BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2541092 · Received April 12, 2012

    Report

    Report Number
    2937094-2012-00375
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Date of Event
    June 1, 2011
    Report Date
    June 6, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE CUSTOMER'S INITIAL REPORT INDICATED NO REASON FOR THE FIBER RETURN, HOWEVER, IT APPEARS THAT THE FIBER WAS THE SECOND FIBER USED IN A CASE REQUIRING THREE FIBERS. FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP WAS CHARRED AND DRILLED THROUGH. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; THE CAP CONDITION WOULD ALSO RESULT IN A DIFFUSE BEAM AND/OR A FORWARD FIRING CONDITION, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL 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 PERFORMANCES OF THE FIBER. THE PRODUCT LABELING STATES THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THERE WAS NO REPORT OF INJURY AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FIBER WAS RETURNED BY THE CUSTOMER WITH NO INFORMATION AS TO THE REASON FOR THE PRODUCT RETURN. THERE WAS NO REPORT OF INJURY REPORTED WITH THE PRODUCT RETURN. THE MANUFACTURER IS FILING THIS REPORT BASED ON ANALYSIS RESULTS OF THE RETURNED DEVICE.

    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 043H

    Patients

    Seq Age Sex Outcome Treatment
    1