BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3101542 · Received May 3, 2013

    Report

    Report Number
    2937094-2013-00541
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 26, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIBER ANALYSIS: THE FIBER CAP WAS FOUND TO BE ATTACHED AND INTACT, HOWEVER, MELTED AT THE BEVELED SECTION AND DRILLED THROUGH. THE CAP WAS ALSO FOUND TO EXHIBIT DETRITUS AND DEVITRIFICATION. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; LIKELY RESULTING IN A DIFFUSE BEAM AND REDUCED TISSUE VAPORIZATION EFFICIENCY. THE DRILLED THROUGH FIBER CAP CONDITION MAY ALSO RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION/USER HANDLING DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER TIP WAS DAMAGED AT 32,641 JOULES OF USE; THE CASE WAS CONTINUED USING A SECOND FIBER, WHICH WAS REPLACED DUE TO AN UNSPECIFIED FAILURE, AND THE CASE CONTINUED USING A THIRD FIBER. WHILE USING THE THIRD SURGICAL FIBER, THE TIP WAS DAMAGE AT 17,816 JOULES OF USE. THE CASE WAS COMPLETED USING A FOURTH FIBER. THERE WAS NO INJURY REPORTED. THIS REPORT IS FOR THE SECOND SURGICAL FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194219 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 251H

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability