BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2037627 · Received February 16, 2011

    Report

    Report Number
    2937094-2011-00166
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THAT AT THE BEGINNING OF THE PROCEDURE ERRORS 330 AND 652 OCCURRED. PER THE CUSTOMER, THE PROCEDURE WAS ABORTED AS THE ERRORS WOULD NOT CLEAR. NO PT INJURY WAS REPORTED. AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT CONFIRMED WITH THE CUSTOMER THAT WATER WAS FULL IN THE LASER AND THAT THE CHILLER FAN WAS COMING ON. THE CUSTOMER CONFIRMED THAT THE CHILLER WAS COMING ON BUT STILL RECEIVED THE SAME ERRORS. PER THE CUSTOMER, THE LASER WAS SHUT OFF/ON AND WAS UNABLE TO CLEAR THE ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT XPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMS, INNOVATION CENTER-SILICON VALLEY 0010-0210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other