BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON 45 ENDOPATH STAPLER

    MDR report key: 1221466 · Received November 5, 2008

    Report

    Report Number
    3005075853-2008-02845
    Event Type
    Death
    Date Received
    November 5, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 22, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED IN VATS UPPER LEFT LOBECTOMY. THE DEVICE WAS FIRED SIX TIMES PRIOR TO BEING FIRED ON THE PULMONARY ARTERY. AFTER FIRING ACROSS THE PA, THE STAPLE LINE WAS EXAMINED AND WAS INTACT. THE CASE WAS COMPLETED AND THE PATIENT WAS TAKEN TO RECOVERY. THE PATIENT WAS IN RECOVERY APPROXIMATELY 4-5 HOURS WHEN HE CODED. THE PATIENT WAS TAKEN BACK TO THE OR AND OPENED. THE SURGEON OBSERVED BLEEDING AT THE STAPLE LINE. HOWEVER, THE STAPLE WAS STILL INTACT, HE NOTED A TEAR AT THE DISTAL END OF THE STAPLE LINE. THE TEAR WAS REPAIRED USING SUTURES. AT THIS POINT, THE PATIENT HAD LOST A LARGE AMOUNT OF BLOOD AND EXPIRED ON THE TABLE. THE SALES SPOKE WITH THE SURGEON, HE ALLUDED TO THE FACT THAT THE PATIENT WAS ELDERLY, VERY ILL AND HAD UNDERGONE RADIATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDOPATH STAPLER NONE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death