BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1242411 · Received November 24, 2008

    Report

    Report Number
    3005075853-2008-03328
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 18, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACIC PROCEDURE, THE DEVICE WAS CLAMPED ON TISSUE BUT IT WOULD NOT FIRE. THE DEVICE WOULD NOT RELEASE FROM THE TISSUE AND HAD TO BE CUT OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE IS BEING HELD BY RISK MANAGEMENT AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1