BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2037620 · Received February 16, 2011

    Report

    Report Number
    2937094-2011-00172
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE PROCEDURE, AN ERROR MESSAGE CODE 171 OCCURRED. PER A CONFERENCE CALL BETWEEN THE CUSTOMER AND AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT, THE LASER'S POWER WAS SET AT 80W. PER TECHNICAL SUPPORT, IT WAS ADVISED TO INCREASE THE POWER. PER THE CUSTOMER, THE POWER WAS INCREASED TO 90W. THE PROCEDURE WAS RESUMED.

    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