BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 4971476 · Received August 5, 2015

    Report

    Report Number
    2937094-2015-00794
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 17, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE IN THE FIELD WAS PERFORMED ON (B)(4) 2015. THE RESONATOR S/N (B)(4) WAS RETURNED TO MANUFACTURER ON AUGUST 10, 2015. PRODUCT EVALUATION SUMMARY: THE RESONATOR S/N (B)(4) WAS EVALUATED ON AUGUST 18, 2015. THE EVALUATION NOTED THE REPORTED ¿ERRORS 211, 202 AND 111 POP UP DISPLAY¿ ISSUES WERE CONFIRMED. THE DIODE STACK, S/N (B)(4); SEVENTH BAR WAS NOTED TO BE DEAD. DIODE WITH S/N (B)(4) AND DESICCANT WERE REPLACED. THE RESONATOR WAS REALIGNED AND A NEW TEST REPORT WAS COMPLETED.

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON (B)(6) 2015. THE REPORTED ERROR CODES WERE VERIFIED AND DETERMINED TO BE THE RESULT OF A FAULTY RESONATOR. THE RESONATOR WAS REPLACED AFTER CALIBRATION / PERFORMANCE TEST. THE CHILLER SENSOR TEFLON SEAL WAS CHANGED. THE SYSTEM WAS TESTED AND VERIFIED TO SPECIFICATIONS. THE RESONATOR INSTALLED WAS S/N (B)(4) AND THE RESONATOR REMOVED S/N (B)(4) WAS RETURNED TO AMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ERROR CODES 211, 202 AND 111 OCCURRED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE PROCEDURE (TURP). PATIENT OUTCOME "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512557 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0077

    Patients

    Seq Age Sex Outcome Treatment
    1 Other