BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 18244448 · Received December 1, 2023

    Report

    Report Number
    2124215-2023-68054
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 3, 2023
    Report Date
    January 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIBER WAS RETURNED AND UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY ANALYZED. PHYSICAL AND MICROSCOPIC INSPECTION IDENTIFIED A DISTAL CIRCUMFERENTIAL FRACTURE (DCF) AT THE GLASS CAP; HOWEVER, THE GLASS CAP AND METAL CAPS WERE ATTACHED TO THE FIBER. THE GLASS CAP EXHIBITED MODERATE DETRITUS ADHESION ON ITS SURFACE, INDICATIVE OF PROLONGED TISSUE CONTACTS. THE FIBER WAS FUNCTIONALLY TESTED WITH THE HELIUM-NEON (HENE) LASER FIXTURE. THE TESTING CONDUCTED DID NOT IDENTIFY A PHYSICAL/SEPARATION DUE TO BREAKAGE ALONG THE LENGTH OF THE FIBER. IT IS PROBABLE THAT THE DEBRIS ADHESION FOUND DURING ANALYSIS CONTRIBUTED TO ELEVATED TEMPERATURES NEAR THE LASER BEAM OUTPUT WINDOW. CONTINUOUSLY ELEVATED TEMPERATURE CAN LEAD TO FIBER DAMAGES, INCLUDING DISTAL CIRCUMFERENTIAL FRACTURES. BASED ON ANALYSIS RESULT, THE INTERACTION BETWEEN THE USER AND DEVICE, OR SAMPLE, CAUSED OR CONTRIBUTED TO THE OBSERVED FIBER TIP DAMAGED AND REPORTED EVENT. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO MAINTAIN A WORKING DISTANCE OF 2 MM BETWEEN THE TISSUE AND FIBER TIP DURING USE AND TO INCREASED IRRIGATION FLOW BY MEANS OF A SALINE PRESSURE BAG (SET TO 250 MMHG - 300 MMHG) TO FURTHER INCREASE LIQUID COOLING EFFECT TO REDUCE FIBER TIP DAMAGE. BASED ON THE ANALYSIS RESULTS AND INFORMATION AVAILABLE, THE FIBER TIP WAS PRESENT ON THE RETURNED FIBER, AND THERE WAS NO BREAK FOUND ALONG THE LENGTH OF THE FIBER BODY. THE REPORTED EVENT INDICATED THAT THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THEREFORE, THE IDENTIFIED DCF IS UNLIKELY TO CAUSE AND/OR CONTRIBUTE TO PATIENT HARM IF IT WERE TO RECUR. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE REPORTED EVENT OF FIBER TIP BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, AND AFTER 232807 JOULES AND 32 MINUTES OF USE, THE FIBER TIP BROKE OFF DURING USE. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER, WITH NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, AND AFTER 232807 JOULES AND 32 MINUTES OF USE, THE FIBER TIP BROKE OFF DURING USE. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER, WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504695 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0031671904 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown