BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 2219626 · Received August 11, 2011

    Report

    Report Number
    2937094-2011-01652
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN AMERICAN MEDICAL SYSTEMS FIELD SERVICE ENGINEER CONSULTED WITH AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT REGARDING A RESOLUTION. PER AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT, ADVISED THE AMERICAN MEDICAL SYSTEM FIELD SERVICE ENGINEER TO CHANGE THE COMMUNICATION CABLES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN AMERICAN MEDICAL SYSTEMS FIELD SERVICE ENGINEER ON (B)(6) 2011 DURING A CALL WITH AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT, THE CUSTOMER REPORTED AN INTERMITTENT ERROR MESSAGE CODE 210 WHICH OCCURRED ALMOST EVERY MONTH NOW. PER THE CUSTOMER, ALTHOUGH ERROR MESSAGE CODE 210 CAME UP DURING THE PROCEDURE, THE ERROR MESSAGE WAS ABLE TO BE CLEARED AND THE PROCEDURE WAS ABLE TO COMPLETED. THE PATIENT OUTCOME WAS NOT PROVIDED.

    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 0010-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1