTION STUDY, AN EVALUATION OF PATIENTS WHO HAD UNDERGONE ROBOTIC LUNG RESECTION FOR LUNG ADENOCARCINOMA WAS PERFORMED. THE AIM OF THE STUDY WAS TO EXAMINE THE USEFULNESS OF FINAL TRANSECTION OF THE PROXIMAL PULMONARY ARTERY IN ROBOTIC LEFT UPPER LOBECTOMY AND ITS IMPACT ON PERIOPERATIVE OUTCOMES. THE STUDY TOOK PLACE BETWEEN JANUARY 2017 AND NOVEMBER 2022, DURING WHICH 49 PATIENTS UNDERWENT ROBOTIC LEFT UPPER LOBECTOMY. THE MEDIAN AGE OF THE PATIENTS WAS 69.5 YEARS IN THE BRONCHUS PRIOR TRANSECTION GROUP (BT GROUP) AND 74 YEARS IN THE ARTERY PRIOR TRANSECTION GROUP (AT GROUP). THE GROUPS DID NOT DIFFER SIGNIFICANTLY IN PREOPERATIVE FACTORS, INCLUDING AGE, SEX, SMOKING STATUS, BASELINE FUNCTION, CLINICAL TUMOR SIZE OR NODAL STATUS. TWO PATIENTS IN THE AT GROUP EXPERIENCED INTRAOPERATIVE BLEEDING. ONE PATIENT'S MOST PROXIMAL BRANCH OF THE PULMONARY ARTERY WAS INJURED WHEN THE ARTERY WAS BEING TRANSECTED WITH A STAPLER BY AN ASSISTANT SURGEON. A CONVERSION TO THORACOTOMY WAS PERFORMED, AND THE LEFT MAIN PULMONARY ARTERY WAS CLAMPED. THE INJURY WAS SUTURED USING 6-0 PROLENE. THE PATIENT LOST 2460 ML OF BLOOD AND REQUIRED A BLO

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 UROLOGY SURGICAL PROCEDURE, AN ERROR OCCURRED WHEN THE ENDOSCOPE WAS CONNECTED TO THE ENDOSCOPIC CONTROLLER (EC). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) SUGGESTED DISCONNECTING THE ENDOSCOPE CONTROLLER AND POWER CYCLE THE SYSTEM INCLUDING A HARD POWER CYCLE AND EMERGENCY POWER OFF (EPO) ON THE PATIENT SIDE CART (PSC); THIS DID NOT SOLVE THE PROBLEM. THEN, TAKING THE PICTURE OF THE EVENT LOGS AND SENDING THEM TO TECHNICAL SUPPORT AND IN PARALLEL GUIDED THE CALLER TO FIND LINE WITH ERROR 319 AND GET THE P1 VALUE WAS SUGGESTED AND TO CHECK THE SOFTWARE VERSION OF THE SYSTEM. THE PICTURE WITH THE EVENT LOGS DID NOT COME IN. THE BIOMED PERFORMED SEVERAL HARD POWER CYCLES, EPO ON THE PSC, AND POWER CABLE DISCONNECT BUT NONE SOLVED THE PROBLEM. FURTHER LOG REVIEW SHOWED ERRORS ON THE PCC 3 ON THE UCC. THE TSE INFORMED THE CUSTOMER THAT THE SYSTEM NEEDED TO BE REPAIRED. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE. THERE WERE NO ERRORS NOTED. ADDITIONAL PORTS WERE PLACED. INS

