BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP 5MM CLIP APPLIER

    MDR report key: 1920517 · Received December 6, 2010

    Report

    Report Number
    1219930-2010-00924
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 10, 2010
    Manufacturer
    UNITED STATES SURGICAL
    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

    PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE DEVICE CUT THROUGH THE VESSELS INSTEAD OF CLIPPING; HEMORRHAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP 5MM CLIP APPLIER DISPOSABLE CLIP APPLIER FZP UNITED STATES SURGICAL N0G0484

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability