BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHE WIRE "L" HOOK TIP

    MDR report key: 1887482 · Received October 27, 2010

    Report

    Report Number
    1717344-2010-00755
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RETURNED, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGEON NOTICED THAT ENERGY CAME OUT FROM THE INSULATION NEXT TO THE HOOK DURING SURGERY. THE PT'S LIVER WAS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LHE WIRE "L" HOOK TIP ES ACCESSORY HWE COVIDIEN LP (VALLEYLAB) 180934

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK