BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 3851991 · Received June 5, 2014

    Report

    Report Number
    2937094-2014-00448
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE IN FIELD PERFORMED (B)(6) 2014. RESONATOR S/N (B)(4) RETURNED TO AMS AND ANALYSIS PERFORMED ON (B)(6) 2014. PRODUCT EVALUATION SUMMARY: THE EVALUATION OF THE RESONATOR REVEALED SECOND BAR ON THE DIODE WAS BURNT; YAG ROD WAS BROKEN. DURING TRANSFER, THE RESONATOR BASE PLATE AND WALLS WERE DAMAGED. THE COUPLER COVER WAS NOTED TO BE STUCK. DIODE, BASE PLATE, WALLS, YAG ROD, COUPLER COVER AND DESICCANT WERE REPLACED. THE RESONATOR WAS RE-PEAKED AND A NEW TEST REPORT WAS COMPLETED.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR: THE REPORTED ERROR CODE(S) WERE CONFIRMED AND DETERMINED TO BE THE RESULT OF A FAULTY RESONATOR. THE RESONATOR WAS REPLACED AND THE SYSTEM TESTED AND VERIFIED TO MANUFACTURERS SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS WAS REPORTED THAT THE CUSTOMER EXPERIENCED A SYSTEM MALFUNCTION DURING A PROCEDURE (ERROR 210-235). THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE (ALTERNATE PROCEDURE).THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328639 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1