BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 5354344 · Received January 8, 2016

    Report

    Report Number
    3005099803-2015-03850
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 17, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2015 THAT A FLEXIVA 1000 LASER FIBER WAS USED DURING A LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2015. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 120W WITH .4J X 50HZ SETTINGS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE DETACHED FRAGMENT WITH GRASPERS. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12885 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403941 C000002187

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention