BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1213545 · Received October 27, 2008

    Report

    Report Number
    MW5008783
    Event Type
    Malfunction
    Date Received
    October 27, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 26, 2008
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, THE TIP WHITE OF THE HARMONIC ACE36E, USED FOR COAGULATION AND CUTTING OF TISSUE CAME OFF THE TIP CAUSING IT TO BE METAL ON METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON HARMONIC ACE LFL ETHICON ENDO SURGERY ACE E4M656

    Patients

    Seq Age Sex Outcome Treatment
    1