BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21636578 · Received March 18, 2025

    Report

    Report Number
    2955842-2025-09412
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    January 28, 2025
    Report Date
    February 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119778
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED GRIP CABLE.

    Description of Event or Problem · 0

    ON 01/28/2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: HI, WE HAD TO GET A NEW CADIERE FORCEPS FOR THE ROBOT. THERE ARE WIRES STICKING OUT OF THE INSTRUMENT. WE REMOVED THE CADIERE FORCEPS AND REPLACED WITH A NEW ONE. WE ALSO HAD TO GET A NEW DA VINCI CAUTERY HOOK AND REPLACED THAT TO THE FIELD. BOTH WERE USED IN THE PATIENT BEFORE GETTING A NEW INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453363 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-08 K10240822 0394 00886874119778

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.