BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST CADIERE FORCEPS

    MDR report key: 21251448 · Received January 28, 2025

    Report

    Report Number
    21251448
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 27, 2025
    Report Date
    January 27, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HI, WE HAD TO GET A NEW CADIERE FORCEP FOR THE ROBOT. THERE ARE WIRES STICKING OUT OF THE INSTRUMENT. WE REMOVED THE CADIERE FORCEP 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
    2405414 ENDOWRIST CADIERE FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 471049 K10240822 0394

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female