BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2913104 · Received January 8, 2013

    Report

    Report Number
    2937094-2013-00035
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    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 THE 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 NOTICED TO HAVE DIMINISHED VAPORIZATION EFFICIENCY AT 68,083 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A TURP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9260 AMS GREENLIGHT HPS FIBER POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2093 202J

    Patients

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