BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGH HPS FIBER

    MDR report key: 2996329 · Received February 12, 2013

    Report

    Report Number
    2937094-2013-00193
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    November 9, 2012
    Report Date
    January 16, 2013
    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

    THE MFR ASSIGNED MODEL NUMBER 0010-2093 IS DESIGNATED FOR (B)(4) 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 INTACT AND ATTACHED; EXHIBITS A DRILLED THROUGH CONDITION. THE FIBER CAP WAS ALSO FOUND TO EXHIBIT DETRITUS, CHAR, DEVITRIFICATION AND MELTED GLASS. THE FIBER CAP CONDITION WOULD RESULT IN REDUCED VAPORIZATION EFFICIENCY. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. THE MOST PROBABLE CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE RELATED TO LOCALIZED HEAT ACCUMULATION/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 4620 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PT OR END USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61906 AMS GREENLIGH HPS FIBER POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2093 222J

    Patients

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