BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 2250830 · Received September 8, 2011

    Report

    Report Number
    2250830
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 29, 2011
    Report Date
    September 8, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHEN THE SURGEON CLAMPED DOWN ON THE TISSUE, THE STAPLER WOULD NOT OPEN BACK UP. THE STAPLER HAD TO BE MANUALLY RELEASED. THE STAPLER HANDPIECE AND INSERT WERE SENT TO BIOMED FOR EVALUATION.MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, ECHELON(PER SITE REPORTER): RETURN FOR ANALYSIS AND FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. EC60 H4466P

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR