BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3040487 · Received April 3, 2013

    Report

    Report Number
    2937094-2013-00410
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER CAP REMAINS INTACT AND ATTACHED; EXHIBITS A DRILLED THROUGH CONDITION. THE FIBER CAP SHOWS BENDING AT THE CAP OPEN END. THE FIBER CAP REGION EXHIBITS DEVITRIFICATION AND MELTED GLASS. THE FIBER SHOWS SEVERE BURNT DETRITUS; FIBER SHRINK TUBE AND FIBER JACKET ARE MELTED. 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 COULD ALSO RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THE FAILURE IS SUSPECTED TO BE HEAT ACCUMULATION / USER HANDLING DUE TO 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 THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, SIGNIFICANTLY DIMINISHED TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED AT 90,808 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136246 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 228H

    Patients

    Seq Age Sex Outcome Treatment
    1