BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 4152199 · Received October 8, 2014

    Report

    Report Number
    2937094-2014-00909
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON OCTOBER 2, 2014: THE ¿ERROR CODED 833, 509¿ TOUCH SCREEN NOT OPERATIONAL ISSUE WAS CONFIRMED AND DETERMINED TO BE THE RESULT OF A FAULTY TOP COVER/TOUCH SCREEN. THE TOP COVER WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER¿S SPECIFICATIONS. THE TOP COVER WAS RETURNED TO AMS ON OCTOBER 16, 2014 AND WAS SENT TO THE SUPPLIER.

    Additional Manufacturer Narrative · 1

    THE TOP COVER S/N (B)(4) WAS RETURNED TO AMS ON OCTOBER 16, 2014 AND WAS SENT TO THE SUPPLIER. PRODUCT EVALUATION: THE TOP COVER WAS EVALUATED BY SUPPLIER ON DECEMBER 22, 2014. THE REPORTED ¿BLANK SCREEN¿ ISSUE WAS CONFIRMED; 24V LINE AND TANTALUM CAPACITORS WERE NOTED SHORTED. THE CAPACITORS WERE REPLACED; TOP COVER WAS REPROGRAMMED AND PASSED THE STANDARD PRODUCTION TEST. PROBABLE ROOT CAUSE: BASED ON THE SUPPLIER FA REPORT, THE ROOT CAUSE WAS DETERMINED TO BE THE CAPACITORS IN THE TOP COVER.

    Description of Event or Problem · 1

    INFORMATION AS IT WAS REPORTED TO AMS INDICATES THAT THE "TOUCHSCREEN NOT OPERATIONAL (BLANK)" PATIENT WAS SEDATED. THE CUSTOMER WAS UNABLE TO RESOLVE THE DISPLAY ISSUE THAT OCCURRED AND THE CASE WAS COMPLETED BY AN ALTERNATIVE PROCEDURE (TURP). PATIENT OUTCOME WAS "OK" REPORTED. THERE WAS NO REPORT OF A PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630523 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other