BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21713454 · Received March 27, 2025

    Report

    Report Number
    2955842-2025-11776
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 28, 2025
    Report Date
    February 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM FORCE BIPOLAR INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE ONE BENT GRIP AT THE BASE OF THE GRIP. NO BROKEN COMPONENTS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE 8MM FORCE BIPOLAR INSTRUMENT WAS WORKING FINE THROUGH CASE. SURGEON OPENED THE JAWS TO GRASP TISSUE, AND IT LOOKED LIKE THE JOINT SLIPPED OUT. IT WAS NOT GIVING FULL MOVEMENT. CABLES LOOKED TO BE INTACT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432412 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10241017 0447 00886874120767

    Patients

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