BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3874045 · Received May 22, 2014

    Report

    Report Number
    3874045
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 22, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER FIRED ONCE INCORRECTLY AND THEN WOULD NOT FIRE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306184 EPIX UNIVERSAL CLIP APPLIER CLIP, IMPLANTABLE FZP APPLIED MEDICAL CA500 1211465

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR