BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 4093759 · Received September 16, 2014

    Report

    Report Number
    3005099803-2014-03103
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K100078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION FINDINGS OF FIBER BROKEN WITHIN THE CONNECTOR. VISUAL EXAMINATION OF THE RETURNED LASER FIBER REVEALED THAT THE EXPOSED GLASS TIP MEASURED 4.0 MM AND APPEARED UNUSED. THE INVESTIGATOR WAS UNABLE TO EXAMINE THE FIBER FACE WITHIN THE SUB MINIATURE-A (SMA) CONNECTOR BECAUSE LIGHT WAS UNABLE TO TRAVEL TO THE FIBER FACE. THIS INDICATED THAT THE FIBER IS BROKEN WITHIN THE CONNECTOR. FUNCTIONAL ANALYSIS REVEALED THAT THE ¿ATTACH LASER FIBER¿ MESSAGE CLEARED FROM THE CONSOLE AFTER ATTACHMENT INDICATING THAT THE FIBER WAS RECOGNIZED BY THE LASER UNIT. THE AIMING BEAM EXITING THE DISTAL END OF THE DEVICE WAS ROUND AND VERY WEAK WITH EFFECTIVE TRANSMISSION MEASURED 2.45%. DAMAGE WAS CAUSED TO THE DEVICE WITHOUT DIRECT PATIENT CONTACT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT A FLEXIVA LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT AND THERE WAS NO AIMING BEAM. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 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
    573645 FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403911 ML00002296

    Patients

    Seq Age Sex Outcome Treatment
    1