BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SMALL CLIP APPLIER (DA VINCI)

    MDR report key: 3254025 · Received June 26, 2013

    Report

    Report Number
    3254025
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    WHEN SMALL CLIP APPLIER ENDOWRIST WAS BEING LOADED WITH THE SMALL CLIP, ONE OF THE TIPS ON THE ENDOWRIST BROKE. INSTRUMENT WAS NOT INSIDE OF THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ROBOTIC THYMECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289495 ENDOWRIST SMALL CLIP APPLIER (DA VINCI) SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *