BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOBEAM HOLMIUM LASER FIBERS

    MDR report key: 4196572 · Received October 17, 2014

    Report

    Report Number
    1018233-2014-00277
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 30, 2014
    Manufacturer
    LASER PERIPHERALS LLC
    Product Code
    GEX
    PMA / PMN Number
    K120926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER TIP BROKE DURING USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663376 ENDOBEAM HOLMIUM LASER FIBERS GEX LASER PERIPHERALS LLC NA BMYCG006

    Patients

    Seq Age Sex Outcome Treatment
    1