BEUDAMED
    FDA Adverse Event Other Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 991113 · Received February 1, 2008

    Report

    Report Number
    1037955-2007-00066
    Event Type
    Other
    Date Received
    February 1, 2008
    Date of Event
    November 20, 2007
    Report Date
    January 17, 2008
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    02544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LASER FIBER WAS EVALUATED BY MANUFACTURER. FIBER BREAK OCCURRED 7 INCHES FROM THE PROXIMAL TIP OF THE FIBER. THE BREAK SITE WAS CHARRED INDICATING THAT THE FIBER WAS BEING FIRED WHEN THE BREAK OCCURRED. THE LOCATION OF THE BREAK WOULD INDICATE THAT THE USER CONTACTED THE FIBER INADVERTENTLY CAUSING THE BREAK.

    Description of Event or Problem · 1

    LASER FIBER BROKE AND THEN SPARKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER HOLMIUM LASER FIBER LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. HF0400DSSM B5006-07S

    Patients

    Seq Age Sex Outcome Treatment
    1