BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2974370 · Received February 19, 2013

    Report

    Report Number
    2937094-2013-00250
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 26, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 WAS FOUND TO BE DRILLED THROUGH. THE CAP WAS ALSO FOUND TO EXHIBIT DETRITUS, CHAR 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 DUE TO TISSUE CONTACT ENCOUNTERED DURING THE PROCEDURE, LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 166,058 JOULES, WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, DECREASED TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED. THE CASE WAS COMPLETED USING A SECOND FIBER WITHOUT FURTHER ISSUE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72434 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 211H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT HPS LASER SYSTEM| ACCESSORIES