BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1230505 · Received November 10, 2008

    Report

    Report Number
    3005075853-2008-02896
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY, THE JAW OF THE DEVICE WAS UNABLE TO REOPEN AFTER THE FIRING STROKE WAS COMPLETED. THE SURGEON TRIED THE MANUAL RELEASE TRIGGER WITHOUT SUCCESS. THE KNIFE OF THE INSTRUMENT WAS UNABLE TO RETRACK COMPLETELY INSIDE THE DEVICE SHAFT. A NEW DEVICE WAS OPENED AND POSITIONED SIDE TO SIDE FROM THE MALFUNCTIONING DEVICE TO COMPLETE THE TRANSECTION AND REMOVE THE DEFECTIVE DEVICE. THE INSTRUMENT DID FIRE AND ALL STAPLES WERE FORMED. DELAYED PROCEDURE BY 15 MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, LLC. NA E4LJ79

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention