Zodiac FreeRider FR1000 iQ robotic pool cleaner — Manufacturing defect creates weak points in the battery enclosure, which may allow water to leak into the battery and cause overheating, risking serious injury or property damage from fire. No injuries/incidents specified. Affected serial numbers begin ACLA03133 with specific four-digit suffixes. Consumers told to discontinue use/charging, separate from docking station, and contact Fluidra for free pickup and replacement.

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.

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 APPROXIMATELY A MONTH AGO A PATIENT WAS PUT UNDER ANESTHESIA AND HAD BONE FIDUCIALS PUT IN WHEN THE CASE HAD TO BE ABORTED DUE TO A DRIFTING ARM AND BEING UNABLE TO CALIBRATE THE TOOLS. THE SURGERY WAS COMPLETED TWO DAYS LATER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT WOULD NOT TURN ON AT (B)(6). WE ASSUME A FUSE HAS BLOWN.

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 EXCELSUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE MISPLACED SCREWS CAUSE A LACK OF MOTION AND SENSATION FOR THE LEFT LEG SINCE THE SPINAL CORD WAS INJURED BY THE MISPLACED SCREWS. THE REPRESENTATIVE SPOKE WITH THE SURGEON ON AUGUST 14TH, AND ACCORDING TO THE SURGEON, THE CONDITION OF THE PATIENT GOT SLIGHTLY BETTER TILL THAT DAY AS HE GOT BACK SOME SENSATION AND MOTION BUT IS STILL FAR AWAY FROM BEING ABLE TO WALK NORMAL.

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 AFTER A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN EXPANDING RIGHT BREAST HEMATOMA AND REQUIRED RE-OPERATION THE SAME DAY. THE RE-OPERATION INCLUDED A RIGHT BREAST RE-EXPLORATION, WASHOUT, AND TISSUE EXPANDER IMPLANT PLACEMENT AND UPSIZE. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY ONE WITHOUT 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.

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: IT WAS REPORTED THAT A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY, RECEIVED AN INTRA-OPERATIVE "INDIRECT" THERMAL INJURY FROM USING THE BIPOLAR CAUTERY IN THE BREAST ENVELOPE TRANSMITTING HEAT ACROSS THE DERMIS TO THE EPIDERMIS. TWO AREAS IN LATERAL LEFT BREAST WITH DESQUAMATION SECONDARY TO BIPOLAR CAUTERY WERE USED DURING SKIN FLAP DISSECTION. THE BEDSIDE ASSIST NOTED WARMTH ON THE FLAP AND BIPOLAR STOPPED FOR 1 OF 2 LESIONS. ONE 0.8 CM DIAMETER AND ONE 0.2 CM DIAMETER. ANTIBIOTIC OINTMENT WAS USED ON THE DAY OF SURGERY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND CAME BACK FOR A 14-DAY VISIT WITH NO OTHER REPORTABLE ISSUES. THERE WAS NO DEVICE MALFUNCTION.

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 CLINICAL STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE WITH IMMEDIATE NON-ROBOTIC RECONSTRUCTION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WAS NO DEVICE MALFUNCTIONS REPORTED DURING THE PROCEDURE. THREE WEEKS LATER, THE PATIENT SHOWED SIGNS OF CELLULITIS AND ANTIBIOTICS WERE GIVEN. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) FIVE DAYS LATER WITH WORSENING OF SYMPTOMS, WAS GIVEN IV ANTIBIOTICS, AND WAS DISCHARGED THE SAME WITH ORAL ANTIBIOTICS (ZYVOX). THE NEXT DAY, THE CELLULITIS PROGRESSED TO AN ABSCESS AND THE PATIENT WAS HOSPITALIZED FOR IMPLANT REMOVAL AND WASHOUT ABSCESS.

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 IN A STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) SURGICAL PROCEDURE. BILATERAL INCISIONS WERE EXTENDED TO REMOVE THE SPECIMEN. BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE NSM AND RECONSTRUCTION PROCEDURES. A ONE STAGE RECONSTRUCTION WAS PERFORMED AND BILATERAL DRAINS WERE PLACED (REMOVED 12 DAYS LATER). THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WERE NO INTRA-OPERATIVE ADVERSE EVENTS AND NO DA VINCI DEVICE MALFUNCTIONS DURING THE PROCEDURE. A RETURN TO THE OPERATING ROOM FOR REMOVAL OF ANTIBIOTIC BEADS AND REPLACEMENT OF IMPLANT OCCURRED SEVEN MONTHS LATER. DURING A FOLLOW-UP VISIT THE NEXT MONTH, A RIGHT BREAST SEROMA WAS REPORTED; A PALPABLE FLUID COLLECTION ON THE RIGHT RECONSTRUCTED BREAST WAS NOTED. A RADIOLOGY VISIT WAS ORDERED FOR EVALUATION AND ASPIRATION; 142 CC OF SEROMA WERE ASPIRATED FROM THE RIGHT BREAST POCKET. NO SEQUELAE WERE NOTED. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT (SAE), A CLAVIEN-DINDO GRADE III, NOT RELATED TO THE DA VINCI STUDY DEVICE, NOT RELATED TO THE NSM PROCEDURE, NOT RELATED TO THE RECONSTRUCTION PROCEDURE.

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, SCREW WAS MISPLACED DURING A PROCEDURE WITH EGPS. THE SURGEON FOUND OUT VIA INTRA-OPERATIVE CT WHEN SWITCHING SYSTEMS TO STEALTH NAVIGATION. HAVING STRUGGLED TO OBTAIN GREEN BOARDER TRAJECTORIES FOR THE FIRST TWO SCREWS USING EGPS, A LANDMARK CHECK WAS CARRIED OUT AND IT WAS DISCOVERED THAT THE REGISTRATION WAS NOT ACCURATE. IT WAS AT THIS POINT THAT THE SURGEON REQUESTED TO CEASE USING EGPS AND TO OBTAIN ANOTHER O-ARM SPIN AND PROCEED WITH STEALTH NAVIGATION. CASE WAS AN MIS TUMOR STABILIZATION FOR L3 TUMOR. THE PLAN WAS TO INSTRUMENT L1,L2, L4 AND L5.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY PROCEDURE, THE IMAGE OF THE SURGICAL FIELD FROZE TWICE WHILE THE SURGEON WAS DISSECTING THE ILIAC ARTERY, CAUSING AN INJURY AND BLEEDING. THE 0 DEGREE ENDOSCOPE PLUS WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY IDENTIFIED. WHEN THE IMAGE FROZE FOR APPROXIMATELY 1 MINUTE, THE SYSTEM WAS STILL DISPLAYING THE SURGICAL FIELD, BUT THE IMAGE DID NOT REACT TO THE MOVEMENT INITIATED BY THE SURGEON. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BEING USED TO DISSECT THE ILIAC ARTERY WHEN THE LOSS OF THE IMAGE OCCURRED; CAUSING THE MCS INSTRUMENT TO INJURE THE ARTERY AND BLEEDING OCCURRED. THE BLEEDING WAS UNEXPECTED, AND THE BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 400ML. TO RESOLVE THE BLEEDING, THE HOLE ON THE ARTERY WAS SUTURED CLOSED; THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO HELP TROUBLESHOOT THE ISSUE, AND UPON REVIEWING THE LOGS, A RECURRENT ERROR INDICATING AN ISSUE WITH THE 0 DEGREE ENDOSCOPE PLUS WAS OBSERVED. THE CUSTOMER INFORMED THE TSE THAT A SPARE 0 DEGRE

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MED/POST HAPTICS WERE SO LARGE THAT IT ALLOWED SAW BLADE TO CUT SUPERFICIAL FIBERS OF THE MCL. PRODUCT MANAGEMENT HAVE BEEN MADE AWARE AND ARE SUBMITTING THIS CASE TO ENGINEERS IN US FOR AN EXPLANATION. ALL CASE DETAILS HAVE BEEN FORWARDED TO FSE TEAM REQUIRED LIGAMENT REPAIR AND TS POLY.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP COVER ACCESSORY WAS POSSIBLY LEFT IN THE PATIENT. THE CUSTOMER BELIEVED THE MCS TIP COVER ACCESSORY FELL OFF INTO THE PATIENT. THE CUSTOMER WAS NOT ABLE TO LOCATE IT INSIDE OR OUTSIDE THE PATIENT. THE CUSTOMER DID AN X-RAYS TO SEE IF THEY COULD FIND IT IN THE PATIENT. 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 A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

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 ROBOT WAS SLIDING DURING CASE. SUBSEQUENTLY THE CASE HAD TO BE CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA AND INCISION MADE. THE PATIENT HAD TO GO BACK UNDER ANESTHESIA FOUR DAYS LATER, WHEN THE CASE WAS COMPLETED. THE SURGEON DID REPORT BACK TO THE REP THREE DAYS AFTER THE COMPLETED CASE THAT THE PATIENT WAS DOING WELL. NO FURTHER INFORMATION KNOWN.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS A CRANIAL DBS PROCEDURE ON GMED 4.0. USER PLACED DBS ELECTRODE WITH TOP TO TARGET SET AT 192MM. THE LEAD WAS TOO SHALLOW AND BASED OFF MICRO-ELECTRODE RECORDINGS. THE LEAD WAS REPLACED W/ THE TOP TO TARGET AT THE CORRECT DEPTH. NO FURTHER ISSUES ENCOUNTERED AND CASE WAS COMPLETED AS NORMAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM. THIS EVENT OCCURRED IN GERMANY.

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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON REPORTED AN INJURY TO THE POPLITEUS TENDON AFTER OSTEOTOMY WITH MAKO. THE TIMING OF THE INJURY IS UNKNOWN.

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. THE REST OF THE SURGERY WAS PERFORMED FREEHAND.

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 RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT REQUIRED A SUBSEQUENT PROCEDURE DUE TO BLEEDING. THE SURGEON INITIALLY UTILIZED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WITH AN E-100 GENERATOR. IT WAS REPORTED THAT THE E-100 GENERATOR KEPT FAULTING WITH A MESSAGE TO CHECK THE CABLE CONNECTIONS. THE CUSTOMER ALSO REPORTED BLEEDING DUE TO INTERMITTENT ENERGY FROM THE E-100 GENERATOR. THE CUSTOMER CHANGED OUT THE VSE INSTRUMENT AND POWER CYCLED THE E-100 GENERATOR BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER THEN SWITCHED TO AN ERBE GENERATOR FOR THE REMAINDER OF THE PROCEDURE, SPECIFICALLY ON VESSELS WITHIN THE MESENTERY AND ALONG THE ILEUM. IT WAS NOTED THROUGHOUT THE PROCEDURE, THE VSE INSTRUMENT MADE THE PROPER SEALING TONES AND NO ERROR MESSAGES WERE PRODUCED. HOWEVER, THE SURGEON STATED THE SEALING TIME TOOK LONGER THAN NORMAL ON MOST SEALING ATTEMPTS. ONCE THE SEALING WAS COMPLETE, THE VESSELS LOOKED FULLY SEALED AND NO ADDITIONAL BLEEDING OCCURRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO COMPLICATIONS AND THE PATIENT WAS NOTED TO BE "DRY." WITHIN FIFTEEN MINUTES IN THE POST ANESTHESIA CARE UNIT (PACU) THE PATIENT BECAME HYPOT

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 INSTRUMENT WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT EXHIBITED AN ENERGY OUTPUT ISSUE. THE CUSTOMER REPORTED THAT A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED USING A PROGRASP FORCEPS INSTRUMENT DURING THE SAME PROCEDURE. THE CUSTOMER VISUALLY CONFIRMED THE BROKEN PART MATCHING THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.

