BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 60-4.8 SINGLE USE LOADING UNIT

    MDR report key: 2980927 · Received February 19, 2013

    Report

    Report Number
    2647580-2013-00097
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 23, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: SUBTOTAL GASTRECTOMY. ACCORDING TO THE REPORTER: LEAKAGE OF THE CLOSED DUODENAL STUMP; LEAKAGE FOUND ON THE DRAINAGE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71338 TA 60-4.8 SINGLE USE LOADING UNIT DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P1A0175L

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other LOT #P2B0073X, MAN. 01/2011, EXP DATE 01/31/2016| TA 60-4.8 SINGLE USE RELOADABLE STAPLER: (B)(4)| K013860