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: A LITERATURE DESCRIBED A STUDY AIMED TO EVALUATE SEXUAL AND REPRODUCTIVE OUTCOMES OF 22 PATIENTS FOLLOWING POST-CHEMOTHERAPY ROBOT-ASSISTED RETROPERITONEAL UNILATERAL LYMPH NODE DISSECTION (PC-RRPLND) FOR NON-SEMINOMATOUS GERM CELL TUMORS (NSGCTS) AT A HIGH-VOLUME CANCER CENTER. AMONG THE PATIENTS INCLUDED IN THE STUDY, AN INTRAOPERATIVE COMPLICATION (VENA CAVA INJURY) WAS RECORDED, WITHOUT NEEDING PERIOPERATIVE BLOOD TRANSFUSION. NONE OF THE PATIENTS EXPERIENCED LATE POST-OPERATIVE COMPLICATIONS. RETROGRADE EJACULATION IS CONFIRMED TO BE ONE OF THE MOST COMMON COMPLICATIONS OF PC-RRPLND. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE USING A HARMONIC ACE INSTRUMENT, THE BLADE BROKE, RESULTING IN POOR CUTTING AND A FRAGMENT FALLING INSIDE THE PATIENT. THE SURGEON WAS CUTTING THE LIVER PARENCHYMA WHEN A PIECE OF THE INSTRUMENT'S BLADE BROKE OFF INSIDE THE PATIENT. THE BLADE PIECE WAS RETRIEVED WITH A LAPAROSCOPIC FORCEPS. THE PROCEDURE WAS CONTINUED WITH A BACKUP HARMONIC ACE INSTRUMENT. THE STAFF CONFIRMED ALL PIECES WERE RETRIEVED BY CHECKING THE FRAGMENT OF THE DAMAGED BLADE AND ALIGNING IT WITH THE HARMONIC ACE INSTRUMENT BODY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORT OF INJURY.

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 SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BLADE FRACTURED. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CITATION: SRINIVASA, V., THIRUGNANAM, B., PAI KANHANGAD, M., SONI, A., KASHYAP, A., VIDYADHARA, A., & RAO, S. K. (2024). FLATTENING THE LEARNING CURVE ¿ EARLY EXPERIENCE OF ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT IN SPINE SURGERY. JOURNAL OF ORTHOPAEDICS, 57, 49¿54. HTTPS://DOI.ORG/10.1016/J.JOR.2024.06.011. SUMMARY: AIMS AND OBJECTIVES: TO DETERMINE ACCURACY OF PEDICLE SCREWS PLACED BY FREEHAND, FLUOROSCOPY-ASSISTANCE AND ROBOTIC-ASSISTANCE WITH INTRAOPERATIVE IMAGE ACQUISITION, AND DETERMINE THE PRESENCE OF LEARNING CURVE IN ROBOTIC SPINE SURGERY IN A PROSPECTIVE SINGLE CENTRE STUDY. MATERIALS AND METHODS: IN A PROSPECTIVE STUDY, A TOTAL OF 1120 PEDICLE SCREWS WERE PLACED IN FREEHAND GROUP (N = 175), 1250 SCREWS WERE PLACED IN FLUOROSCOPY ASSISTED GROUP (N = 172), AND 1225 SCREWS WERE INSERTED IN ROBOTIC-ASSISTED GROUP(N = 180). SURGICAL PARAMETERS AND SCREW ACCURACY WERE ANALYZED BETWEEN THE THREE GROUPS. THE PREOPERATIVE PLAN WAS OVERLAPPED WITH POST OPERATIVE O-ARM SCAN TO DETERMINE IF THE SCREWS WERE EXECUTED AS PLANNED. RESULTS: THE FREQUENCY OF CLINICALLY ACCEPTABLE SCREW PLACEMENT (GERTZBEIN AND ROBBINS GRADE A, B) IN THE FREEHAND, FLUOROSCOPY-ASSISTED, AND ROBOTIC-ASSIST

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 ENERGY CABLE WAS UNABLE TO TRANSMIT ENERGY. THE USER CONVERTED TO OPEN SURGERY WITH A PROCEDURE DELAY GREATER THAN 30 MINUTES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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: 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.

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 DURING THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A BLEED. THE PHYSICIAN REPORTED THE BLEEDING WAS NOT DUE TO MONARCH BUT RATHER JUST A RISK OF BIOPSYING THIS SPECIFIC PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION ONLY.

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 MYOMECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT, FELL INSIDE THE PATIENT'S PELVIS. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY AND THE CUSTOMER CONFIRMED ALL PIECES WERE RETRIEVED BY A VISUAL INSPECTION. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WILL NOT BE RETURNED FOR FAILURE ANALYSIS EVALUATION. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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: A LITERATURE ARTICLE DESCRIBED A STUDY THAT AIMED TO ANALYZE THE OUTCOMES OF 29 PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED REVISIONAL ROUX-EN-Y GASTRIC BYPASS (RRYGB) SURGERIES FROM JANUARY 2016 TO FEBRUARY 2023 IN ONE SINGLE INSTITUTION. THE ARTICLE NOTED THAT AMONG THESE SURGERIES, ONE PATIENT EXPERIENCED A POST-OPERATIVE COMPLICATION OF JEJUNOJEJUNAL STENOSIS AND WAS RESOLVED BY REDOING THE JEJUNO-JEJUNAL ANASTOMOSIS LAPAROSCOPICALLY. THERE WERE NO POSTOPERATIVE ANASTOMOTIC LEAKS OR INCIDENCE OF HEMORRHAGE. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE NOR ANY MORTALITY IN THE COHORT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE WAS A RED TAG ERROR DURING CASE SET UP. "PIB HARDWARE COMMUNICATION STOPPED."

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.

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. 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: A LITERATURE ARTICLE DESCRIBED AN OBSERVATIONAL COHORT STUDY WHICH WAS TO ASSESS THE IMPACT OF A PROFICIENCY-BASED PROGRESSION TRAINING CURRICULUM ON PERI-OPERATIVE AND SURVIVAL OUTCOMES FOR ENDOMETRIAL CANCER. THE STUDY OCCURRED FROM 2015 TO 2022 AND INCLUDED 594 WOMEN DIAGNOSED WITH PRIMARY ENDOMETRIAL CANCER TREATED WITH ROBOT-ASSISTED LAPAROSCOPIC SURGERY, WHICH TYPICALLY INVOLVED HYSTERECTOMY AND SALPINGO-OOPHORECTOMY ALONG WITH SOME FORM OF PELVIC LYMPH NODE DISSECTION. THE ARTICLE STATED MANY INTRAOPERATIVE COMPLICATIONS, WHICH WERE SLIGHTLY LOWER IN THE NON-TRAINING GROUP AT 4.8% COMPARED TO 7.7% IN THE TRAINING GROUP. GRADES 3A AND 3B COMPLICATIONS OCCURRED AT SIMILAR LOW FREQUENCIES ACROSS BOTH GROUPS, WHILE GRADE 4A COMPLICATIONS WERE EQUALLY RARE AT 0.7% IN BOTH GROUPS. READMISSION RATES WITHIN 30 DAYS WERE LOWER IN THE TRAINING GROUP (3.8%) COMPARED TO THE NON-TRAINING GROUP (6.0%). RETURNS TO THE THEATER WERE INFREQUENT IN BOTH GROUPS, OCCURRING AT 1.0% IN THE TRAINING GROUP AND 1.7% IN THE NON-TRAINING GROUP. LYMPHOEDEMA RATES WERE ALSO COMPARABLE, NOTED AT 8.4% IN THE TRAINING GROUP VERSUS 11.3% IN THE NON-TRAINING GROUP. THERE WERE NO DA VINCI DEVICE ISSUES MENTION

