BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 2653012 · Received July 12, 2012

    Report

    Report Number
    3005099803-2012-02598
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED FIBER REVEALED APPROXIMATELY 5.0 MM OF EXPOSED GLASS TIP REMAINING. THE AIMING BEAM WAS NOT EXITING FROM THE DISTAL END OR FROM ANY OTHER LOCATION ON THE BODY OF THE FIBER INDICATING THAT THE FIBER IS BROKEN WITHIN THE CONNECTOR.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER ON (B)(6) 2012: PATIENT IDENTIFIER (B)(6). DATE OF BIRTH (B)(6) 1939. PATIENT SEX FEMALE. DEVICE LOT # - ML00000639, DEVICE EXPIRATION DATE 05/31/2015. ADD'L DEVICE: GRID LASER TYPE (HOLMIUM LASER), THERAPY DATE ((B)(6)2012), (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A LITHOTRIPSY OF STONE PROCEDURE USING A FLEXIVA 200 LASER FIBER, THE CONNECTOR WENT ON; ALTHOUGH IT APPEARED NOT TO GO ON ALL THE WAY. THE FIBER HEATED UP AND THE ENERGY WAS NO LONGER BEING EMITTED FROM THE OTHER SIDE OF THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 200 LASER FIBER WITHOUT ANY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A LITHOTRIPSY OF STONE PROCEDURE USING A FLEXIVA 200 LASER FIBER, THE CONNECTOR WENT ON; ALTHOUGH IT APPEARED NOT TO GO ON ALL THE WAY. THE FIBER HEATED UP AND THE ENERGY WAS NO LONGER BEING EMITTED FROM THE OTHER SIDE OF THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 200 LASER FIBER WITHOUT ANY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A LITHOTRIPSY OF STONE PROCEDURE USING A FLEXIVA 200 LASER FIBER, THE CONNECTOR WENT ON; ALTHOUGH IT APPEARED NOT TO GO ON ALL THE WAY. THE FIBER HEATED UP AND THE ENERGY WAS NO LONGER BEING EMITTED FROM THE OTHER SIDE OF THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 200 LASER FIBER WITHOUT ANY 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 ML00000639

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOLMIUM LASER