BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 4221610 · Received November 3, 2014

    Report

    Report Number
    2937094-2014-00993
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON NOVEMBER 04, 2014: THE REPORTED ¿BLACK SCREEN AND LASER CANNOT SWITCH ON¿ ISSUE WAS CONFIRMED AND DETERMINED TO BE THE RESULT OF A FAULTY TOP COVER. THE TOP COVER WAS REPLACED. THE FIBER PORT WAS CLEANED AND LEAK ON CHILLER WAS SECURED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET AMS SPECIFICATIONS. THE TOP COVER WAS RETURNED TO AMS ON DECEMBER 10, 2014 AND WAS SENT TO THE SUPPLIER. SUPPLIER ANALYSIS REPORT: THE TOP COVER WAS EVALUATED BY THE SUPPLIER ON JULY 02, 2015. THE REPORTED ¿BLACK SCREEN¿ ISSUE WAS CONFIRMED. THE 24V LINE AND TANTALUM CAPACITORS WERE NOTED SHORTED. THE CAPACITORS WERE REPLACED, REPROGRAMMED AND THE DISPLAY SCREEN PASSED THE STANDARD PRODUCTION TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿JUST BEFORE¿ A PROSTATE PROCEDURE THE, "LASER DID NOT WARM UP - BLACK SCREEN." THE PHYSICIAN REVERTED TO AN ALTERNATIVE PROCEDURE (MONOPOLAR RESECTION) TO PERFORM AND COMPLETE THE PROCEDURE. ¿NO PATIENT OR USER INJURY¿ REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702248 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