BEUDAMED
    FDA Adverse Event Summary report: N

    CERAMOPTEC

    MDR report key: 281393 · Received June 8, 2000

    Report

    Report Number
    MW1019095
    Date Received
    June 8, 2000
    Date of Event
    June 6, 2000
    Report Date
    June 8, 2000
    Manufacturer
    CERAMOPTEC, INC.
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF LASER FIBER BROKE OFF WHEN DOING A LASER TURBINOPLASTY. WHEN THE FIBER, WHICH WAS SECURED TO SUCTION TUBING WAS REMOVED FROM THE HOSE IT WAS NOTED TO HAVE THE TIP OF THE FIBER MISSING. THE LASER USED WAS A HOLMIUN. THE SETTINGS WERE 1.2 JOULES, ENERGY WAS 14, WATTS OF 16.8. THE TIP OF THE FIBER WAS NOT LOCATED. NO INJURIES REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMOPTEC LASER FIBER SMA 400 UM BASE FIBER ASSY GEX CERAMOPTEC, INC. HBFSF 363-403 A9-0291

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR