BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURA XP USA LASER SYSTEMS

    MDR report key: 3140086 · Received May 29, 2013

    Report

    Report Number
    2937094-2013-00621
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K951034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, WITH A PT UNDER ANESTHESIA, THE LASER TURNED ON WITH NO ERROR MESSAGES, BUT WHEN LASED, NO HEAT AT END OF THE FIBER AND NO TISSUE EFFECT WAS OBSERVED. TWO FIBERS WERE USED. THE CASE COULD NOT BE COMPLETED. NO FURTHER INFO IS AVAILABLE. PT OUTCOME: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236529 AURA XP USA LASER SYSTEMS POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-8113

    Patients

    Seq Age Sex Outcome Treatment
    1 SURGICAL FIBERS(S)