BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 550295 · Received October 1, 2004

    Report

    Report Number
    MW1033529
    Event Type
    Malfunction
    Date Received
    October 1, 2004
    Date of Event
    September 20, 2004
    Report Date
    September 29, 2004
    Manufacturer
    H.S. INTERNATIONAL, INC.
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE SURGEON WAS USING BOVIE ON COAG, NOTICED LINES ON TV MONITOR. LAP BOVIE CORD WAS PLUGGED INTO MACHINE #5 AND IT STARTED A FLAME AT THE METAL PIECE. PLUG REMOVED FROM MACHINE #5 AND CORD, BURNED INTO, WAS DISCARDED. NEW CORD TO STERILE FIELD. SCISSORS ALSO SENT TO BE CHECKED BY BIOMED DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SCISSORS LRW H.S. INTERNATIONAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other CORD AND BOVIE MACHINE.