BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2865330 · Received October 22, 2012

    Report

    Report Number
    2937094-2012-01113
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 27, 2011
    Report Date
    November 30, 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

    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 MFR TO THE COMMERCIALLY AVAILABLE MODEL 0010-2090 ANGLED DELIVERY DEVICE, GREENLIGHT (K062719). FIBER ANALYSIS: THE FIBER CAP WAS FOUND TO BE DETACHED; THE FIBER WAS BROKEN PROXIMAL TO GLUE ZONE. THE FIBER CAP WAS NOT RETURNED BY THE CUSTOMER. THE FIBER/CAP CONDITIONS WOULD RESULT IN FORWARD FIRING. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION, LIKELY DUE TO TISSUE CONTACT AND OR AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, RESULTING IN CAP DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER TIP BURNED AT 246,929 JOULES DURING A PROSTATE PROCEDURE. THERE WAS NO REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PT 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 122J

    Patients

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