BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 3201312 · Received June 26, 2013

    Report

    Report Number
    2937094-2013-00706
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODE DISPLAY REFERS TO THE RESULTS CODE ELECTRICAL PROBLEM. SYSTEM FIELD SERVICE ANALYSIS: THE REPORTED ERROR CODE 173 WAS VERIFIED. THE LASER SYSTEM WAS TESTED AND POWER COULD NOT BE OBTAINED AT ANY CURRENT SETTING. ADDITIONAL ANALYSIS DETERMINED THAT THE LASER RESONATOR WILL NEED TO BE REPLACED. THE CUSTOMER WAS PROVIDED A QUOTE FOR REPAIR, HOWEVER NO PARTS WERE USED/REPLACED, AS THE CUSTOMER HAS CHOSEN NOT TO REPAIR THE LASER SYSTEM AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, AN ERROR MESSAGE 173 WAS OBSERVED (INDICATING A RESONATOR ISSUE). THE ERROR COULD NOT BE CLEARED AND THE PROCEDURE WAS NOT COMPLETED. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289486 GREENLIGHT HPS LASER SYSTEM POWERED SURGICAL LASER INSTRUMENTS GEX AMERICAN MEDICAL SYSTEMS 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1