BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 18222537 · Received November 28, 2023

    Report

    Report Number
    2124215-2023-67282
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    October 18, 2023
    Report Date
    February 8, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THE RETURNED FIBER UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE GLASS CAP WAS DETACHED AND NOT RETURNED WITH THE DEVICE. THE METAL CAP EXHIBITED DEBRIS ADHESION ON ITS SURFACE, INDICATIVE OF TISSUE CONTACT. FUNCTIONAL TESTING WITH THE HENE (HELIUM-NEON) LASER FIXTURE DID NOT IDENTIFY BREAKS ALONG THE LENGTH OF THE FIBER. THE CONNECTOR CONE, SEGMENTS, AND TABS APPEAR IN GOOD CONDITION AND SECURED. THE FIBER WAS TESTED USING THE FORWARD FIRING TEST FIXTURE, AND THE CALCULATED RATE OF FORWARD FIRING WAS ABOVE THE THRESHOLD FOR POTENTIAL PATIENT HARM. IT IS PROBABLE THAT THE TISSUE ADHESION FOUND AT THE METAL CAP DURING ANALYSIS CONTRIBUTED TO ELEVATED TEMPERATURES NEAR THE LASER BEAM OUTPUT WINDOW. CONTINUOUSLY ELEVATED TEMPERATURES CAN LEAD TO FIBER DAMAGES, INCLUDING GLASS CAP DETACHMENT. THE DEVICE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER 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 ANALYSIS RESULT, THE INTERACTION BETWEEN THE USER AND DEVICE CAUSED OR CONTRIBUTED TO THE OBSERVED FIBER DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER 15MIN AND 160 J OF USE THE INNER PART OF THE FIBER DID NOT ROTATE TOGETHER WITH THE EXTERNAL ONE AND THERE WAS AN INTERNAL FRACTURE. ANOTHER FIBER WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER 15MIN AND 160 J OF USE THE INNER PART OF THE FIBER DID NOT ROTATE TOGETHER WITH THE EXTERNAL ONE AND THERE WAS AN INTERNAL FRACTURE. ANOTHER FIBER WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523969 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0031326091 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown