BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2227538 · Received August 15, 2011

    Report

    Report Number
    2937094-2011-01711
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) ON (B)(6) 2011 ERROR MESSAGE CODES OCCURRED DURING A PROCEDURE. DURING THE PROCEDURE, RIGHT AFTER TURNING ON THE KEY SWITCH, THE CUSTOMER RECEIVED AN ERROR MESSAGE CODE 410. THE LASER SYSTEM WENT INTO THE USUAL SELF SCREENING MODE FOR ABOUT FIVE MINUTES. THEN IN ABOUT TEN MINUTES AFTER INITIAL FIBER LASING THREE ERROR MESSAGE CODES WERE RECEIVED, ERROR MESSAGE CODES 171, 410 AND 210. THE LASER SYSTEM WENT INTO SAFETY SHUTDOWN MODE. PER THE CUSTOMER, ONCE THE LASER SYSTEM CAME BACK UP, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO FURTHER ISSUES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-0077 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other