BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY LLC

    MDR report key: 2440444 · Received January 31, 2012

    Report

    Report Number
    MW5024110
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 31, 2012
    Manufacturer
    ETHICON ENDO SURGERY INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE OPERATING ROOM NURSES, THE HARMONIC ACE STOPS WORKING DURING THE PROCEDURE WHENEVER HARMONIC GENERATOR # (B)(4) FLASHES "RELEASE TENSION ON TIP" OR "LOOSEN PRESSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY LLC HARMONIC GENERATOR LFL ETHICON ENDO SURGERY INC. 1111136142

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR