BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON STAPLER

    MDR report key: 1212093 · Received September 10, 2008

    Report

    Report Number
    1212093
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 2, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    STAPLE FAILURE DURING GASTRIC BYPASS SURGERY. STAPLE LINE MALFORMATION. NEW STAPLING INSTRUMENT OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON STAPLER STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC * E4KM1M

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR