BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 8107757 · Received November 27, 2018

    Report

    Report Number
    3005099803-2018-61516
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    August 6, 2018
    Report Date
    November 27, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729963844
    PMA / PMN Number
    K110685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULT: VISUAL EXAMINATION REVEALED THAT THE EXPOSED GLASS FIBER TIP MEASURED APPROXIMATELY 3.0 MM AND APPEARED UNUSED. ADDITIONAL EXAMINATION UNDER MAGNIFICATION CONFIRMED THAT THE TIP WAS UNUSED. FUNCTIONAL ANALYSIS REVEALED THAT WHEN THE FIBER WAS CONNECTED TO THE LUMENIS POWERSUITE LASER CONSOLE, THE ATTACH FIBER MESSAGE DISAPPEARED INDICATING THAT THE FIBER WAS RECOGNIZED BY THE CONSOLE. THE AIMING BEAM WAS BRIGHT, CLEAR AND DUE TO THE BREAK, SCATTERED. FUNCTIONAL ANALYSIS REVEALED THAT WHEN THE CHIP WAS READ ON THE LUMENIS RFID PROGRAMMER IT STATED: FLEXIVA ID 200, TREATMENT USED: 1, TREATMENTS LEFT: 0 INDICATING THAT IT WAS PROGRAMMED CORRECTLY. THE FIBER WAS RETURNED BROKEN INTO THREE PIECES BECAUSE THE CUSTOMER ACCIDENTALLY ROLLED OVER THE FIBER WITH HER OFFICE CHAIR. THE FIRST PIECE MEASURED APPROXIMATELY 104.5 CM FROM THE TOP OF THE CONNECTOR TO THE BREAK. THE SECOND PIECE MEASURED APPROXIMATELY 118.3 FROM BREAK TO BREAK AND WAS KINKED. THE THIRD PIECE MEASURED APPROXIMATELY 102.5 FROM THE BREAK WHICH INCLUDES THE ENTIRE DISTAL TIP AND WAS KINKED. THEREFORE, THE CAUSE CODE ASSIGNED TO THIS EVENT IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT WHICH INDICATES THAT THE INTERACTION BETWEEN THE USER AND DEVICE, OR SAMPLE, CAUSED OR CONTRIBUTED TO THE ERROR. THE COMPLAINT AS REPORTED CANNOT BE CONFIRMED BECAUSE THE FIBER WAS RETURNED BROKEN, AS A RESULT, LASER ENERGY COULD NOT BE PASSED THROUGH THE FIBER. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A COMPLAINT WITH A CAUSE OF ADVERSE EVENT RELATED TO PROCEDURE INDICATES THAT THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA ID TRACTIP LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS LUMENIS 120 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS NO LASER ENERGY COMING OUT FROM THE LASER FIBER. REPORTEDLY, WHILE THE LASER FIBER WAS PACKED FOR RETURN THE CUSTOMER ACCIDENTALLY ROLLED OVER THE FIBER WITH HER OFFICE CHAIR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP LASER FIBER. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS AND ADDITIONAL INFORMATION RECEIVED WHICH REVEALED THAT THE LASER FIBER WAS BROKEN. PLEASE REFER TO FOR FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948165 FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006R8403961 0000006153 08714729963844

    Patients

    Seq Age Sex Outcome Treatment
    1