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 THAT AN INSTRUMENT BROKE IN THE PATIENT. THE CUSTOMER INQUIRED IF THE WIRES AND SHAFT OF THE INSTRUMENT COULD BE DETECTED BY X-RAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DESPITE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL DETAILS, THE SPECIFIC TYPE OF INSTRUMENT THAT WAS USED REMAINS UNKNOWN.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NILSSEN, P. K., NARENDRAN, N., SKAGGS, D. L., TUCHMAN, A., WALKER, C. T., & PERRY, T. G. (2024). COMPARISON OF ROSTRAL FACET JOINT VIOLATIONS IN ROBOTIC- AND NAVIGATION-ASSISTED PEDICLE SCREW PLACEMENT FOR ADULT LUMBAR SPINE INSTRUMENTATION. THE SPINE JOURNAL. HTTPS://DOI.ORG/10.1016/J.SPINEE.2024.07.008 SUMMARY: BACKGROUND CONTEXT: FACET JOINT VIOLATION BY PEDICLE SCREWS MAY LEAD TO ADJACENT-SEGMENT DISEASE AND POSTOPERATIVE PAIN. PREVIOUS STUDIES HAVE REPORTED THE INCIDENCE OF ROSTRAL FACET JOINT VIOLATION USING VARIOUS PEDICLE SCREW INSERTION TECHNIQUES. HOWEVER, THE INCIDENCE OF FACET JOINT VIOLATIONS WITH ROBOTIC GUIDANCE HAS NOT BEEN DETERMINED. PURPOSE: TO INVESTIGATE AND COMPARE THE INCIDENCE OF ROSTRAL FACET JOINT VIOLATION BY PEDICLE SCREWS UNDER ROBOTIC GUIDANCE AND COMPUTERIZED TOMOGRAPHY (CT) NAVIGATION GUIDANCE. STUDY DESIGN/SETTING: RETROSPECTIVE MATCHED COHORT. PATIENT SAMPLE: ALL PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED LUMBAR FUSION AT A MAJOR SPINE CENTER UP UNTIL 2023 WERE RETROSPECTIVELY IDENTIFIED AND MATCHED 1:3 TO PATIENTS UNDERGOING CT NAVIGATION GUIDANCE BASED BY ON AGE, SEX, ROSTRAL VERTEBRAL LEVEL, AND LENGTH OF CONSTRUCT. INCLUSION CRITERIA CONSISTED OF

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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT. THE MCS INSTRUMENT HAD REPORTEDLY BECOME STUCK AT A RIGHT ANGLE. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING 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: 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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT ONE OF THE UNIVERSAL SEAL ACCESSORIES BEING UTILIZED HAD A TRIANGLE PIECE BREAK OFF THE GASKET AND FALL INTO THE PATIENT ANATOMY. THE PERFORMING SURGEON HAPPENED TO NOTICE THE FRAGMENT AND IT WAS SUBSEQUENTLY RETRIEVED AND PULLED OUT. AFTER COMPLETION OF THE PROCEDURE, THE STAFF CHECKED THE SEAL AND DISCOVERED THAT IT HAD A HOLE IN IT. NO FURTHER COMPLICATIONS OR ISSUES WERE NOTED FOLLOWING THE INCIDENT. THE CSR ADVISED THAT THE STAFF WOULD BE INFORMED TO RETAIN THE UNIVERSAL SEAL ACCESSORY FOR FURTHER RETURN AND EVALUATION. 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 INITIAL REPORTER SAID THAT THE SEAL WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED. THE SURGICAL TASK THAT WAS BEING PERFORMED WHEN THE SEAL FRAGMENT FELL INSIDE THE PATIENT WAS INSTRUMENT REMOVAL. IT IS UNKNOWN WHAT CAUSED THE SEAL TO BREAK OR CAUSED THE FRAGME

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; THE ROBOT WAS ABLE TO CALIBRATE THE EMPTY ARM BUT FAILED TO CALIBRATE THE POINTER PROBE. RECALIBRATION EMPTY WAS PERFORMED SUCCESSFULLY AND THEN POINTER PROBE CALIBRATED SUCCESSFULLY. ARM WAS THEN DRIVEN TOWARDS FIDUCIALS. ARM BEGAN TO DRIFT IN FAST MODE WITH NO MANUAL INPUT. FULL POWER DOWN WAS PERFORMED AND ISSUED PERSISTS. PROCEDURE WAS ABORTED AFTER IMPLANTATION OF BONE FIDUCIALS THAT WOULD REQUIRE CLOSURE.

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 AMONG 30 DA VINCI ASSISTED SINGLE PORT NIPPLE SPARING MASTECTOMIES THAT WAS A PART OF A CLINICAL STUDY, 8 PATIENTS WERE FOUND WITH THERMAL BLISTERS NEAR THE MEDIAL BREAST AREA. THE PHYSICIAN STATED THERE'S NO IMPACT ON THE PATIENT OTHER THAN COSMESIS THAT THERE WILL BE SCARS UPON HEALING. THE PROCEDURES WERE COMPLETED AS PLANNED WITHOUT DEVICE MALFUNCTION OCCURRED. THE PHYSICIAN THOUGHT THE CAUSE OF THE BLISTERS MAY BE DUE TO THE TISSUE TENSION APPLIED NEAR THE SKIN DUE TO THE NUMBER OF RETRACTION INSTRUMENTS. THE PHYSICIAN USES TWO INSTRUMENTS FOR RETRACTION IN SINGLE PORT SURGERIES, WHERE SHE USES THREE INSTRUMENTS IN MULTI-PORT SURGERIES.

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 (RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT A WASHER APPROXIMATELY 5 MILLIMETERS WAS FOUND INSIDE THE PATIENT¿S ANATOMY. THE SURGEON WAS ABLE TO REMOVE THE WASHER FROM THE BODY. THE CUSTOMER STATED THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1, 30-DEGREE ENDOSCOPE WAS INSTALLED ON USM 2, LARGE NEEDLE DRIVER (LND) WAS INSTALLED ON USM 3, AND SYNCHROSEAL INSTRUMENT WAS INSTALLED ON USM 4. THE CUSTOMER REVIEWED THE VIDEO RECORD AND CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT CAUSING A WASHER DETACHMENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS REMOVED USING A LAPAROSCOPIC INSTRUMENT. THE CUSTOMER REVIEWED THE VIDEO RECORD AND CONFIRMED THAT ALL FRAGMENT WAS REMOVED, AND ONLY THE WASHER FELL INTO THE PATIENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TEST WAS PERFORMED. THE NU

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 DUE TO MERGING ISSUE.

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 WASHER CAME LOOSE AND FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

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.

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 DUE TO ISSUES WITH MERGING.

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 CHOLECYSTECTOMY SURGICAL PROCEDURE THE EDGES OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT UNIFORM. IT WAS NOT FITTING PROPERLY TO THE MCS INSTRUMENT. THE CUSTOMER STATED THIS IS A DISPOSABLE ACCESSORY AND CANNOT BE RETURNED. THE HOSPITAL HAS DISCARDED THE ACCESSORY. INTUITIVE SURGICAL, INC. FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY HAD NON-UNIFORM EDGES AS VALIDATED BY THE OPERATING ROOM (OR) TEAM ONCE IT WAS OPEN FROM THE PACK. THE MCS TIP COVER ACCESSORY ALSO DID NOT FIT PROPERLY TO THE MCS, AND THE ORANGE BAND WAS PARTLY VISIBLE. THE TEAM DECIDED TO GO FORWARD WITH THE SAME MCS TIP COVER ASSUMING IT WOULD NOT DETACH FROM THE MCS. HOWEVER, THE SURGEON AND THE OR TEAM WERE QUICK TO VISUALIZE THE IMPROPER ATTACHMENT OF THE MSC TIP COVER ACCESSORY AND CHANGED IT ONCE THE DAMAGE WAS VISUALIZED AND CONFIRMED. THE DAMAGED MCS TIP COVER ACCESSORY DID FALL DURING THE SURGERY, BUT THE SURGICAL TEAM WAS VIGILANT ENOUGH TO IDENTIFY THE IMPROPER ATTACHMENT DUE TO A DEFECT IN THE MCS TIP COVER ACCESSORY. THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING A LAPA

