BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 5512986 · Received March 20, 2016

    Report

    Report Number
    2937094-2016-00299
    Event Type
    Injury
    Date Received
    March 20, 2016
    Date of Event
    September 16, 2013
    Report Date
    March 10, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON SEPTEMBER 23, 2013: THE REPORT OF ¿WATER LEAK FROM CHILLER¿ WAS NOTED, THE CHILLER WAS REPLACED AND PD1 CALIBRATION DONE. THE SYSTEM WAS TESTED AND READY FIRED TO MEET MANUFACTURERS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER UPDATED SYSTEM ANALYSIS/SERVICE REPAIR IN THE FIELD WAS PERFORMED ON SEPTEMBER 23, 2013. THE REPLACED CHILLER WAS RECEIVED AT THE MANUFACTURER ON MARCH 22, 2016. PRODUCT EVALUATION: THE CHILLER WAS NOTED TO BE "OLD REVISION" AND WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR IN THE FIELD WAS PERFORMED ON SEPTEMBER 23, 2013. THE REPLACED CHILLER WAS RECEIVED AT THE MANUFACTURER ON MARCH 22, 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE CONSOLE HAD A MESSAGE "WHEN XPS RUNNING APPEAR, ADDITION DI WATER MESSAGE THEN XPS SHUTDOWN". THE CASE WAS CHANGED TO A "TURP". PATIENT OUTCOME: "NO INJURY TO THE PATIENT REPORTED">

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169000 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other