BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON DIOXIDE LASER

    MDR report key: 13231 · Received May 13, 1994

    Report

    Report Number
    MW1001971
    Event Type
    Malfunction
    Date Received
    May 13, 1994
    Date of Event
    November 18, 1993
    Report Date
    April 10, 1994
    Manufacturer
    SHARPLAN LASERS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A LASER FAILED 3 TIMES WITHIN A FOUR MONTH PERIOD. THE SAME PROBLEM CAUSED ALL 3 FAILURES. A CRACKED FLOW SENSOR CAUSED A LEAK IN THE COOLANT SYSTEM, AND A LOW COOLANT FLOW ALARM. THE PROBLEM COULD HAVE BEEN MUCH WORSE IF A STANDBY LASER HAD NOT BEEN AVAILABLE. THE CO WAS NOT MUCH HELP DURING THIS PROCESS. THE CO INSTALLED THE FIRST FLOW SENSOR; IT FAILED WITHIN 30 DAYS. RPTR HAS REPLACED THE OTHER TWO FLOW SENSORS. HIS NEXT STEP WILL BE TO USE A METAL FLOW SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBON DIOXIDE LASER CARBON DIOXIDE LASER GEX SHARPLAN LASERS, INC. 1041

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other