BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3911777 · Received July 1, 2014

    Report

    Report Number
    3911777
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 1, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLIP APPLIER WOULD NOT FIRE (ACTIVATE CLIPS). SURGEON ATTEMPTED SEVERAL TIMES WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381683 EPIX UNIVERSAL CLIP APPLIER CLIP, IMPLANTABLE FZP APPLIED MEDICAL * 1217602

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR