BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD FOR ECHELON 60

    MDR report key: 1211890 · Received October 23, 2008

    Report

    Report Number
    3005075853-2008-02535
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, AFTER FIRING THEY OPENED THE DEVICE AND FOUND THAT THE STAPLES DID NOT CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD RELOAD FOR ECHELON 60 GDW ETHICON ENDO-SURGERY, LLC. NA E4K076

    Patients

    Seq Age Sex Outcome Treatment
    1