BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 18911633 · Received March 15, 2024

    Report

    Report Number
    2124215-2024-15748
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 23, 2024
    Report Date
    May 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    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 POST MARKET QUALITY ASSURANCE LABORATORY, THIS FIBER WAS THOROUGHLY ANALYZED. VISUAL INSPECTION CONFIRMED THAT THE CONNECTOR CONE, SEGMENTS, AND TABS WERE IN GOOD CONDITION. THE CONTROL KNOB IS ATTACHED AND ALIGNED WITH THE FIBER AND CAN ROTATE THE FIBER. THE HENE (HELIUM-NEON) TEST FOUND NO BREAKS ALONG THE FIBER LENGTH. UPON MICROSCOPIC INSPECTION IT WAS IDENTIFIED THAT THE GLASS CAP EXHIBITED A DISTAL CIRCUMFERENTIAL FRACTURE WITH MILD LEVEL OF DEBRIS ADHESION. THE FORWARD FIRING TEST FOR THIS DEVICE RESULTED IN AN OUTPUT WHICH IS BELOW THE THRESHOLD FOR POTENTIAL PATIENT HARM, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP), AFTER 181375 J USED AND 19 MIN OF TREATMENT, THE DEVICE WAS FORWARD FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE, AFTER 181375 J USED AND 19 MIN OF TREATMENT, THE DEVICE WAS FORWARD FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754774 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0032292924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male