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.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT DIED OF A PULMONARY EMBOLISM ON AN UNSPECIFIED DATE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT HAD A FAST INITIAL POST-OPERATIVE RECOVERY. THE SURGEON AND THE HOSPITAL TEAM DO NOT THINK THIS IS DIRECTLY RELATED TO THE DA VINCI SINGLE PORT (SP) SYSTEM USED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON AND A RESPONSE IS PENDING.

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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A BLACK VALVE WAS BROKEN ON THE THIRD PORT CANNULA AND FELL INTO THE PATIENT. THE VALVE WAS THOUGHT TO BE FROM THE UNIVERSAL SEAL, BUT THE CUSTOMER CONTINUED TO USE THE PRODUCT WITHOUT REPLACEMENT. THE OPERATION WAS TERMINATED. THERE WAS NO BLEEDING DUE TO THE ISSUE NOR ANY TISSUE/VASCULAR DAMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CLARIFIED THAT THE FRAGMENTS WERE RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT, AND THEY CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED USING THE ENDOSCOPE. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED, THERE WAS A POST-OPERATIVE TEST DONE. THE CUSTOMER COMPLETED THE PROCEDURE ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY COMPLICATIONS. THE ACCESSORY IS NOT AVAILABLE FOR RETURN AND THE FRAGMENT WAS DISCARDED.

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 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: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE PATIENT HAD A POST-OPERATIVE PULMONARY EMBOLISM; THE SURGEON OF THE PROCEDURE REPORTED THAT THE PATIENT ALMOST DIED. THE PROCEDURE WAS FOUR HOURS LONG AND WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON SAID THE EMBOLISM WAS NOT RELATED TO THE USE OF THE DA VINCI SINGLE PORT (SP) SYSTEM. THE SURGEON WAS BEING PROCTORED THIS PROCEDURE. THE SURGEON REPORTED THAT THE PATIENT RECEIVED NORMAL THROMBOSIS PROPHYLAXIS WITH TIGHT SOCKS AND LOW MOLECULAR HEPARIN POSTOPERATIVELY FROM OR-DAY AND ONWARDS (HOSPITAL STANDARD). THE PATIENT EXPERIENCED A THROMBOEMBOLIC PULMONAL EMBOLISM CENTRALLY WITH PAIN AND DIFFICULTIES TO BREATH WITHOUT A FULMINANT EVENT TWO DAYS AFTER SURGERY. THE PATIENT EXPERIENCED DIFFICULTIES TO RECOVER APPROPRIATELY AFTER SURGERY AND DID NOT FEEL WELL. THE EMBOLISM WAS CONFIRMED WITH A CT-SCAN OF THE THORAX AND ELEVATED D-DIMER SCORES. THE PATIENT RECEIVED CONSERVATIVE TREATMENT WITH HEPARIN ON A THERAPEUTIC LEVEL. THE PATIENT DEVELOPED A RETRO-VESICAL HEMATOMA AND INSUFFICIENCY OF THE ANASTOMOSIS WITH SEVERAL TRANSFUSIONS. THE PATIENT WAS PLACED IN THE INTENSIVE CARE

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: DESCRIPTION OF EVENT ON (B)(6) 2024, THE PATIENT UNDERWENT A ROBOTIC-ASSISTED PARTIAL HYSTERECTOMY UTILIZING THE DA VINCI ROBOTIC SURGICAL SYSTEM AT (B)(6) MEDICAL CENTER IN (B)(6). FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SEVERE AND LIFE-THREATENING POSTOPERATIVE COMPLICATIONS, INCLUDING: SEPSIS, MULTIPLE ORGAN DAMAGE, SEVERE INFECTION LEADING CHRONIC LONG-TERM INFECTIONS, PROLONGED HOSPITALIZATION, ADDITIONAL SURGEONS, COVERING 4 MAJOR BODY SYSTEMS, PERMANENT PHYSICAL IMPAIRMENT AND SEVERE EMOTIONAL MEDICAL ANXIETY. THE SEVERITY AND PROGRESSION OF THESE COMPLICATIONS RAISES SIGNIFICANT CONCERNS REGARDING POTENTIAL DEVICE-RELATED INJURY, DELAYED RECOGNITION OF INTRAOPERATIVE INJURY, OR POSSIBLE MALFUNCTION OR LIMITATIONS ASSOCIATED WITH THE ROBOTIC SURGICAL SYSTEM. DEVICE-RELATED CONCERNS BASED ON MEDICAL RECORDS AND POSTOPERATIVE CLINICAL COURSE, THE FOLLOWING CONCERNS REQUIRE INVESTIGATION: 1. POSSIBLE DEVICE MALFUNCTION THERE IS CONCERN THAT THE DA VINCI ROBOTIC SURGICAL SYSTEM MAY HAVE EXPERIENCED MALFUNCTION, CALIBRATION ERROR, OR MECHANICAL OR SOFTWARE-RELATED PERFORMANCE ISSUES DURING THE PROCEDURE. 2. INADEQUATE VISUALIZATION THERE IS CONCERN THAT VISUALIZATION PRO

