BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 3193179 · Received June 25, 2013

    Report

    Report Number
    1037955-2013-00011
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    April 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    022544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS LIKELY THAT THE THREE FIBER BREAKS OCCURRED DUE TO AN EXTERNAL MECHANICAL FORCE STRIKING THE FIBER IN THE THREE AREAS WHERE THE BREAKS OCCURRED. DUE TO THESE VISIBLE CHARACTERISTICS OF THE BREAKS, THE EVENT IN WHICH THE BREAKS OCCURRED (FIBER REPROCESSING/CLEANING) AND THEIR CLOSENESS IN PROXIMITY, IT IS HYPOTHESIZED THAT THE THREE SEPARATE FIBER BREAKS WERE CAUSED BY THE ROTATING ARM OF A MEDICAL DEVICE CLEANING APPARATUS. IT IS LIKELY THAT THE FIBER WAS NOT COILED PROPERLY DURING CLEANING AND BECAME ENTANGLED IN THE ROTATING ARMS OF A MEDICAL DEVICE CLEANING MACHINE DURING REPROCESSING/CLEANING.

    Description of Event or Problem · 1

    SEVERAL CRACKS VISIBLE IN THE HOLMIUM FIBER AFTER TAKING FIBER OUT OF WASHING MACHINE DURING DEVICE REPROCESSING. THE CLINIC THAT WAS REPROCESSING THE FIBER IS EXPERIENCED WITH HOLMIUM FIBERS AND CLAIMED TO BE APPLYING THE USUAL DISINFECTION PROCEDURES. THE EVENT OCCURRED IN (B)(4) AND WAS REPORTED TO DORNIER MEDTECH AMERICA, INC. ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288804 DORNIER HOLMIUM LASER FIBER LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2011953 F3410R

    Patients

    Seq Age Sex Outcome Treatment
    1