BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3131376 · Received May 13, 2013

    Report

    Report Number
    2647580-2013-00257
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE GIA STAPLER WAS POSITIONED ACROSS THE TISSUE AND LOCKED PART WAY THROUGH THE FIRING. THE FIRING KNOB WAS FORCED TO THE DISTAL POSITION. THE STAPLER DID NOT TRANSECT THIS REMAINING TISSUE AND THE ENTIRE STAPLER MOVED AT THIS POINT AND TORE TISSUE. THE STAPLE LINE WAS NOT INTACT AND THE STAPLER HAS TO RE-RESECT. THERE WAS 2-3 CM OF UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. NOTHING FELL IN THE SURGICAL CAVITY. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO IRREVERSIBLE DAMAGE TO THE PT. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE. THE LOT NUMBER IS UNAVAILABLE AND THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211669 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other