BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2553750 · Received April 25, 2012

    Report

    Report Number
    2937094-2012-00431
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    August 8, 2011
    Report Date
    October 24, 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
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND ANALYZED. THE CUSTOMERS INITIAL REPORT INDICATED DIMINISHED 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 DIMINISHED VAPORIZATION AT 44,490 JOULES. THE CASE WAS COMPLETED WITH A SECOND FIBER. THERE WAS NO PT INJURY.

    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 946U

    Patients

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