BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 2771519 · Received October 4, 2012

    Report

    Report Number
    3005099803-2012-04498
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    July 3, 2012
    Report Date
    July 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED FIBER REVEALED APPROXIMATELY 1.0 MM OF EXPOSED GLASS TIP REMAINING. THE PATTERN ON THE TIP FACE IS CONSISTENT WITH A FRACTURE INDICATING THAT THE TIP OR PORTION OF THE TIP DETACHED. THE FIBER WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THE MANUFACTURER'S ANALYSIS REVEALED THE FIBER WAS RECOGNIZED BY THEIR 20 WATT LASER WHEN IT WAS ATTACHED. THE PROXIMAL END OF THE DEVICE WAS FUNCTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A URETEROSCOPY PROCEDURE, WHEN THE FLEXIVA 200 LASER FIBER WAS PLUGGED INTO THE LUMENIS 100 WATT LASER, THE LASER DID NOT RECOGNIZE THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 200 LASER FIBER WITHOUT COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403911 ML00000595

    Patients

    Seq Age Sex Outcome Treatment
    1 LUMENIS 100 WATT LASER