BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 2213806 · Received April 17, 2008

    Report

    Report Number
    MW5021735
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 8, 2008
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ATW 45 STAPLER WAS APPLIED AND FIRED. ONCE THE STAPLER WAS FIRED, THE CARTRIDGE EJECTED FROM THE STAPLER, WHICH WAS AN APPARENT MALFUNCTION. NECESSITATED OPEN THORACOTOMY AND PROLONGED HOSPITALIZATION. PT DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ETHICON STAPLER ATW45 GDW ATW45 D4JO3E

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| O| R