BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 2854076 · Received December 3, 2012

    Report

    Report Number
    3005099803-2012-05358
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 8, 2012
    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

    VISUAL ANALYSIS OF THE RETURNED FIBER REVEALED THERE IS NO EXPOSED GLASS TIP REMAINING. THE PATTERN ON THE TIP FACE IS CONSISTENT WITH NORMAL USE INDICATING THE FIBER DEGRADED DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT LESS THAN FOUR MINUTES INTO THE BLADDER STONE PROCEDURE, THE TIP OF THE FLEXIVA 1000 LASER FIBER BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED. THE DEVICE USED TO RETRIEVE THE FIBER TIP IS UNKNOWN. LASER TYPE AND LASER SETTINGS ARE UNKNOWN. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE 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 LESS THAN FOUR MINUTES INTO THE BLADDER STONE PROCEDURE, THE TIP OF THE FLEXIVA 1000 LASER FIBER BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED. THE DEVICE USED TO RETRIEVE THE FIBER TIP IS UNKNOWN. LASER TYPE AND LASER SETTINGS ARE UNKNOWN. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE 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 M0068403941 ML00000814

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention