BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 975349 · Received July 13, 2007

    Report

    Report Number
    1037955-2007-00021
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    January 4, 2005
    Report Date
    July 5, 2007
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    LNK
    PMA / PMN Number
    022544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LASER STONE EXTRACTION - 200 MICRON LASER FIBER BROKE AT POINT OF ENTRY INTO CYSTOSCOPE, RETAINED FIBER REMOVED FROM THE CYSTOSCOPE. ANOTHER 200 MICRON FIBER WAS USED (LOT A1504-16S) THE SAME BREAKAGE OCCURRED. RN STATED THAT THE ACMI COMPANY HAS HAD PROBLEMS REPORTED AND IS STOPPING PRODUCTION OF 200 FIBER. NO RECALL ON THE 200 FIBERS WAS SENT BY THE COMPANY. NO INFO PROVIDED ON THE EVENT SITE OR CONTACT SO FOLLOW-UP CANNOT BE DETERMINED BY DORNIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER HOLMIUM LASER FIBER LASER FIBER LNK DORNIER MEDTECH AMERICA, INC. HF0200DSSM A1504-16S

    Patients

    Seq Age Sex Outcome Treatment
    1 *