BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER

    MDR report key: 2062610 · Received April 8, 2011

    Report

    Report Number
    1219930-2011-00278
    Event Type
    Injury
    Date Received
    April 8, 2011
    Report Date
    March 21, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    FZP
    PMA / PMN Number
    K954435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING THE CASE, WHEN LOADING A CLIP, IT WOULD SHOOT AN EXTRA CLIP OUT. THE CLIPS FELL INTO THE PATIENT'S CAVITY AND ONE CLIP WAS NOT RETRIEVED AS IT COULD NOT BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP LRGE 10MM PISTOL GRIP APPLIER DISPOSABLE CLIP APPLIER FZP UNITED STATES SURGICAL N0K0449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other