BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 3255778 · Received July 22, 2013

    Report

    Report Number
    2937094-2013-00785
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE LASER DISPLAYED AN ERROR INDICATIVE OF A RESONATOR MALFUNCTION. THE CUSTOMER WAS UNABLE TO CLEAR THE ERROR THAT OCCURRED. THE PHYSICIAN REVERTED TO AN ALTERNATIVE DEVICE, GYRUS PKU SUPERPULSE GENERATOR, TO COMPLETE THE CASE. PT OUTCOME: "NO COMPLICATIONS REPORTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341694 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other