BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA PULSE

    MDR report key: 15666521 · Received October 25, 2022

    Report

    Report Number
    2124215-2022-42908
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    September 12, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THIS PRODUCT WAS THOROUGHLY ANALYZED IN OUR QUALITY ASSURANCE LABORATORY. VISUAL ANALYSIS OF THE RETURNED FIBER OBSERVED A FIBER BODY FRACTURE WHICH WAS MEASURED 32.9 CM FROM THE DISTAL AREA OF THE FIBER TO THE PROXIMAL END OF THE SUB MINIATURE A (SMA) CONNECTOR. THE SECOND HALF OF THE FIBER BODY CONTAINING THE EXPOSED GLASS TIP WAS NOT RETURNED THEREFORE ANALYSIS COULD NOT BE PERFORMED. DURING FUNCTIONAL TESTING THE LIGHT FROM THE SMA CONNECTOR WAS BRIGHT AND ROUND, INDICATING THAT THERE WAS NO FRACTURE WITHIN THE CONNECTOR. WHEN TESTED ON THE CONSOLE THE FIBER CONNECTED AND NO ERROR MESSAGES POPULATED. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE. DO NOT BEND FIBER AT SHARP ANGLES. VISIBLE LIGHT SEEN LEAKING FROM THE FIBER INDICATES FIBER DAMAGE. IMMEDIATELY DISCONTINUE USE IF BREAKS OR FRACTURES APPEAR IN THE LASER FIBER. THESE BREAKS OR FRACTURES MAY ALLOW UNDIRECTED EMISSION OF LASER ENERGY, RENDERING THE DISTAL TIP USELESS AND CAUSING HARM TO SURROUNDING TISSUES. THE LOT NUMBER FOR THE REPORTED FLEXIVA PULSE WAS NOT PROVIDED. A SHIP HISTORY REVIEW WAS PERFORMED AND IDENTIFIED 3 POTENTIAL LOT NUMBERS SHIPPED TO THIS CUSTOMER. THE REVIEW IDENTIFIED LOTS 27419263, 28198712 AND 8083347 AS POTENTIAL FLEXIVA PULSE LOT NUMBERS THAT WERE LIKELY PRESENT AT THE FACILITY. A DHR REVIEW FOR EACH OF THE LOT NUMBERS CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FIBER WAS RETURNED TO BOSTON SCIENTIFIC WITHOUT PROCEDURE AND DEVICE PERFORMANCE INFORMATION. ANALYSIS OF THE RETURNED FIBER FOUND THAT IT WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656506 FLEXIVA PULSE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 2130-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown