BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1202063 · Received October 10, 2008

    Report

    Report Number
    MW5008611
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 10, 2008
    Manufacturer
    GYRUS ACMI
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLIP WAS DIFFICULT TO PUSH OUT OF THIS SHEATH SCOPE WHICH WAS NOT TORQUED. WHEN THE CLIP CAME OUT, IT WAS AT AN ANGLE. IT DID NOT OPEN OR DEPLOY CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS QUICK CLIP GCJ GYRUS ACMI 82 K

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR