BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 2782101 · Received October 11, 2012

    Report

    Report Number
    3005099803-2012-04362
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Report Date
    September 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE USING A FLEXIVA 200 LASER FIBER, THE TIP OF THE FIBER BROKE OFF INSIDE THE PATIENT. THE FIBER WAS USED WITH A LUMENIS 20 WATT LASER SET AT 10 WATTS. THE LASER SETTINGS WERE 1.0 JOULE AND 10 HERTZ. THERE WERE NO COMPLICATIONS TO THE PATIENT WHO IS REPORTEDLY "FINE" POST PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING, THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 LUMENIS 20 WATT LASER