BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1112568 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01095
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 28, 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
    IS
    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 SLEEVE GASTRECTOMY PROCEDURE, DURING THE FOURTH FIRING OF THE STAPLE LINE, THE STAFF USED A BLUE RELOAD. THE FIRING SEQUENCE COMPLETED CORRECTLY ACCORDING TO STAFF. AFTER OPENING THE DEVICE'S JAWS THEY NOTICED THAT THE KNIFE DID CUT THROUGH THE TISSUE BUT THE STAPLE FORMATION WAS POORLY SHAPED. THE STAPLES WERE PARTLY OPENED AND NOT ALIGNED WITH THE STAPLE CROWN. THE SURGEON CONTINUED USING THE SAME DEVICE TO COMPLETE THE STAPLE LINE. AT THE MISSED FIRE AREA, HE HAD TO SUTURE IT. SURGERY WAS PROLONGED SIXTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, LLC. NA E4LE0E

    Patients

    Seq Age Sex Outcome Treatment
    1