BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLIP

    MDR report key: 3924963 · Received July 3, 2014

    Report

    Report Number
    3924963
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 3, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHEN TRYING TO FIRE ENDOCLIP FOR THE FIRST TIME, THE CLIP RETRACTED BACK AND STUCK. THE ENDOCLIP WOULD NOT FIRE. ENDOCLIP WAS TAKEN OFF FIELD AND ANOTHER DEVICE OBTAINED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391954 ENDOCLIP CLIP, IMPLANTABLE FZP COVIDIEN LP 176630 N4E0009MX

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR