BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 1812800 · Received July 21, 2010

    Report

    Report Number
    1037955-2010-00013
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    May 25, 2010
    Report Date
    July 20, 2010
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    022544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DATA FROM FDA RECEIVED MAUDE REPORT (B)(4): HOLMIUM LASER STARTED MAKING POPPING SOUNDS. LIGHT GLIDE (GUIDE) CHANGED IMMEDIATELY. UOR WAS DONE. LASER FIBER COMES 3 EACH IN BOX. WE DIDN'T HAVE ANY PROBLEM WITH OTHER TWO FIBERS AND USED MANY TIMES WITH OTHER LOT NUMBER'S FIBER. HAS BEEN NO PROBLEM. DIAGNOSIS OR REASON FOR USE: URETER STONE. NO COMPLAINT WAS FILED WITH THE DISTRIBUTOR (GYRUS ACMI) OR WITH THE MANUFACTURER (DORNIER MEDTECH (B)(4)). MAUDE REPORT WAS SENT TO DISTRIBUTOR AND THEN FORWARDED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER HOLMIUM LASER FIBER LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. DUR400D B0410S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other