BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER

    MDR report key: 2644866 · Received June 28, 2012

    Report

    Report Number
    1219930-2012-00542
    Event Type
    Injury
    Date Received
    June 28, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 11, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    FZP
    PMA / PMN Number
    K954435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: AFTER BEING APPLIED, SIX CLIPS RE-OPENED. THE SURGEON CONVERTED IMMEDIATELY INTO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER DISPOSABLE CLIP APPLIER FZP COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other