BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2865413 · Received October 22, 2012

    Report

    Report Number
    2937094-2012-01098
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 14, 2011
    Report Date
    September 27, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER ASSIGNED MODEL NUMBER 0010-2093 IS DESIGNATED FOR (B)(4) DISTRIBUTION. THE MANUFACTURER IS SUBMITTING THIS REPORT AS THE MODEL 0010-2093 IS IDENTICAL IN DESIGN AND MANUFACTURE TOT HE COMMERCIALLY AVAILABLE MODEL 0010-2090 ANGLED DELIVERY DEVICE, GREENLIGHT (K062719). FIBER ANALYSIS: THE FIBER CAP REMAINS INTACT AND ATTACHED AND DRILLED THROUGH; EXHIBITS DETRITUS, CHAR, DEVITRIFICATION, AND MELTED GLASS. CAP CONDITION WOULD RESULT IN REDUCED VAPORIZATION EFFICIENCY. THIS MAY CAUSE FORWARD FIRING. 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, LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF THE CASE, THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 300,000 JOULES DURING A PROSTATE PROCEDURE. AN ADDITIONAL FIBER WAS NOT USED TO COMPLETE THE CASE. NO PATIENT OR END USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS GREENLIGHT HPS FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2093 120J

    Patients

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