BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGON MEDICAL/ MAXXIM MEDICAL

    MDR report key: 488876 · Received October 8, 2003

    Report

    Report Number
    488876
    Event Type
    Malfunction
    Date Received
    October 8, 2003
    Date of Event
    September 29, 2003
    Report Date
    October 7, 2003
    Manufacturer
    MAXXIM MEDICAL
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY AFTER ABC BOVIE HANDPIECE WAS USED, ELECTRODE WAS PLACED ON DRAPE. ELECTRODE BURNED 4 PEA-SIZED HOLES ON DRAPES. NO PROBLEM WITH BOVIE AND NO USER ERROR. RPTR SUSPECTS FABRIC PROBLEM. NO HARM TO PATIENT. SECOND SUCH EVENT TODAY. DIFFERENT BOVIES. DIFFERENT SURGEONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON MEDICAL/ MAXXIM MEDICAL DRAPE KKX MAXXIM MEDICAL * 99372674

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other