BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 1972275 · Received January 28, 2011

    Report

    Report Number
    3005099803-2011-00086
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED FIBER REVEALED 0.2 MM OF EXPOSED TIP REMAINING. FOLLOWING REMOVAL OF 20 MM OF JACKETING FROM THE DISTAL TIP REVEALED A CLEAN BREAK ON THE FIBER TIP. THE PATTERN ON THE TIP FACE CONFIRMED FIBER DEGRADATION AND FIBER FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A BLADDER STONE PROCEDURE USING A FLEXIVA 1000 LASER FIBER, THE TIP OF THE FIBER FELL INSIDE THE PATIENT LEAVING PIECES OF GLASS IN THE BLADDER. THE PHYSICIAN WAS ABLE TO REMOVE THE PIECES OF GLASS AND TIP OF THE FIBER WITH GRASPERS. LASER ENERGY FROM A 100 WATT LUMENIS LASER SET AT 1.0 JOULES AND 50 HERTZ WAS BEING USED WITH THE FIBER.THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER, WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A BLADDER STONE PROCEDURE USING A FLEXIVA 1000 LASER FIBER, THE TIP OF THE FIBER FELL INSIDE THE PATIENT LEAVING PIECES OF GLASS IN THE BLADDER. THE PHYSICIAN WAS ABLE TO REMOVE THE PIECES OF GLASS AND TIP OF THE FIBER WITH GRASPERS. LASER ENERGY FROM A 100 WATT LUMENIS LASER SET AT 1.0 JOULES AND 50 HERTZ WAS BEING USED WITH THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER, WITHOUT ANY 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 M0068403941 1ML0072605

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention LUMENIS 100 WATT LASER