BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERCHTOLD

    MDR report key: 717669 · Received April 27, 2006

    Report

    Report Number
    MW1038899
    Event Type
    Injury
    Date Received
    April 27, 2006
    Date of Event
    April 11, 2006
    Report Date
    April 12, 2006
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGICAL LIGHT SOURCE THAT WILL "ARC AND SPARK" AT HEAD OF LIGHT. SURGICAL LIGHT HAS 2(ANO) THUMB SCREWS TO HOLD LIGHT HEAD IN UNIT. WITH AN ACCEPTABLE AMOUNT OF FORCE LIGHT HEAD WILL SLIGHTLY DISCONNECT CAUSING SPARKING, FLICKERING, AND CRACKLING OF ELECTRICITY. REPORTED TO MFR NUMEROUS TIMES ONLY TO BE TOLD THEY ARE AWARE AND WILL SELL "UPGRADE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERCHTOLD SURGICAL LIGHT FQP BERCHTOLD CORP C-571 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention