BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 3052903 · Received April 1, 2013

    Report

    Report Number
    2937094-2013-00427
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE THE LASER SYSTEM TURNED OFF AND RESTARTED TWICE. THE PHYSICIAN REVERED TO AN ALTERNATIVE SURGICAL PROCEDURE TURP TO COMPLETE THE CASE. PATIENT OUTCOME: "NO HARM; PATIENT CONDITION OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133359 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-0075 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other