BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 60-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3041965 · Received April 1, 2013

    Report

    Report Number
    2647580-2013-00184
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: DURING THE FIRST FIRING, THE FIRING KNOB BECAME QUITE STIFF AFTER IT CAME TO THE MIDDLE. THE KNOB COULD BE PUSHED FORWARD COMPLETELY AFTER THAT, BUT IT WAS TOO STIFF TO RETRACT AND FINALLY CAME OFF. THE SURGEON PUSHED THE RELEASE BUTTON TO PEN THE JAWS AND FOUND SOME DISTALLY FIRED STAPLES WERE NOT FORMED. AFTER REMOVING THE UNFORMED STAPLES, THE SURGEON SUTURED THE TISSUE. THE TISSUE WAS DAMAGED UPON REMOVING THE DEVICE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133038 GIA 60-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2J0049X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other