BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER LIGHT SOURCE

    MDR report key: 21684 · Received May 4, 1995

    Report

    Report Number
    MW1005828
    Event Type
    Malfunction
    Date Received
    May 4, 1995
    Date of Event
    March 28, 1995
    Report Date
    April 12, 1995
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    FTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, SMOKE AND FIRE WERE NOTED COMING FROM THE MICROSCOPE LIGHT SOURCE AFTER THE INTENSITY WAS TURNED TO HIGH. EXAMINATION BY BIO-ELECTRONICS STAFF REVEALED THAT THE XENON LAMP HIGH VOLTAGE SUPPLY HAD BURNED UP. UNIT HAS BEEN RETURNED TO CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBER LIGHT SOURCE FIBER LIGHT SOURCE FTB CARL ZEISS, INC. SUPER 300

    Patients

    Seq Age Sex Outcome Treatment
    1 *