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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TONG, M., ZHANG, S., ZHANG, W., MOU, L., DONG, Z., WANG, R., LI, S., <(>&<)> HUANG, Y. (2024). EFFICACY AND SAFETY OF NAVIGATION ROB OT-ASSISTED VERSUS CONVENTIONAL OBLIQUE LATERAL LUMBAR INTERBODY FUSION WITH INTERNAL FIXATION IN THE TREATMENT OF LUMBAR DEGENERATIVE DISEASES: A RETROSPECTIVE STUDY. MEDICINE, 103(32). HTTPS://DOI.ORG/10.1097/MD.0000000000039261 SUMMARY: EFFECTIVE INTERNAL FIXATION WITH PEDICLE SCREW IS A KEY FACTOR IN THE SUCCESS OF LUMBAR FUSION WITH INTERNAL FIXATION. WHETHER NAVIGATION ROBOTS CAN IMPROVE THE EFFICACY AND SAFETY OF SCREW PLACEMENT IS CONTROVERSIAL. THIRTY-EIGHT PATIENTS WHO UNDERWENT OBLIQUE LATERAL LUMBAR INTERBODY FUSION INTERNAL FIXATION FROM MARCH 2022 TO MAY 2023 WERE RETROSPECTIVELY ANALYZED, 16 CASES IN THE NAVIGATIONAL ROBOT GROUP AND 22 CASES IN THE FLUOROSCOPY GROUP. USING VISUAL ANALOG SCORE (VAS) FOR THE LOW BACK AND LOWER LIMBS, OSWESTRY DISABILITY INDEX TO COMPARE THE CLINICAL EFFICACY OF THE 2 GROUPS; USING PERIOPERATIVE INDEXES SUCH AS THE DURATION OF SURGERY, INTRAOPERATIVE BLOOD LOSS, INTRAOPERATIVE FLUOROSCOPY TIMES, AND POSTOPERATIVE HOSPITAL STAY TO COMPARE THE SAFETY OF THE 2 GROUPS; AND USING ACCURACY OF PEDICLE SCREWS (APS

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.

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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER STATED THAT A PIECE OF SYNCHROSEAL INSTRUMENT BROKE OFF AND HAD FALLEN OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE/REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE BY THE NURSE. WHEN REMOVED FROM THE OUTER PACKAGING (BLISTER PACK) THERE WAS NO VISIBLE DAMAGE. THE INSTRUMENT WAS INSERTED AT THE BEGINNING OF THE PROCEDURE. AFTER 2-3 MOVEMENTS AND GRIPPING OF TISSUE, ONE OF THE COVERS OF A FALLOW CAME OFF AND FELL INTO THE PATIENT'S BODY. THE SURGEON THINKS THE REASON FOR THE FRAGMENT FALLING ISSUE IS THAT THE GRASPING OF TISSUE HAD LOOSENED THE TOP PART - NO PARTICULAR MECHANICAL DAMAGE. THE INSTRUMENT WAS IN USE PRIOR TO THE ISSUE FOR 2 TO 3 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT FELL INSID

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. THE AMOUNT OF DEVIATION WAS UNKNOWN BY THE SITE.

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 DURING DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, WHEN DISSECTING THROUGH THE ROUND LIGAMENT ON THE RIGHT SIDE OF THE UTERUS THERE WAS AN AUDIBLE SNAP/CRACK OF THE HARMONIC ACE INSTRUMENT. WHEN THE SURGEON PULLED THE INSTRUMENT BACK TO INVESTIGATE, THEY NOTICED THAT THE MOBILE BLADE OF THE INSTRUMENT WAS NO LONGER ATTACHED. THE BLADE WAS LOCATED IN THE PATIENT'S PELVIS, UNDER THE UTERUS AND REMOVED UNDER DIRECT VISION BY THE ASSISTING SURGEON AT BEDSIDE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE TECHNICIAN THAT RECEIVED THE HARMONIC ONTO THE FIELD DID NOT NOTICE ANY DAMAGE TO THE INSTRUMENT. THE ISSUE WAS IDENTIFIED DURING ROBOTIC-ASSISTED HYSTERECTOMY, WHILE THE SURGEON WAS DISSECTING THE RIGHT SIDE OF THE UTERUS. PER THE SURGEON, THE ISSUE WAS CAUSED DUE TO A MANUFACTURING ERROR. THE REPORTER EXPLAINED TO THE SURGICAL STAFF THAT HARMONIC DOES NOT HAVE A WRIST. SNAPPING THE WORKING JAW OF THE HARMONIC BY APPLYING TOO MUCH PRESSURE WHILE TRYING TO TWIST THE INSTRUMENT AT THE SAME TIME WILL RESUL