BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1210054 · Received October 22, 2008

    Report

    Report Number
    3005075853-2008-02507
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 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
    MO, US
    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 THE DEVICE WAS USED DURING A GASTRIC BYPASS. DURING THE LAST FIRING AT THE ANGLE OF HIS, THE KNIFE PUSHED THE TISSUE OUT AND DID NOT CUT. THE STAPLES WERE MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, LLC NA E4KR7N

    Patients

    Seq Age Sex Outcome Treatment
    1