BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST FENESTRATED BIPOLAR FORCEPS

    MDR report key: 18835994 · Received March 5, 2024

    Report

    Report Number
    18835994
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 19, 2024
    Report Date
    February 20, 2024
    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

    SURGEON HAD BEEN OPERATING APPROX. 2.5 HRS WHEN THE FENESTRATED BIPOLAR FORCEPS MALFUNCTIONED. A CABLE BROKE. CASE WAS FINISHED WITH A DIFFERENT INSTRUMENT FROM SAME SET. ID FOR MALFUNCTIONING FORCEPS IS K11-23091-0437, IT WAS FROM DAVINCI SET # 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138960 ENDOWRIST FENESTRATED BIPOLAR FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 471205 K1123091-0437

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female