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 CUSTOMER REPORTED THEY HAD ISSUES WITH THE UNIVERSAL SEAL. THE CUSTOMER REPORTED ONE OF THE UNIVERSAL SEALS CAME APART AND A PIECE OF THE RUBBER FELL OFF INTO THE ABDOMEN OF THE PATIENT. THE PIECE WAS RECOVERED DURING THE SAME PROCEDURE. ADDITIONALLY, DURING THE SAME PROCEDURE, ONE OF THE OTHER UNIVERSAL SEALS HAD THE PLASTIC INSUFFLATION PORT BREAK OFF. THERE WAS NO MENTION OF ANY FRAGMENT FALLING INSIDE THE PATIENT WITH THE SECOND UNIVERSAL SEAL. THE CUSTOMER WAS NOT ABLE TO RECORD THE LOT NUMBER OF THE SEALS USED BUT THEY WILL BE SENDING THE DAMAGED ONES BACK FOR INVESTIGATION. BOTH SEALS WERE REMOVED AND REPLACED AND THEY WERE ABLE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS ABLE TO REMOVE ALL FRAGMENTS PER THE STAFF REPORT. THE REPORTER STATED THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WAS NO POST-OPERATIVE TEST LIKE AN X-RAY OR ULTRASOUND TO CHECK FOR REMAINING FRAGMENTS. 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: THE CAMERA WAS PLUGGED IN AND THE 'CAMERA BUMP' WARNING APPEARED. THE CASE WAS CANCELLED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE THAT ADDRESSES THE POSSIBLE BENEFITS OF NERVE MONITORING DURING DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURES, THE FOLLOWING COMPLICATIONS WERE MENTIONED: THE STUDY WITH 100 PATIENTS ENROLLED, EXAMINED THE BENEFITS OF USING A NERVE MONITORING SYSTEM DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY (THE INTERVENTION ARM) VERSUS THE STANDARD OF CARE (THE CONTROL GROUP). AVAILABLE FOR FINAL ANALYSIS AT 12 MONTHS 82 PATIENTS REMAINED IN THE STUDY, 41 PATIENTS IN EACH GROUP. THERE WERE EIGHT CLAVIEN-DINDO GRADE GREATER THAN OR EQUAL TO III COMPLICATIONS, ONE CASE OF SEVERE MESENTERIC BLEEDING, ONE RECTAL LESION, AND ONE SPHINCTERIC LESION, ALL IN THE CONTROL GROUP. THERE WERE FIVE CASES OF ANASTOMOSIS LEAKAGE, TWO IN THE INTERVENTION GROUP AND THREE IN THE CONTROL GROUP. WE DETECTED NERVE SIGNALS DURING MONITORING IN ALL PARTICIPANTS IN THE INTERVENTION GROUP BEFORE THE REMOVAL OF THE PROSTATE. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN SURGICAL TIME OR BLOOD LOSS. THERE WAS NO REPORT IN THE ARTICLE THAT A DA VINCI DEVICE MALFUNCTIONED DURING THE PROCEDURES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL

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 SYNCHROSEAL ¿SCREW¿ CAME OFF. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE SCREW FELL INTO THE PATIENT¿S ANATOMY WHEN THE INSTRUMENT WAS BEING USED. THE INSTRUMENT DID NOT GRASP THE TISSUE. THE SURGEON BELIEVED THAT MANUFACTURING WAS THE CAUSE OF THE ISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD MATERIAL. THE SURGEON USED A LAPAROSCOPIC FORCEPS TO RETRIEVE THE FRAGMENT. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT. UPON VISUAL INSPECTION, THE SURGEON CONFIRMED THAT THERE WAS NO REMAINING FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON STATED THAT NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT AND THE FRAGMENT WILL BE RETURNED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PREPARING FOR A CRANIAL CASE, TURN ROBOT ON, AND NOT GETTING PAST THE EXCELSIUS GPS HOME SCREEN. TRIED RESTARTING AND POWER CYCLING, UNPLUGGING FOR MULTIPLE MINUTES. HAVE NOT BEEN ABLE TO GET PAST IT.

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 ALL THE USERS PASSWORDS HAD EXPIRED AND THEY WERE UNABLE TO LOGIN TO THE MONARCH SYSTEM. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULED.

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TA LITERATURE ARTICLE WAS REVIEWED THAT DESCRIBED A COHORT STUDY OF 2225 PATIENTS THAT UNDERWENT ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY FROM JANUARY 2015 TO DECEMBER 2022. THE AIM OF THE STUDY WAS TO PROVIDE A COMPREHENSIVE DESCRIPTION OF PERIOPERATIVE MORBIDITY ASSOCIATED WITH RAS IN GYNECOLOGICAL ONCOLOGY TO ENHANCE PREOPERATIVE COUNSELING AND SUPPORT SHARED DECISION-MAKING. A GYNECOLOGICAL ONCOLOGIST PERFORMED THE SURGERY IN 98% OF THE CASES, AND 64% OF THESE SURGEONS WERE ALREADY EXPERIENCED IN RAS (>50 ROBOTIC PROCEDURES). THE DA VINCI SI SYSTEM WAS USED IN 524 CASES AND THE DA VINCI XI SYSTEM IN 1701 CASES. THE STUDY REPORTED 64 INTRAOPERATIVE COMPLICATIONS, WITH BOWEL INJURIES BEING THE MOST COMMON. TWO PATIENTS EXPERIENCED TROCAR LESIONS OF THE COLON REQUIRING CONVERSION TO LAPAROTOMY, WHILE THE OTHER BOWEL LESIONS (TYPICALLY SEROSAL TEARS OR THERMAL LESIONS) WERE HANDLED BY ROBOT-ASSISTED SUTURING. VASCULAR COMPLICATIONS OCCURRED IN 16 PATIENTS, INCLUDING ONE BLUNT LESION OF THE ABDOMINAL AORTA DURING ENTRY WITH A BLUNT-TIP TROCAR IN A VERY SLIM PATIENT, AND 1 LESION OF THE RIGHT EXTERNAL ILIAC VEIN FOLLOWING LYMPHADENECTOMY AFTER PELVIC IRRADIATION. BOTH C

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE THAT DESCRIBED A COHORT STUDY OF 2225 PATIENTS THAT UNDERWENT ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY FROM JANUARY 2015 TO DECEMBER 2022. THE AIM OF THE STUDY WAS TO PROVIDE A COMPREHENSIVE DESCRIPTION OF PERIOPERATIVE MORBIDITY ASSOCIATED WITH ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY TO ENHANCE PREOPERATIVE COUNSELING AND SUPPORT SHARED DECISION-MAKING. A GYNECOLOGICAL ONCOLOGIST PERFORMED THE SURGERY IN 98% OF THE CASES, AND 64% OF THESE SURGEONS WERE ALREADY EXPERIENCED IN RAS (>50 ROBOTIC PROCEDURES). THE DA VINCI SI SYSTEM WAS USED IN 524 CASES AND THE DA VINCI XI SYSTEM IN 1701 CASES. AMONG THE 2225 PATIENTS, THE ARTICLE NOTED THAT ONE PATIENT DIED DUE TO CARDIOGENIC SHOCK 2 WEEKS AFTER UNCOMPLICATED RAS, THE CAUSE OF DEATH WAS FOUND TO BE MAJOR THROMBOEMBOLIC EVENT (TEE). THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENTS. THE STUDY CONCLUDED THAT RAS IN A HIGH-VOLUME GYNECOLOGICAL ONCOLOGY SETTING RESULTED IN LOW RATES OF MAJOR PERIOPERATIVE MORBIDITY AND CONVERSION TO LAPAROTOMY. THE FINDINGS SUPPORT THE USE OF RAS FOR SUITABLE PATIEN

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, THE HARMONIC ACE INSTRUMENT STOPPED WORKING. A PIECE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE INSTRUMENT FRAGMENT WAS RETRIEVED DURIGN THE SAME PROCEDURE WHICH WAS 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: A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY. A 6MM SKIN BURN WAS FOUND ON THE RIGHT BREAST WITH A SMALL BLISTER, DURING INTERNAL DISSECTION. THE BURN WAS TREATED WITH TOPICAL (BACITRACIN) TWICE DAILY. THERE WAS NO DEVICE MALFUNCTION OCCURRED THAT COULD HAVE CONTRIBUTED TO THE BURN AND THE SURGEON THOUGHT THE BURN WAS CAUSED BY DISSECTION TOO CLOSE TO THE DERMIS DURING INTERNAL DISSECTION.

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: DURING A DBS CASE SET UP A CAMERA HARDWARE MALFUNCTION, WARNING DISPLAYED ONCE THE CAMERA WAS PLUGGED IN. THE JAR ALARM INDICATOR LIGHT WAS ALSO ILLUMINATED.

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 CT SCAN CONFIRMED.

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 CT SCAN SHOWS MULTIPLE MEDIAL BREACHES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY, THE ENTIRE TIP FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT THE ENTIRE PIECE WAS RETRIEVED AND ACCOUNTED FOR DURING THE SAME PROCEDURE. THE PROCEDURE WAS 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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIPS COVER ACCESSORIES FELL OFF THE INSTRUMENTS INSIDE THE PATIENT. THE SURGEON RETRIEVED THE MCS TIP COVER ACCESSORIES AND USED A MONOPOLAR CAUTERY INSTRUMENT WITH A HOOK TIP TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE MCS TIP COVER WAS RETRIEVED WITH A GRASPER. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE AND NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND MCS TIP COVER ACCESSORY. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE PROCEDURE WAS ROBOTICALLY COMPLETED. THE MCS TIP COVER ACCESSORY AND INSTRUMENT WERE NOT AVAILA