BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23044123 · Received September 12, 2025

    Report

    Report Number
    2955842-2025-37773
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 12, 2025
    Report Date
    August 19, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT WAS ANALYZED AND FOUND TO THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE MONOPOLAR ENERGY CORD WAS CONNECTED TO AN IN-HOUSE ERBE GENERATOR AND PASSED RECOGNITION AS AN ENERGY DEVICE. THE INSTRUMENT PASSED ENERGY DELIVERY TESTING IN VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT ALSO PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. THE COMPLAINT REGARDING THE POWER IS NOT TRANSMITTED UP TO THE TIP, LEAK AT THE JOINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT (PCH) WOULD NOT DELIVER ENERGY, LEAK AT THE JOINT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180601 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-16 K10230310 0042 00886874112311

    Patients

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