BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER DIODE LASER FIBER

    MDR report key: 7609789 · Received June 18, 2018

    Report

    Report Number
    1037955-2018-00038
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    May 16, 2018
    Report Date
    May 21, 2018
    Manufacturer
    DORNIER MEDTECH LASER GMBH
    Product Code
    GEX
    PMA / PMN Number
    K083500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE FIBER ARRIVED STERILIZED INSIDE A PLASTIC BAG. A VISUAL EXAMINATION WAS CONDUCTED. AN INSPECTION OF THE PROXIMAL AND DISTAL ENDS OF THE FIBER ABLE SHOWED THAT IT IS UNLIKELY THE FIBER HAS BEEN USED. A BREAK WAS OBSERVED. (B)(4) PER EXEMPTION NUMBER E2012001.

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE AT THIS POINT DUE TO THE FACT THAT THE OEM'S INVESTIGATION IS STILL PENDING. ONCE INVESTIGATION IS COMPLETED AND RECEIVED BY DORNIER MEDTECH AMERICA, INC., THIS REPORT WILL BE AMENDED. DORNIER MEDTECH AMERICA, INC. (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH LASER GMBH (THE MANUFACTURER) PER EXEMPTION NUMBER E2012001.

    Description of Event or Problem · 0

    CUSTOMER CALLED AND STATED THE FIBER WAS BROKEN OUT OF THE BOX.

    Description of Event or Problem · 0

    CUSTOMER CALLED AND STATED THE FIBER WAS BROKEN OUT OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454823 DORNIER DIODE LASER FIBER DIODE LASER FIBER GEX DORNIER MEDTECH LASER GMBH 400 MICRON REUSABLE DIODE FIBER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1