BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 3704207 · Received March 27, 2014

    Report

    Report Number
    2937094-2014-00221
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON MARCH 19, 2014: THE ¿SAFETY SHUTDOWN AND UNKNOWN ERROR CODE¿ WAS NOT CONFIRMED. THE SYSTEM CHECK NOTED ROLL CALL ERRORS TO THE DISPLAY. THE DISPLAY WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER¿S SPECIFICATIONS. THE TOP COVER WAS RETURNED TO AMS ON MARCH 25, 2014 AND WAS SENT TO SUPPLIER.

    Additional Manufacturer Narrative · 1

    THE TOP COVER WAS RETURNED TO AMS ON (B)(6) 2014 AND WAS SENT TO THE SUPPLIER. PRODUCT EVALUATION: THE TOP COVER WAS EVALUATED BY THE SUPPLIER ON (B)(6) 2014. THE REPORTED ¿ERRORS 807, 821, 515 AND 302.13¿ ISSUES WERE NOT CONFIRMED AND NO PROBLEM WAS FOUND. THE TOP COVER PASSED THE STANDARD PRODUCTION TEST. PROBABLE ROOT CAUSE: BASED ON SUPPLIER FU REPORT, THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE "CONSOLE HAD ERROR CODES 302.13, 515, 807 AND 821". THE CASE WAS COMPLETED WITH A "TURP".PATIENT OUTCOME: NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182195 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