BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2930377 · Received January 22, 2013

    Report

    Report Number
    2937094-2013-00065
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF A PROCEDURE, THE LASER DID NOT POWER UP. AFTER CONSULTATION WITH MANUFACTURES TECHNICAL SUPPORT IT WAS DETERMINED THAT THE SYSTEM WAS NO LONGER ABLE TO BE UTILIZED. THE CASE WAS COMPLETED WITH ANOTHER LASER SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31180 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GREENLIGHT HPS LASER SYSTEM| ACCESSORIES