BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1151469 · Received September 5, 2008

    Report

    Report Number
    2647580-2008-00519
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: THE SURGEON HAD A STAPLE LINE BLEED DURING THE TRANSECTION OF THE BOWEL. HE HAD TO USE CAUTERY ON THE TISSUE TO STOP THE BLEEDING DURING HIS FUNCTIONAL END TO END ANASTAMOSIS. THE PT ALSO STARTED BLEEDING FROM THE ANASTAMOSIS POST-OPERATIVELY. A RE-OPERATION TO SUTURE THE STAPLE LINE AND BLOOD TRANSFUSION WERE PERFORMED TO STABILIZE THE STAPLE LINE. THE PT IS STABLE AND IS NOW HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER SURGICAL STAPLING DEVICE GDW PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R