BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 1963763 · Received December 22, 2010

    Report

    Report Number
    2937094-2010-01341
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    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 THERE WAS A DEVICE PORT OVERHEAT MESSAGE AT 8 WATTS FROM THE CONSOLE (AURAXP) OF THE LASER SYSTEM DURING THE MIDDLE OF THE PROCEDURE. THE CUSTOMER WAS ADVISED BY TECHNICAL SUPPORT TO DECREASE THE WATTAGE FROM 8 WATTS TO 7 WATTS IN ORDER TO CONTINUE THE PROCEDURE. PER THE CUSTOMER AND TECHNICAL SUPPORT, THE SAME DEVICE PORT OVERHEAT MESSAGE OCCURRED AT 7 WATTS AS WELL. THE CUSTOMER WAS NOT ABLE TO CONTINUE THE PROCEDURE WITH THIS DEVICE. THE PROCEDURE WAS ABORTED AND NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT XPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-8113 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other