BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2037605 · Received February 16, 2011

    Report

    Report Number
    2937094-2011-00169
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, DURING THE PROCEDURE, THE LASER SYSTEM HAD AN ERROR MESSAGE CODE 171 THAT OCCURRED. PER A CONFERENCE CALL BETWEEN THE CUSTOMER AND AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT, THE LASER'S POWER WAS SET AT 80W AND THEN TO 100W; THE POWER SETTING MAY HAVE BEEN RUNNING AT 90W. PER TECHNICAL SUPPORT, IT WAS ADVISED TO HAVE THE SETTINGS NO HIGHER THAN 100W TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMS, INNOVATION CENTER-SILICON VALLEY 0010-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other