BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2974399 · Received February 19, 2013

    Report

    Report Number
    2937094-2013-00254
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 12, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 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 DURING A PROSTATE PROCEDURE, THE TIP OF THE SURGICAL FIBER WAS OBSERVED TO BE DAMAGED AT 160,043 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72881 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 220H

    Patients

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