BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS GREENLIGT HPS FIBER

    MDR report key: 2835759 · Received October 22, 2012

    Report

    Report Number
    2937094-2012-01093
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 21, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER 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 REMAINS INTACT AND ATTACHED AND DRILLED THROUGH; EXHIBITS DETRITUS, CHAR, DEVITRIFICATION, AN 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 THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 34,561 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED BY TURP. NO PATIENT OR END USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS GREENLIGT HPS FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2093 123J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GREENLIGHT HPS LASER SYSETM AND ACCESSORIES