BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2066753 · Received March 30, 2011

    Report

    Report Number
    2937094-2011-00476
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE PROCEDURE, THE LASER SYSTEM HAD A FIBER CARD ERROR MESSAGE READING. PER THE CUSTOMER, TWO FIBERS/FIBER CARDS FROM THE SAME LOT NUMBER (10-2400-106A) WERE USED. THE LASER SYSTEM WAS RE-BOOTED AND CYCLED. THE ERROR MESSAGE COULD NOT BE CLEARED. PER THE CUSTOMER, A FIBER/FIBER CARD FROM ANOTHER LOT NUMBER WAS USED. THE FIBER CARD ERROR MESSAGE WAS CLEARED. THE PROCEDURE WAS COMPLETED.

    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 0010-0210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other