BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1802899 · Received August 11, 2010

    Report

    Report Number
    MW5017080
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PRODUCT IS PLUGGED IN A SELF TEST IS COMPLETED AND DURING THE SELF TEST THERE IS DEFAULT CODE IS GIVEN WHICH NOTIFIES YOU THAT THE HANDPIECE IS BAD. WHILE NO EVENT HAS ACTUALLY OCCURRED, THE CONCERN IS IF THE ALARM FAILS AND PRODUCT MAKES IT PAST THE SELF TEST AND IS UTILIZED ON A PT, PROPER SEALING TO THE BOWEL MAY NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENSEAL TRIO GEI ETHICON ENDO-SURGERY, INC F09H06
    2 ETHICON ENSEAL TRIO GEI ETHICON ENDO-SURGERY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR