BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 9339077 · Received November 18, 2019

    Report

    Report Number
    2937094-2019-61526
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    November 7, 2019
    Report Date
    December 19, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE DEVICE REVEALED THE GLASS CAP HAS A CIRCUMFERENTIAL FRACTURE ON THE DISTAL SIDE OF FIBER/CAP FUSION ZONE AT THE BEVEL EDGE. THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF OUTER FLOW TUBING. THE OUTER FLOW TUBING OPEN END EXHIBITS MINOR SCRATCH MARKS, AND MILD CONTAMINATION, LIKELY BIOLOGIC. DUE TO THE OBSERVED CIRCUMFERENTIAL FRACTURE AT DISTAL SIDE, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. BASED ON THE OBSERVED CIRCUMFERENTIAL FRACTURE AT DISTAL SIDE FINDING, AN EVALUATION CONCLUSION CODE OF DESIGN INADEQUATE FOR PURPOSE OF THE DEVICE WAS ASSIGNED TO THIS INVESTIGATION. A TEMPERATURE HIGHER OR CLOSE TO EPOXY DEGRADATION TEMPERATURE NEAR THE LASER BEAM OUTPUT WINDOW MAY BE A MAJOR IMPACTING FACTOR LEADING TO EPOXY FAILURE AND SUBSEQUENT FIBER BREAKAGE. TISSUE ADHESION FROM CONSTANT AND HEAVY TISSUE CONTACT COULD BE THE MAJOR CAUSE RESULTING IN THE OBSERVED CIRCUMFERENTIAL FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE LASER PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE THE FIBER FLASHED, FORWARD FIRING AFTER 1413 JOULES USED WITH A LASER TIME EXPENDED AT 13 SEC. A SECOND FIBER WAS USED TO COMPLETE THE CASE. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LASER PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE PROCEDURE THE FIBER FLASHED, FORWARD FIRING AFTER 1413 JOULES USED WITH A LASER TIME EXPENDED AT 13 SEC. A SECOND FIBER WAS USED TO COMPLETE THE CASE. THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129521 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0023311423 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1