BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 2221797 · Received August 24, 2011

    Report

    Report Number
    3005099803-2011-02904
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT IS REPORTED TO BE OVER 18 YEARS OF AGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT WAS ADMITTED FOR A CYSTOSCOPY PROCEDURE, CLOT EVALUATION AND A FULGURATION LASER LITHOTRIPSY PROCEDURE. THERE WAS A SIGNIFICANT STONE BURDEN OF APPROXIMATELY SIX STONES BETWEEN ONE TO TWO CM IN DIAMETER. THE PHYSICIAN USED A FLEXIVA 1000 MICRON FIBER. THE PATIENT RETURNED TO THE EMERGENCY ROOM LATER THAT DAY WITH BLOOD IN THE FOLEY CATHETER. THE PHYSICIAN PERFORMED A GREEN LIGHT LASER TRANSURETHRAL RESECTION OF THE PROSTATE AT THAT TIME. DURING THE PROCEDURE, THE PHYSICIAN IDENTIFIED A 4 MM FRAGMENT OF LASER FIBER IN THE PATIENT'S BLADDER. THE SURGEON WAS ABLE TO REMOVE THE PIECE OF FIBER FROM THE PATIENT USING ALLIGATOR FORCEPS. USING THE GREENLIGHT XPS LASER, THE ADENOMATOUS TISSUE WAS VAPORIZED USING POWER RANGING FROM 80 KILOJOULES TO 180 KILOJOULES FOR A TOTAL ENERGY USAGE OF 4012 JOULES. THE HOLMIUM LASER WAS SET AT ENERGY OF 3. THE GREENLIGHT XPS LASER WAS USED FOR THE TRANSURETHRAL RESECTION PROSTATE AND THE HOLMIUM LASER WAS USED FOR THE FULGURATION LASER LITHOTRIPSY PROCEDURE. THE PATIENT'S CONDITION IMPROVED AND THE PATIENT WAS DISCHARGED. ADDITIONAL FOLLOW-UP FROM THE CUSTOMER STATED THAT THE PHYSICIAN CONFIRMED THE HEMATURIA AND RESULTING TURP WERE UNRELATED TO THE FIBER PROCEDURE. THE PATIENT HAD PROSTATIC ADENOMATOUS TISSUE THAT CAUSED THE BLEEDING WHICH REQUIRED THE TURP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT WAS ADMITTED FOR A CYSTOSCOPY PROCEDURE, CLOT EVALUATION AND A FULGURATION LASER LITHOTRIPSY PROCEDURE. THERE WAS A SIGNIFICANT STONE BURDEN OF APPROXIMATELY SIX STONES BETWEEN ONE TO TWO CM IN DIAMETER. THE PHYSICIAN USED A FLEXIVA 1000 MICRON FIBER. THE PATIENT RETURNED TO THE EMERGENCY ROOM LATER THAT DAY WITH BLOOD IN THE FOLEY CATHETER. THE PHYSICIAN PERFORMED A GREEN LIGHT LASER TRANSURETHRAL RESECTION OF THE PROSTATE AT THAT TIME. DURING THE PROCEDURE, THE PHYSICIAN IDENTIFIED A 4 MM FRAGMENT OF LASER FIBER IN THE PATIENT'S BLADDER. THE SURGEON WAS ABLE TO REMOVE THE PIECE OF FIBER FROM THE PATIENT USING ALLIGATOR FORCEPS. USING THE GREENLIGHT XPS LASER, THE ADENOMATOUS TISSUE WAS VAPORIZED USING POWER RANGING FROM 80 KILOJOULES TO 180 KILOJOULES FOR A TOTAL ENERGY USAGE OF 4012 JOULES. THE HOLMIUM LASER WAS SET AT ENERGY OF 3. THE GREENLIGHT XPS LASER WAS USED FOR THE TRANSURETHRAL RESECTION PROSTATE AND THE HOLMIUM LASER WAS USED FOR THE FULGURATION LASER LITHOTRIPSY PROCEDURE. THE PATIENT'S CONDITION IMPROVED AND THE PATIENT WAS DISCHARGED.

    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 M0068403940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HOLMIUM LASER