BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLIP

    MDR report key: 3861259 · Received April 25, 2014

    Report

    Report Number
    3861259
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR APPLIED FOUR CLIPS WHEN THE DEVICE STOPPED WORKING. ANOTHER APPLIER WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250965 ENDOCLIP APPLIER, SURGICAL, CLIP GDO COVIDIEN * N3E0115X

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR