BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1678027 · Received May 4, 2010

    Report

    Report Number
    MW5015827
    Event Type
    Injury
    Date Received
    May 4, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 4, 2010
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY, A ROTATING CLIP WAS ADVANCED AFTER BEING INTRODUCED INTO THE GASTROSCOPE. THE CLIP WAS BENT AND CLOSED AT TIME OF ADVANCEMENT; THEREFORE, IT WAS NOT ABLE TO DEPLOY AND FIX WHERE IT WAS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDO CLIPS GDO OLYMPUS AMERICA INC. 201UR-135 96K

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Disability