BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2553748 · Received April 25, 2012

    Report

    Report Number
    2937094-2012-00433
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    October 13, 2011
    Report Date
    October 15, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND ANALYZED. THE CUSTOMER INITIAL REPORT INDICATED A DECREASE IN FIBER VAPORIZATION, WHICH IS NOT CONSIDERED A REPORTABLE ISSUE. UPON ANALYSIS OF THE RETURNED FIBER, THE FIBER CAP WAS FOUND TO BE CHARRED AND DRILLED THROUGH. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; THE CAP CONDITIONS WOULD ALSO RESULT IN A DIFFUSE BEAM AND OR A FORWARD FIRING CONDITION, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL RISK AND SAFETY ISSUE. 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. THE PRODUCT LABELING STATES THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SIGNIFICANTLY DIMINISHED FIBER VAPORIZATION AND THEN THE FIBER STOPPED FIRING AT 75,539 JOULES. THE CASE WAS COMPLETED WITH A SECOND FIBER. THE PT OUTCOME WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-2090 048H

    Patients

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