BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 17396211 · Received July 26, 2023

    Report

    Report Number
    2124215-2023-37620
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    July 13, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS FIBER WAS THOROUGHLY ANALYZED. VISUAL AND MICROSCOPIC EXAMINATION OF THE FIBER IDENTIFIED A DISTAL CIRCUMFERENTIAL FRACTURE AND THE METAL CAP EXHIBITED MILD DETRITUS ADHESION ON ITS SURFACE. THE FIBER WAS TESTED WITH HENE LASER FIXTURE WHICH FOUND NO SIGNS OF BREAKAGE ALONG LENGTH OF FIBER. THE FORWARD FIRING TEST FOR THIS DEVICE RESULTED IN AN OUTPUT WHICH WAS BELOW THE THRESHOLD FOR POTENTIAL PATIENT HARM. BASED ON REVIEW OF ALL INFORMATION AVAILABLE AND ANALYSIS RESULTS, A CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, TWENTY-EIGHT MINUTES INTO A GREENLIGHT VAPORIZATION PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA WITH A 90 GLAND VOLUME AND AFTER 120238 J OF ENERGY WERE EXPENDED, THE FIBER WAS OBSERVED TO BE FORWARD FIRING. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING A THIRD FIBER. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A GREENLIGHT VAPORIZATION PROCEDURE FOR BENIGN PROSTATIC HYPERPLASIA, A FORWARD FIRING MALFUNCTION WAS OBSERVED, THIS HAPPENED AT 28 MINUTES, 90 G OF GLAND VOLUME AND USING 120238 J. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING A THIRD FIBER. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630341 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0030352251 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 Male