BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2481040 · Received March 2, 2012

    Report

    Report Number
    2937094-2012-00253
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    June 24, 2010
    Report Date
    September 28, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE CUSTOMERS INITIAL REPORT INDICATED DIMINISHED VAPORIZATION EFFICIENCY, WHICH IS NOT CONSIDERED A REPORTABLE ISSUE. THE FAILURE ANALYSIS DISCLOSE THAT THE FIBER CAP WAS CHARRED AND DRILLED THROUGH. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; THE CAP CONDITION COULD 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. (B)(4) - THERMAL PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER RETURNED A FIBER REPORTED AS "DIMINISHED VAPORIZATION EFFICIENCY AT 164,568 JOULES." THE CASE WAS REPORTED TO BE COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    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 NA 020H

    Patients

    Seq Age Sex Outcome Treatment
    1