BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STONELIGHT LASER SYSTEM

    MDR report key: 3213336 · Received July 3, 2013

    Report

    Report Number
    2937094-2013-00725
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 11, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K994273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR WITH THEIR LASER SYSTEM. IT WAS REPORTED THAT DUE TO THIS ERROR THE "CASE WAS COMPLETED USING ANOTHER TECHNIQUE". THE OUTCOME WAS REPORTED AS "NO DAMAGES TO THE PT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303460 STONELIGHT LASER SYSTEM POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-9260

    Patients

    Seq Age Sex Outcome Treatment
    1 Other