BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2073654 · Received April 13, 2011

    Report

    Report Number
    2937094-2011-00639
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 IN THE MIDDLE OF THE PROCEDURE ERROR 102.10 WAS RECEIVED FROM THE LASER SYSTEM. PER THE CUSTOMER, THE LASER SYSTEM WENT INTO SAFETY SHUT DOWN TWICE. ALSO, THE CUSTOMER REPORTED THE LASER SYSTEM WAS RE-BOOTED. PER THE CUSTOMER, THE PROCEDURE WAS ABLE TO BE COMPLETED. NO PATIENT 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 0010-0210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other