BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 17131967 · Received June 14, 2023

    Report

    Report Number
    2124215-2023-30488
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 9, 2023
    Report Date
    August 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED FIBER BREAK IS CONFIRMED. ANALYSIS OF THE RETURNED FIBER IDENTIFIED TWO FIBER BODY BREAKS. THE FIRST ONE WAS OBSERVED BETWEEN THE INPUT CONNECTOR AND CONTROL KNOB. THE SECOND FIBER BODY BREAK WAS OBSERVED AT THE OPEN END OF THE METAL CAP. THE BROKEN ENDS OF THE FIBER BODY EXHIBITED BURN MARKS. THE FIBER WAS FUNCTIONALLY TESTED WITH THE HENE (HELIUM-NEON) LASER FIXTURE. THE TESTING CONDUCTED IDENTIFIED MOST OF THE OUTPUT ESCAPES FROM THE FRACTURE LOCATION. THE IFU STATES: DO NOT PRESS THE FIBER END INTO THE TISSUE, WHICH WILL CREATE STRESS BETWEEN THE FIBER AND THE OPENING (EDGE) OF THE CYSTOSCOPE. DAMAGE TO THE FIBER MAY RESULT. DO NOT BEND THE FIBER AT SHARP ANGLES. DAMAGE MAY OCCUR TO THE FIBER. THE FIBER IS A PRECISION DEVICE. DAMAGE TO THE FIBER CAN RESULT IN THE EMISSION OF UNCONTROLLED LASER ENERGY. DO NOT EXCESSIVELY MANIPULATE OR BEND THE FIBER. BASED ON ANALYSIS RESULT, IT IS LIKELY THAT PROCEDURAL HANDLING OF THE DEVICE DURING SET-UP AND USE SUCH AS EXCESSIVE MANIPULATION/ROUGH TECHNIQUE CONTRIBUTED TO THE FIBER BODY BREAK. A CONCLUSION CODE OF UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIBER BROKE, AND THE NONWOVENS FABRIC PAD BURNT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE FIBER BROKE. AND THE NONWOVENS FABRIC PAD BURNT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946196 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 0010-2400 0029896820 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male