BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 100-4.8 SINGLE USE RELOADABLE

    MDR report key: 3902305 · Received June 25, 2014

    Report

    Report Number
    2647580-2014-00476
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: WHIPPLE. ACCORDING TO THE REPORTER: AFTER THE STOMACH WAS TRANSECTED, THE STAPLE LINE CAME APART. ANOTHER RELOAD OF THE SAME KIND WAS APPLIED WITH THE SAME RESULT. THE ORIGINAL STAPLE LINE WAS RESECTED WITH THE 2ND APPLICATION OF THE STAPLER. THE SURGEON OVER SEWED MALFORMED STAPLE LINE. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500 CC. THERE WAS DELAY OVER 30 MINUTES. NO DEVICE FRAGMENT FELL IN THE PT CAVITY. NO DEVICE FRAGMENT WAS LEFT IN THE PT. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370597 GIA 100-4.8 SINGLE USE RELOADABLE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P3L0290X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GIA 100-4.8 SINGLE USE LOADING UNIT, GIA 10048L,| LOT #: P4A0193X, EXP: 01/31/2019, MFG: 01/2014