BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1071385 · Received July 9, 2008

    Report

    Report Number
    1527736-2008-03847
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 BY THE SALES REP THAT DURING A LAPAROSCOPIC ROUX-EN-Y BYPASS, THE DEVICE FIRED SUCCESSFULLY AT DIFFERENT ANATOMICAL POINTS WITH 2 WHITE LOADS AND 1 BLUE LOAD. ON THE 4TH, TOTAL FIRING OF DEVICE A LOUD "CRUNCHING" SOUND WAS HEARD AND THE DEVICE COULD NOT BE FIRED ANY FURTHER. THE MANUAL RELEASE LEVER WAS PULLED MULTIPLE TIMES AND THE ANVIL RELEASE BUTTON WAS PUSHED MULTIPLE TIMES. THE FIRING TRIGGER STILL REMAINED NEXT TO THE CLOSING TRIGGER - NO TRIGGERS WOULD OPEN OR RELEASE AND JAWS REMAINED CLAMPED ON TISSUE. AN ADD'L DEVICE WAS OPENED FROM STERILE PACKAGING AND USED TO CUT THE OTHER DEVICE FROM THE STOMACH. THERE WAS NO TISSUE TRAUMA EXPERIENCED. NO ADD'L PT BLEEDING OCCURRED AND NO SUTURE WAS NEEDED. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA E4KZ8W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention