BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23660509 · Received November 26, 2025

    Report

    Report Number
    2955842-2025-46150
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    July 18, 2025
    Report Date
    November 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYSTEM LOGS SHOW THAT THE VSE INSTRUMENT WAS INSTALLED 4 TIMES AND PASSED HOMING ALL 4 TIMES. THE FIRST TWO INSTALLS DID NOT HAVE ANY CUT OR SEAL EVENTS LOGGED. THE DATA LOGS SHOW 100 TOTAL SEAL EVENTS AND 68 TOTAL CUT COMPLETE EVENTS, NEARLY ALL OF WHICH OCCURRED ON THE THIRD INSTALL. THE FOURTH INSTALL HAD 1 SEAL EVENT FOLLOWED BY ONE JAW ANGLE OPEN EVENT, FOLLOWED BY ANOTHER SEAL EVENT, AND THE FINAL RECORDED EVENT WAS A CUT COMPLETE. THERE WERE NO ERRORS RELEVANT TO THE REPORTED COMPLAINT WAS SEEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY, THE CUSTOMER ENCOUNTERED DIFFICULTY SEALING TISSUE WITH A VESSEL SEALER EXTEND (VSE) INSTRUMENT. TISSUE WAS STICKING TO THE INSTRUMENT. IN ADDITION, THE CUSTOMER INDICATED THAT THE VSE INSTRUMENT FAILED TO ACHIEVE A COMPLETE SEAL AFTER MULTIPLE ATTEMPTS BY THE SURGEON. THERE WERE NO ERRORS RECORDED, AND EACH SEAL CYCLE COMPLETED WITH THE EXPECTED AUDIBLE CONFIRMATION TONES. THE TARGET TISSUE WAS LESS THAN 7 MILLIMETERS IN SIZE AND HAD NOT BEEN EXPOSED TO CHEMOTHERAPY OR RADIATION THERAPY. THE JAWS OF THE VSE INSTRUMENT DID NOT COME INTO CONTACT WITH ANY LIQUIDS, BIOLOGICAL DEBRIS, CLIPS, SUTURES, STAPLES, OR OTHER METALLIC OBJECTS. THE CUSTOMER INDICATED THAT THEY DID NOT CUT ANY TISSUE THAT WAS NOT FULLY SEALED; THEREFORE, THERE WAS NO INJURY SUSTAINED BY THE PATIENT. A BACKUP INSTRUMENT WAS USED AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148173 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 2402020366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES