BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOMIUM LASER FIBER

    MDR report key: 4110716 · Received September 16, 2014

    Report

    Report Number
    1037955-2014-00013
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K121938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCATION OF THE BREAK POINT, EVIDENCE OF CHARRING, AND LACK OF HEAT SHRINK ELONGATION INDICATE THAT THE BREAK OCCURRED WHILE LASER ENERGY WAS BEING TRANSMITTED THROUGH THE FIBER. IN ADDITION, THE LOCATION OF THE BREAK POINT NEAR THE CONNECTION PORT OF THE LASER IS INDICATIVE OF AN EXTERNAL FORCE, SUCH AS AN ACCIDENTAL BUMP BY PERSONNEL USING THE LASER, COMING IN CONTACT WITH THE FIBER CAUSING IT TO BAND EXCESSIVELY WHILE LASER ENERGY WAS BEING APPLIED. IT IS LIKELY THAT THE FIBER BREAK WAS CAUSED BY THE END USER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE FIBER HAD SPLIT EVEN BEFORE USE. THE DATE OF THE INCIDENT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572026 DORNIER HOMIUM LASER FIBER HOLMIUM FIBER GEX DORNIER MEDTECH AMERICA, INC. HLFDBX0270C F4913S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other