BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8130928 · Received December 4, 2018

    Report

    Report Number
    3005099803-2018-61697
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    August 7, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAPTURES THE REPORTABLE INVESTIGATION RESULT OF FIBER BROKE. INVESTIGATION RESULTS A FLEXIVA ID TRACTIP LASER FIBER WAS RETURNED FOR ANALYSIS. THE FIBER WAS RETURNED BROKEN AND KINKED. SINCE THE CUSTOMER DID NOT STATE IN THE COMPLAINT THAT THE FIBER BROKE, THE DEVICE WAS MOST LIKELY BROKEN 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 THE 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; 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 200 LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS P120 MOSES CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID TRACTIP 200 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 WHICH REVEALED THAT THE LASER FIBER WAS BROKEN AND KINKED. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971104 FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006R8403961 0000006216 08714729963844

    Patients

    Seq Age Sex Outcome Treatment
    1