BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 17993166 · Received October 23, 2023

    Report

    Report Number
    2124215-2023-58717
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 3, 2023
    Report Date
    December 26, 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, THE RETURNED FIBER UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE CONNECTOR CONE, SEGMENTS, AND TABS APPEAR IN GOOD CONDITION AND SECURED. THE CONTROL KNOB IS ATTACHED AND ALIGNED WITH FIBER AND CAN ROTATE THE FIBER. A DISTAL CIRCUMFERENTIAL FRACTURE WAS OBSERVED AT THE GLASS CAP. FUNCTIONAL TESTING WITH THE HENE (HELIUM-NEON) LASER FIXTURE DID NOT IDENTIFY BREAKS ALONG THE LENGTH OF THE FIBER. THE FIBER WAS TESTED USING THE FORWARD FIRING TEST FIXTURE, THE CALCULATED THE RATE OF FORWARD FIRING WAS BELOW THE THRESHOLD FOR POTENTIAL PATIENT HARM. 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 34 MIN OF PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) AND 222106 JOULES USED, THE FIBER STARTED TO FORWARD FIRE. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER 34 MIN OF PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) AND 222106 JOULES USED, THE FIBER STARTED TO FORWARD FIRE. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674376 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0031044051 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 Male