BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 6049007 · Received October 21, 2016

    Report

    Report Number
    2937094-2016-01005
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    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 AND SERVICE REPAIR ON (B)(4) 2016. THE REPORTED ISSUE OF ERRORS 611, 831, 651, 660 AND 302.13 WERE CONFIRMED. VERIFIED ERROR CODES WERE BEING PRODUCED. DETECTED THAT CHILLER WAS COOLING WATER AT STARTUP, SYSTEM ENTERED FAULT STAGE AFTER WATER COOLED TO APPROXIMATELY 5.0 C. MANUALLY PUMPED IN WARM WATER, LASER WOULD START THEN AGAIN COOL WATER RESULTING IN IMMEDIATE FAULT. SUSPECT FAULTY CHILLER CASE REASSIGNED FOR FURTHER TROUBLESHOOTING AND REPAIR.

    Additional Manufacturer Narrative · 1

    SERVICE IN THE FIELD WAS PERFORMED ON (B)(6) 2016. THE CHILLER S/N (B)(4) WAS RECEIVED AT THE MANUFACTURER ON (B)(6) 2016 AND WAS SENT TO THE SUPPLIER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, ERROR CODES 611, 831, 651, 660 AND 302.13 WERE OBSERVED. BIOMEDICAL ENGINEER IN COMMUNICATION WITH SERVICE ENGINEER WAS UNABLE TO RESOLVE THE ISSUES WITH THE LASER. AN ALTERNATE LASER SYSTEM ("NOT GREENLIGHT") WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED. PATIENT/USER COMPLICATIONS: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700000 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1