BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRALINE FREE BEAM LASER

    MDR report key: 14573 · Received July 8, 1994

    Report

    Report Number
    MW1002761
    Event Type
    Malfunction
    Date Received
    July 8, 1994
    Date of Event
    June 24, 1994
    Report Date
    July 7, 1994
    Manufacturer
    HERAEUS SURGICAL, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSOLE REGISTERED "FIBER FAULT" AND THE LASERS DID NOT FUNCTION. RECONNECTING THE DEVICES DID NOT HELP. IN BOTH CASES ANOTHER FIBER WAS USED WHICH WORKED FINE. EVENT DATE SHOWN AS 6/24 AND 6/27/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALINE FREE BEAM LASER FREE BEAM LASER GEX HERAEUS SURGICAL, INC. 011294

    Patients

    Seq Age Sex Outcome Treatment
    1 *