BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 6794230 · Received August 15, 2017

    Report

    Report Number
    2937094-2017-00724
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 2, 2017
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE REPAIR WAS COMPLETED IN THE FIELD ON NOVEMBER 07, 2017. THE FRU LPS WAS RECEIVED AT THE MANUFACTURER ON FEBRUARY 01, 2018.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE RETURNED RESONATOR WAS EVALUATED ON JANUARY 25, 2018 AND NOTED "NO PACKAGING DAMAGE ON CRATE; NO EXTERNAL DAMAGE FOUND ON RESONATOR, UNABLE TO PRODUCE ERROR ON TEST BENCH, INSPECTED AND REPEAKED RESONATOR AND CREATED A NEW TEST REPORT. PROBABLE ROOT CAUSE: BASED ON FA RESULTS, THE PROBABLE ROOT CAUSE OF ERROR 211 WAS UNDETERMINED. THE RETURNED FRU LPS WAS DISPOSITION TO BE SCRAPPED ONCE THE FA IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CONSOLE WAS EVALUATED IN THE FIELD ON (B)(6) 2017: THE REPORTED ISSUE OF ¿ERROR 211¿ WAS CONFIRMED. DIODE STACK WAS SUSPECTED TO BE FAULTY AND A NEW RESONATOR IS REQUIRED. SERVICE REPAIR HAS NOT BEEN COMPLETED YET.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE LPS EVALUATION WAS COMPLETED ON FEBRUARY 22, 2018 AND NOTED NO PACKAGING DAMAGE ON THE BOX, VISUAL INSPECTION OF THE LPS SHOWS NO SIGNS OF WEAR AND TEAR OR OTHER DAMAGE. AN HPS/XPS FUNCTIONAL TEST WAS PERFORMED AND UNIT FAILED THE TEST FOR LPS WILL NOT TURN ON. PROBABLE ROOT CAUSE: BASED ON FAILURE ANALYSIS REPORT, THE PROBABLE ROOT CAUSE IS UNDETERMINED

    Additional Manufacturer Narrative · 1

    THE CONSOLE WAS REPAIRED IN THE FIELD ON OCTOBER 09, 2017. RESONATOR WAS INSTALLED PER THE LAST DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY REPORTED SERVICE INFORMATION: THE CONSOLE WAS SERVICED IN THE FIELD ON OCTOBER 09, 2017. RESONATOR WAS REPLACED. ERROR 211, 235, 302, 202 WERE OBSERVED. FIELD SERVICE ENGINEER SUSPECTS THAT EITHER THE LPS AND/OR THE MASTER CONTROL BOARD NEED TO BE REPLACED. THE CONSOLE REPAIR WAS COMPLETED IN THE FIELD ON NOVEMBER 07, 2017. THE LPS WAS REPLACED AND LASER STARTED WITHOUT ERRORS. FIELD SERVICE ENGINEER DETERMINED THAT THE MASTER CONTROL BOARD DID NOT NEED TO BE REPLACED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER¿S SPECIFICATIONS. THE SUSPECTED FAULTY RESONATOR AND LPS HAVE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE REPLACED XPS RESONATOR S/N# (B)(4) WAS RECEIVED AT THE MANUFACTURE ON DECEMBER 12, 2017. THE RESONATOR WILL BE REWORKED IN HOUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POT CASE, ERROR 211 WAS NOTED. REPORTEDLY, THIS ISSUE HAPPENED SECOND TIME WITH THE SAME PATIENT. THE PROCEDURE WAS NOT COMPLETED. PATIENT OUTCOME: NO INJURY TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE PROCEDURE WAS RESCHEDULED THIRD TIME AND THE PATIENT WAS TREATED SUCCESSFULLY. "NO INJURIES" TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575025 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1