BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3952154 · Received July 23, 2014

    Report

    Report Number
    2937094-2014-00657
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 21, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MODERATE CHAR; THE FIBER WAS TESTED WITH HENE LASER FIXTURE, THE AIM BEAM IS VISIBLE AT THE OUTPUT WINDOW. 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 WOULD LIMIT THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE DIMINISHED VAPORIZATION WAS OBSERVED AT 334,713 JOULES. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE PROCEDURE (TURP). PATIENT OUTCOME WAS REPORTED AS ¿GOOD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431490 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 409A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other