BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2913105 · Received January 8, 2013

    Report

    Report Number
    2937094-2013-00036
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    July 2, 2012
    Report Date
    September 18, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFR ASSIGNED MODEL NUMBER 0010-2093 IS DESIGNATED FOR JAPAN DISTRIBUTION. THIS REPORT IS BEING SUBMITTED AS A MODEL 0010-2093, IS IDENTICAL IN DESIGN AND MANUFACTURE TO THE COMMERCIALLY AVAILABLE MODEL 0010-2090. ANGLED DELIVERY DEVICE, GREENLIGHT (K062719). FIBER ANALYSIS: THE FIBER CAP WAS FOUND TO BE DRILLED THROUGH. THE CAP WAS ALSO FOUND TO EXHIBIT DETRITUS, CHAR AND DEVITRIFICATION. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; LIKELY RESULTING IN A DIFFUSED BEAM AND REDUCED TISSUE VAPORIZATION EFFICIENCY. THE DRILLED THROUGH CAP MAY ALSO RESULT IN A FORWARD FIRING CONDITION OF THE SIDE FIRING FIBER. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE-FIRING FIBER WAS NOT EMITTING A BEAM AFTER 30,000 JOULES OF USE DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10278 AMS GREENLIGHT HPS FIBER POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2093 148J

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT HPS LASER SYSTEM AND| ACCESSORIES