BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGELED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2491209 · Received March 8, 2012

    Report

    Report Number
    2937094-2012-00275
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP WAS INTACT AND ATTACHED, AND THAT THE FIBER CAP WAS DRILLED THROUGH. THE FIBER CAP EXHIBITED DETRITUS, CHAR, DEVITRIFICATION AND MELTED GLASS. THE FIBER CAP CONDITION MAY RESULT IN A FORWARD-FIRING CONDITION OF THE SIDE-FIRING FIBER, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL SAFETY ISSUE. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION, LIKELY DUE TO TISSUE CONTACT AND/ OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, LIMITING THE PERFORMANCE OF THE FIBER. THE PRODUCT LABELING WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS THERMAL PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE FIBER TO THE MANUFACTURER AND NO DETAILS REGARDING THE PRODUCT PROBLEM EXPERIENCED WERE PROVIDED. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PT. THE MANUFACTURER WAS UNABLE TO DETERMINE THE REASON FOR THE DEVICE RETURN. THE FIBER WAS RECEIVED WITHOUT PAPERWORK, HOWEVER, UPON VISUAL EXAMINATION IT WAS DETERMINED THAT THE FIBER HAD BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGELED DELIVERY DEVICE, GREENLIGHT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2090 03H

    Patients

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