BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2906920 · Received January 7, 2013

    Report

    Report Number
    2937094-2013-00020
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    July 17, 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

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. 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, AND MELTED GLASS. CAP CONDITION WOULD RESULT IN REDUCED VAPORIZATION EFFICIENCY. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. 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 DURING A PROSTATE PROCEDURE, THE LASER WAS NOT FIRING AT ABOUT 52 SECONDS INTO THE CASE AT 3,679 JOULES. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8301 AMS GREENLIGHT HPS FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2093 202J

    Patients

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