BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20565824 · Received October 30, 2024

    Report

    Report Number
    20565824
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 14, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    WHEN INSTRUMENT WAS DOCKED AND INSIDE OF PATIENT, SURGEON NOTICED THE JAWS WERE MISALIGNED WHEN ATTEMPTING USE. NEW INSTRUMENT USED. NO PATIENT HARM. INCIDENT HAS BEEN REPORTED TO INTUITIVE & RETURNED. RGA#. MANUFACTURER RESPONSE FOR ROBOTIC FENESRTATEDGRASPER, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA#

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965705 ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 470347

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Unknown