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 LITERATURE ARTICLE DESCRIBED ANALYSIS OF A RETROSPECTIVE COHORT STUDY INVESTIGATING THE IMPACT OF MARITAL STATUS ON PERIOPERATIVE OUTCOMES IN PATIENTS UNDERGOING ROBOTIC-ASSISTED PULMONARY LOBECTOMY (RAPL) FOR NON-SMALL CELL LUNG CANCER (NSCLC). THE STUDY OCCURRED FROM SEPTEMBER 2010 TO MARCH 2022, DURING WHICH 709 PATIENTS UNDERWENT RAPL. OF THE 709 SURGERIES, IT WAS REPORTED THAT THERE WERE 40 INTRAOPERATIVE COMPLICATIONS, 32 OF WHICH WERE ROBOTIC-ASSOCIATED INTRAOPERATIVE COMPLICATIONS. THE COMPLICATIONS INCLUDED PULMONARY ARTERY BLEEDING, PULMONARY VEIN BLEEDING, "OTHER" BLEEDING, TRACHEAL/BRONCHIAL INJURIES, A DIAPHRAGM INJURY, AND A PHRENIC NERVE INJURY. PERIOPERATIVE OUTCOMES INCLUDED AT TOTAL OF 39 OVERALL CONVERSIONS TO THORACOTOMY, 15 OF WHICH WERE URGENT CONVERSIONS. IN-HOSPITAL MORTALITY RATES WERE LOW IN BOTH GROUPS. THE DESIGNATED AUTHOR HAS CONFIRMED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS, AND THAT NO DA VINCI DEVICES CAUSED OR CONTRIBUTED TO ANY OF THE REPORTED COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, SYNCHROSEAL INSTRUMENT PAINT LAYER WAS PEELED OFF. THE PROCEDURE WAS COMPLETING AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE DAMAGED FRAGMENT WAS FOUND IN THE BODY CAVITY BUT WAS REMOVED DIRECTLY FROM THE BODY CAVITY.

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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DISPLAYED AN ERROR MESSAGE AND COULD NOT BE USED. THE ISI TSE CHECKED LOGS AND NOTED ERRORS M-12. THE ISI TSE ASKED THE CUSTOMER TO CHECK THE EXTREMAL FOOT PEDALS IN A DRAWER AND ENSURE THEY WERE NOT PUSHED OR STUCK; THE CUSTOMER INFORMED THEY HAD ALREADY DONE SO AND VERIFIED NOTHING PUSHING ON THE PEDALS. THE ISI TSE GUIDED THE CUSTOMER TO DISCONNECT THE EXTERNAL FOOT PEDALS FROM ERBE'S REAR PANEL AND THE ERROR CLEARED. THE ISI TSE INFORMED THE CUSTOMER THAT THE ISI FSE WOULD VISIT TO RESOLVE THE ISSUE PERMANENTLY. THE CUSTOMER CALLED BACK AND REPORTED ERROR HAD RETURNED; THE ERROR MESSAGE RETURNED WHEN THE BIPOLAR EXTERNAL PEDAL WAS PLUGGED IN AND WHEN THE MONOPOLAR WAS DISCONNECTED, THE SURGEON COULD NOT CONTROL ERBE FROM THE SURGEON SIDE CONSOLE (SSC). THE ISI TSE SUGGESTED VERIFYING THE CORRECT CONNECTORS WERE DISCONNECTED, THE CUSTOMER DID SO. THE CUSTOMER NEEDED IESU FOR THE PROCEDURE, SO THE PROCEDURE WAS MOST LIKELY TO BE CONVERTED. THE ISI

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 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 TRANSANAL TOTAL MESORECTA EXCISION SURGICAL PROCEDURE, THE HARMONIC ACE TIP BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED INSIDE THE PATIENT. THE SURGEON STATED THAT THERE WAS NO INSTRUMENT COLLISION. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER USED A LAPAROSCOPIC INSTRUMENT TO RETRIEVE THE FRAGMENT. ALL FRAGMENTS WERE RETRIEVED; NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE ANY FRAGMENTS. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON WAS NOT AWARE OF WHAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS IN USE FOR ABOUT 15 MINUTES WHEN THE ISSUE WAS IDENTIFIED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE ISSUE WAS IDENTIFIED DURING THE DISSECTION; THERE WERE NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT NOTED PRIOR TO THE REPORTED ISSUE. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING INSTRUMENT TIP INSPECTION.

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 BLADE BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED.