BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA ID TRACTIP

    MDR report key: 8130852 · Received December 4, 2018

    Report

    Report Number
    3005099803-2018-61696
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    August 8, 2018
    Report Date
    December 4, 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). CAPTURES THE REPORTABLE INVESTIGATION RESULT OF FIBER BROKE. INVESTIGATION RESULTS: A FLEXIVA LASER FIBER WAS RECEIVED FOR ANALYSIS. THE FIBER WAS RETURNED BROKEN. SINCE THE CUSTOMER DID NOT STATE THAT THE FIBER WAS BROKEN DURING THE PROCEDURE, THE FIBER MOST LIKELY BROKE WHILE PACKAGING FOR RETURN. THEREFORE, THE MOST PROBABLE CAUSE OF THE BROKEN FIBER 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. THIS INCLUDES UNINTENDED INAPPROPRIATE USE OF THE DEVICE AND INCORRECT SAMPLE PREPARATION. FUNCTIONAL ANALYSIS REVEALED THAT WHEN THE FIBER WAS CONNECTED TO A LUMENIS POWERSUITE LASER CONSOLE, THE "ATTACH FIBER" MESSAGE DISAPPEARED INDICATING THAT THE FIBER WAS RECOGNIZED BY THE CONSOLE. ADDITIONAL ANALYSIS REVEALED THAT WHEN THE CHIP WAS READ ON THE LUMENIS RFID PROGRAMMER IT STATED: FLEXIVA ID 200 TRACTIP, SESSION TYPE: 1, SESSION LIMIT GRACE: 0 INDICATING THAT IT WAS PROGRAMMED CORRECTLY. THE CONDITION OF THE RETURNED DEVICE DOES NOT CONFIRM THE REPORTED EVENT OF THE FIBER NOT RECOGNIZED BY THE CONSOLE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT IS NO PROBLEM DETECTED, WHICH INDICATES THAT THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATIONS WERE FOUND.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO FLEXIVA ID TRACTIP 200 LASER FIBERS USED IN THE SAME PROCEDURE. PLEASE SEE MFR REPORT # 3005099803-2018-61696 AND MFR REPORT # 3005099803-2018-61700 FOR THE RELEVANT REPORT INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018, THAT TWO FLEXIVA ID TRACTIP 200 LASER FIBERS WERE USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 120 WATT CONSOLE WITH LASER SETTINGS OF 0.2 JOULES AND 60 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT (CAPTURED BY THIS REPORTED). A SECOND FLEXIVA ID TRACTIP 200 LASER FIBER WAS USED HOWEVER, IT STOPPED WORKING (CAPTURED BY MFR REPORT # 3005099803-2018-61700). THE PROCEDURE WAS COMPLETED WITH THE THIRD FLEXIVA ID TRACTIP 200 LASER FIBER. THERE WERE NO SERIOUS INJURY NOT ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER WAS BROKEN. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970989 FLEXIVA ID TRACTIP POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006R8403961 0000006247 08714729963844

    Patients

    Seq Age Sex Outcome Treatment
    1