BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 4150229 · Received October 7, 2014

    Report

    Report Number
    2937094-2014-00902
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TOP COVER WAS RETURNED TO AMS ON SEPTEMBER 30, 2014 AND WAS SENT TO THE SUPPLIER.

    Additional Manufacturer Narrative · 1

    THE TOP COVER S/N (B)(4) WAS RETURNED TO AMS ON SEPTEMBER 30, 2014 AND WAS SENT TO THE SUPPLIER. PRODUCT EVALUATION: THE TOP COVER S/N (B)(4) WAS EVALUATED BY THE SUPPLIER ON DECEMBER 22, 2014. THE REPORTED ¿DURING PROCEDURE, SCREEN WENT BLANK¿ ISSUE WAS CONFIRMED; 24V LINE AND TANTALUM CAPACITORS WERE NOTED SHORTED. THE CAPACITORS WERE REPLACED AND TOP COVER WAS REPROGRAMMED. TOP COVER PASSED THE STANDARD PRODUCTION TEST. PROBABLE ROOT CAUSE: BASED ON SUPPLIER FA REPORT, THE ROOT CAUSE WAS DETERMINED TO BE THE CAPACITORS IN THE TOP COVER.

    Additional Manufacturer Narrative · 1

    THE CONSOLE WAS EVALUATED AND REPAIRED IN THE FIELD. THE REPORTED ISSUE WAS CONFIRMED AND WAS DETERMINED TO BE THE RESULT OF A FAULTY TOP COVER/TOUCH SCREEN DISPLAY. THE TOP COVER WAS REPLACED, THE SYSTEM TESTED AND VERIFIED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE SYSTEMS TOUCHSCREEN WENT BLANK; ATTEMPT TO REBOOT THE SYSTEM AND CONTINUE WITH THE PROCEDURE WERE UNSUCCESSFUL AND THE CASE WAS CANCELLED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627962 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1