BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 4259959 · Received November 18, 2014

    Report

    Report Number
    2937094-2014-01057
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON DECEMBER 18, 2014: THE REPORTED ¿ERRORS 210, 831 AND 235¿ WERE CONFIRMED. THE LASER SYSTEM WAS INSPECTED AND WAS DETERMINED THAT POWER SUPPLY WAS REQUIRED TO RESOLVE THE ISSUES. THE LASER POWER SUPPLY (LPS) WAS REPLACED HOWEVER ISSUES WERE NOT RESOLVED. THE RESONATOR WAS THEN REPLACED AND RESONATOR S/N (B)(4) WAS INSTALLED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER¿S SPECIFICATIONS. PRODUCT EVALUATION SUMMARY: THE RESONATOR S/N (B)(4) WAS EVALUATED ON JANUARY 05, 2015. THE EVALUATION DETECTED RED AND BLACK CABLES WERE NOT CONNECTED; DIODE AND R2 OPTIC BOTH WERE NOTED TO BE BURNT. REPLACED DIODE S/N (B)(4), R2 OPTIC LOT 213490 AND DESICCANT. THE RESONATOR WAS REALIGNED AND A NEW TEST REPORT WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AMS THAT DURING A PROSTATE PROCEDURE WITH THE PATIENT UNDER ANESTHESIA, THE LASER DISPLAYED ERROR CODES 210, 235 AND 831. THE CUSTOMER WAS UNABLE TO CLEAR THE ERRORS THAT OCCURRED. THE PHYSICIAN ABORTED THE CASE WITH HPS; ¿WILL CONTINUE WITH ALTERNATE METHOD AT HIS DISCRETION¿. THERE WAS ¿NO INJURY TO PATIENT AT TIME OF CALL¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744723 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1