BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 1951860 · Received November 29, 2010

    Report

    Report Number
    1951860
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN OPEN APPENDECTOMY PROCEDURE, ON THE SECOND FIRING WITH A WHITE LOAD THE DEVICE FIRED PROPERLY HOWEVER THERE WAS OOZING AT THE STAPLE LINE. HEMOCLIPS WERE USED TO CONTROL THE BLEEDING AND TO COMPLETE THE PROCEDURE. THE AMOUNT OF BLOOD LOSS IS UNKNOWN AND THERE WAS NO NEED FOR A BLOOD TRANSFUSION.HEALTH PROFESSIONAL'S IMPRESSION: DEVICE CAUSED EXCESSIVE BLEEDING.MANUFACTURER RESPONSE FOR STAPLER, CUTTER, SURGICAL, ENDOPATH ETS: THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. TSB35 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR NO OTHER THERAPIES