BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 3173558 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05226
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K110685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF FIBER BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIVA 200 TRACTIP LASER FIBER WAS USED DURING A STONE MANIPULATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE TIP OF THE FIBER BROKE. THERE WAS NO PART OF THE DEVICE THAT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 200 TRACTIP LASER FIBER WITHOUT COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274451 FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403960 ML00001238

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR