BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP II

    MDR report key: 6166049 · Received December 12, 2016

    Report

    Report Number
    6166049
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 15, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CLIP APPLIER FIRED A COUPLE CLIPS CORRECTLY. THEN AFTER THAT IT WOULD EJECT THE CLIP BEFORE IT WAS CRIMPED. NEW CLIP APPLIER USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817461 ENDO CLIP II CLIP, IMPLANTABLE FZP COVIDIEN 176657

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR