BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 2231861 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-03053
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    May 25, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).VISUAL ANALYSIS OF THE RETURNED FIBER REVEALED 0.5MM OF EXPOSED TIP REMAINING. THE PATTERN ON THE TIP FACE CONFIRMED FIBER FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A URETHRAL AND BLADDER CALCULUS PROCEDURE USING A FLEXIVA 500 LASER FIBER, THE FIBER DEGRADED DURING USE. LASER ENERGY FROM A HOLMIUM LASER SET AT 2.4 KILOJOULES WAS BEING USED WITH THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 500 LASER FIBER, WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE POST PROCEDURE. THE EVENT, AS REPORTED, DOES NOT CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THE RETURNED DEVICE REVEALED AN MDR REPORTABLE EVENT. ADDITIONALLY, FOLLOW UP FROM THE CUSTOMER CONFIRMED THE REPORTABLE EVENT. ADDITIONAL INFORMATION FROM THE CUSTOMER STATED THAT THE TIP OF THE DEVICE DETACHED INSIDE THE PATIENT AND WAS REMOVED USING AN UNKNOWN DEVICE.

    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 M0068403931 ML0121307

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention HOLMIUM LASER