BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM FIBER

    MDR report key: 4071617 · Received August 12, 2014

    Report

    Report Number
    1037955-2014-00010
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 21, 2014
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K121938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH FIBERS EXHIBITED EVIDENCE OF FIBER BURN BACK. THE FIBER BURN BACK WAS LIKELY CAUSED DURING FIBER DIRECT CONTACT WITH A KIDNEY STONE. SUCH BURN BACK CAN OCCUR DURING NORMAL LASER LITHOTRIPSY WHEN THE FIBER CONTACTS A STRONG SIDE OF THE STONE AND TOO HIGH OF SHOCK FORCES (HIGH LASER ENERGY SETTINGS) ARE USED TO FRAGMENT THE STONE. FIBER BURN BACK WOULD LIKELY NOT HAVE OCCURRED IF LOWER LASER ENERGY SETTINGS WERE USED DURING SUCH A CASE. NO FAULT WITH EITHER FIBER AS MANUFACTURED.

    Description of Event or Problem · 1

    LASER FIBER LASTED 2-3 MINUTES ON 15, 20, AND 30 WATTS. LASERS FIRED AT END AND NOT USABLE. FIBER BREAK REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479152 DORNIER HOLMIUM FIBER HOLMIUM FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013062 F0314S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other