BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1060926 · Received June 13, 2008

    Report

    Report Number
    2647580-2008-00348
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROTOMY. ACCORDING TO THE RPTR: AFTER THE SECOND FIRING OF THE DEVICE, THE STAPLE LINE DID NOT HOLD AND FELL APART. THE ENTIRE AREA WAS RESECTED AND THE ANASTOMOSIS WAS HAND SEWED. OR TIME WAS EXTENDED MORE THAN 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P8B0566

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention LOT# P8A0876| GIA 80-3.8 SINGLE USE LOADING UNIT CAT # GIA8038L