BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 1944025 · Received December 29, 2010

    Report

    Report Number
    2937094-2010-01486
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER ON (B)(6) 2010, THAT THE LASER SYSTEM RECEIVED AN ERROR 171 AT 120 WATTS. THE LASER SYSTEM RECEIVED THIS SAME ERROR 3 TIMES AND WAS ABLE TO BE CLEARED EACH TIME. PER THE CUSTOMER, THE WATTAGE WAS REDUCED TO 100 WATTS AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO PROBLEMS. ALSO, THE CUSTOMER LATER REPORTED THAT THE LASER SYSTEM LATER RECEIVED AN ERROR 210 AND ERROR 230.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other