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 PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLISM (PE) ALONG WITH RIGHT VENTRICULAR STRAIN ON POSTOPERATIVE DAY ONE AND WAS IN CRITICAL CONDITION. THE PATIENT'S CURRENT STATUS IS UNKNOWN. THE INITIAL PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INTRAOPERATIVE COMPLICATIONS OR MALFUNCTION OF THE DA VINCI SYSTEM. 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: IT WAS REPORTED DURING SURGERY OF A BIOPSY AND LITT PROCEDURE, THE FIDUCIAL REGISTRATION WAS PERFORMED. THE BIOPSY AND PLACEMENT OF THE LITT BOLT OCCURRED WITHOUT INCIDENT. DURING THE INTRAOPERATIVE MRI SCAN TO BEGIN THE LITT ABLATION, SURGEON NOTICED WHAT APPEARED TO BE A HEMORRHAGE IN THE PATIENT'S TEMPORAL LOBE NEAR THE LASER FIBER. SURGEON TRANSITIONED THE SURGERY TO AN OPEN CRANIOTOMY TO TREAT THE HEMORRHAGE. REPORTER IS CURRENTLY UNAWARE AT THIS TIME OF THE PATIENT'S CONDITION AFTER SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE 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: A RETROSPECTIVE, COHORT STUDY WHICH DESCRIBED A COMPARISON BETWEEN ROBOTIC SINGLE-SITE (RSS) AND MULTIPORT LAPAROSCOPIC (MPL) SURGERY, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE AIM OF THE STUDY WAS TO COMPARE RSS SURGERY TO MULTIPORT LAPAROSCOPIC SURGERY IN TERMS OF SURGICAL OUTCOMES AND OVERALL SURVIVAL FOR PATIENTS WITH EARLY ENDOMETRIAL CANCER. THE STUDY OCCURRED FROM MARCH 2014 TO DECEMBER 2022 AND INCLUDED A TOTAL OF 421 PATIENTS OF WHICH 146 UNDERWENT RSS SURGERY WITH A MEDIAN AGE OF APPROXIMATELY 51.95 YEARS AND A MEDIAN BMI OF 24.82. ALL PATIENTS WERE FEMALE AS THE STUDY INVOLVED ENDOMETRIAL CANCER PATIENTS. THE ARTICLE NOTED THAT DURING THESE SURGERIES, PERIOPERATIVE COMPLICATIONS OCCURRED INCLUDING: ONE CASE OF AN INCISIONAL HERNIA, ONE CASE OF LYMPHOCELE, ONE CASE OF RECTUM TEAR, ONE OCCURRENCE OF VAGINAL CUFF BLEEDING, ONE CASE OF VAGINAL CUFF DISRUPTION, AND ONE CASE OF VAGINAL CUFF INFECTION. THERE WERE NO REPORTS OF ANY DA VINCI DEVICE MALFUNCTIONS NOR WERE THERE ANY ALLEGATIONS THAT ANY INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE DESIGNATED AUTHOR; HOWEVER, NO RESPONSE WAS RECEIV

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 CHEST ANASTOMOSIS ESOPHAGECTOMY TRANSTHORACIC SURGICAL PROCEDURE THAT THE TIP OF THE HARMONIC ACE INSTRUMENT WAS FOUND TO BE LOOSE. REPORTEDLY A FRAGMENT FELL INTO THE PATIENT BUT WAS RETRIEVED DURING THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED ROBOTICALLY.

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 LYMPHADENECTOMY PROCEDURE, A SMALL PIECE OF THE UNIVERSAL CANNULA SEAL BROKE OFF INTO THE PATIENT. THE CUSTOMER WAS ABLE TO SUCCESSFULLY RETRIEVE THE PIECE DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED AS PLANNED.

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 THAT EVALUATED THE PREOPERATIVE FINDINGS AND SURGICAL RESULTS OF THYMIC CYSTS SURGICALLY TREATED WITH ROBOTIC APPROACH WAS REVIEWED. THE STUDY INCLUDED 57 PATIENTS THAT UNDERWENT ROBOTIC SURGERY FOR THYMIC CYSTS IN THREE ITALIAN THORACIC SURGERY CENTERS BETWEEN MARCH 2014 AND APRIL 2022. SURGICAL PROCEDURES WERE ROBOTIC APPROACH IN ALL CASE INCLUDING 35 TOTAL/EXTENDED THYMECTOMY AND 22 CYST RESECTION/PARTIAL THYMECTOMY 22. IN ALL CASES, THE CYSTS WERE COMPLETELY REMOVED USING THE ROBOTIC APPROACH, WITH NO INSTANCES REQUIRING CONVERSION TO THORACOTOMY OR STERNOTOMY, AND NO INTRAOPERATIVE COMPLICATIONS WERE OBSERVED. THREE POSTOPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE. ONE CASE REQUIRED REOPERATION FOR THORACIC DUCT CLOSURE DUE TO CHYLOTHORAX, ANOTHER CASE OF POSTOPERATIVE ANEMIA WAS MANAGED CONSERVATIVELY THROUGH BLOOD TRANSFUSION, AND A THIRD CASE OF POSTOPERATIVE RESPIRATORY FAILURE WAS EFFECTIVELY TREATED WITH NON-INVASIVE VENTILATION. THERE WERE NO POSTOPERATIVE MORTALITIES OBSERVED. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS

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 MONARCH BRONCHOSCOPY PROCEDURE THE ARMS WERE STUCK IN STOW POSITION AND WILL NOT RESPOND. THE PHYSICIAN POWER CYCLED THE MONARCH SYSTEM A COUPLE OF TIMES AND RECONNECTED THE SYSTEM; HOWEVER, THERE WAS NO CHANGE. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULE FOR A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EVENT DUE TO SYSTEM ISSUES.

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.