BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 2073071 · Received April 29, 2011

    Report

    Report Number
    3005099803-2011-01441
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED FIBER REVEALED THE AIMING BEAM WAS EXTREMELY WEAK INDICATING THE FIBER WAS BROKEN UNDER THE 'SUB-MINIATURE A' (SMA) CONNECTOR HOUSING. HANDLING DAMAGE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AT THE BEGINNING OF A BILATERAL URETERAL CANULAS PROCEDURE USING A FLEXIVA 200 LASER FIBER, (BOX 5), THE FIBER WORKED FOR A BRIEF PERIOD OF TIME WHEN THE PHYSICIAN STEPPED ON THE FOOT PEDAL. THERE WAS MINIMAL ENERGY BEING EMITTED FROM THE FIBER. THE RED AIMING BEAM WAS VISIBLE. LASER ENERGY FROM A 20 WATT HOLMIUM LASER SET AT 5 JOULES AND 8 HERTZ WAS BEING USED WITH THE FIBER. THE PROCEDURE WAS COMPLETED WITH A FLEXIVA 365 FIBER WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY 'FINE' POST PROCEDURE. THE EVENT, AS REPORTED, IS NOT CONSIDERED AN MDR- REPORTABLE EVENT; HOWEVER, THE RETURNED DEVICE REVEALED AN MDR-REPORTABLE MALFUNCTION.

    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 1ML0092303

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 20 WATT HOLMIUM LASER