BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIFIRE ENDO GIA 30-3.5 12MM STAPLER

    MDR report key: 1780779 · Received July 27, 2010

    Report

    Report Number
    2647580-2010-00654
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: ON THE SECOND FIRING THE JAWS DID NOT OPEN. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE IN ORDER TO FREE THE DEVICE FROM THE TISSUE. OPERATIVE TIME EXTENSION WAS REPORTED AS "COUPLE OF HOURS". THE PT REMAINED HOSPITALIZED FOR 1 TO 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE ENDO GIA 30-3.5 12MM STAPLER DISPOSABLE STAPLER GDW USSC PUERTO RICO P0A0545

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| O