BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2092085 · Received April 27, 2011

    Report

    Report Number
    2937094-2011-00851
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011 DURING THE PROCEDURE ERROR MESSAGE 171 WAS REC'D AT 180 WATTS FROM THE LASER SYS. PER THE CUSTOMER, THIS ERROR WAS ABLE TO BE CLEARED. THE CUSTOMER REPORTED THE ONLY WAY THE PROCEDURE WAS CONTINUED WAS TO KEEP LOWERING THE WATTAGE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other