BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGABEAM ENDO-ENT PROBE

    MDR report key: 3697182 · Received March 18, 2014

    Report

    Report Number
    3697182
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 18, 2014
    Manufacturer
    BIOLITEC MEDICAL DEVICES INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ARGON LASER WAS TURNED ON TO USE WITH A BIOLITEC MEGABEAM ENDO-ENT PROBE. STARTED AT USUAL SETTINGS OF 1 WATT, 0.2 DURATION. SURGEON REQUESTED INCREASING POWER SETTINGS DUE TO LASER NOT WORKING EFFECTIVELY. CERTIFIED SURGICAL TECHNOLOGIST THEN NOTED THAT THE FIBER WIRE WAS GLOWING. THE FIBER WIRE WAS REPLACED AND THE LASER PERFORMED AT ORIGINAL SETTINGS WITHOUT A PROBLEM. THE SURGERY WAS ABLE TO BE COMPLETED AND THERE WERE NO COMPLICATIONS. NOTE: IT WAS A NEW FIBER, NOT A RE-STERILIZED FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157855 MEGABEAM ENDO-ENT PROBE POWERED LASER SURGICAL INSTRUMENT GEX BIOLITEC MEDICAL DEVICES INC. * A13-0260-0

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR