BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23307383 · Received October 16, 2025

    Report

    Report Number
    2955842-2025-41826
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 23, 2025
    Report Date
    September 23, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND THE REPORTED ISSUE OF LOOSE CABLE WAS CONFIRMED. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE PROBABLE ROOT CAUSE OF CABLE BREAKAGE, WHETHER PARTIAL OR FULL, IS ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS OBSERVED WITH LOOSE CABLES OFF TRACKS, RESULTING IN THE INABILITY TO PERFORM CLIP FUNCTION. THERE WAS NO DROP AND NO COLLISION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 13-OCT-2025: THE REPORTED ISSUE OCCURRED AFTER THE FIRST CLIP APPLICATION, WHEN LOADING THE NEXT CLIP, THE CABLE WAS OFF TRACK AND UNABLE TO HOLD NEXT CLIP. THE CLIP APPLIER INSTRUMENT WAS UNABLE TO USE ALL MOVEMENT SINCE CABLES WERE OFF. THE INSTRUMENT WAS ONLY USED ONCE AFTER THE FIRST CLIP APPLICATION. THE ISSUE WAS RESOLVED WITH USED OF ADDITIONAL CLIP APPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2743222 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K11240613 0035

    Patients

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