BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH

    MDR report key: 1212529 · Received October 23, 2008

    Report

    Report Number
    1212529
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    August 5, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE STAPLER FIRED STAPLES, BUT DID NOT CUT THE TISSUE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY * E4L938

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR