BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3910816 · Received July 2, 2014

    Report

    Report Number
    2937094-2014-00567
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INDICATED THIS MDR MANUFACTURER REPORT NUMBER IS A DUPLICATE OF 2937094-2014-00522.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITED MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITED MODERATE BURNT ON DETRITUS; THE OUTER FLOW TUBING EXHIBITED MILD CONTAMINATION, LIKELY BIOLOGIC. BASED ON THE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY ALSO EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION. CAP WEAR WAS ACCELERATED DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    THREE SURGICAL FIBERS WERE REPORTED TO HAVE BEEN USED DURING A GREENLIGHT BPH PROCEDURE OF A LARGE, APPROXIMATELY 200 G, PROSTATE. AT 29,028 JOULES WHILE USING THE FIRST SURGICAL FIBER, PROSTATIC CALCIFICATIONS/STONES WERE ENCOUNTERED RESULTING IN FIBER DAMAGE AND FORWARD-FIRING OF THE OUTPUT BEAM. THE FIBER WAS EXCHANGED AND THE CASE CONTINUED USING THE SECOND FIBER, WHICH WAS REPORTED ALSO TO HAVE FAILED AT A LOW JOULE COUNT. THE PROCEDURE WAS COMPLETED USING A THIRD SURGICAL FIBER. THE PROCEDURE OUTCOME WAS REPORTED AS "OK" - NO PATIENT INJURY WAS REPORTED. THIS REPORT IS FOR THE FIRST SURGICAL FIBER USED. TIME EXPENDED: 6:27.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386359 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 405A

    Patients

    Seq Age Sex Outcome Treatment
    1