BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8111347 · Received November 28, 2018

    Report

    Report Number
    3005099803-2018-61625
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    August 6, 2018
    Report Date
    November 28, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729963769
    PMA / PMN Number
    K110685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: THE FIBER WAS RETURNED BROKEN. THE FIBER MEASURED APPROXIMATELY 100 CM. THE REMAINDER OF THE FIBER INCLUDING THE DISTAL TIP WAS NOT RETURNED. 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 AND WHEN THE CHIP WAS READ ON THE LUMENIS RFID PROGRAMMER IT STATED: FLEXIVA ID 200, TREATMENT USED: 0, TREATMENTS LEFT: 1 INDICATING THAT IT WAS PROGRAMMED CORRECTLY. THE EVENT AS REPORTED WAS NOT CONFIRMED. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE ROOT CAUSE IS NO PROBLEM DETECTED. A COMPLAINT WITH A CAUSE OF NO PROBLEM DETECTED INDICATES THAT THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED. THE FIBER WAS RETURNED BROKEN. THE FIBER MEASURES APPROXIMATELY 100 CM. THE REMAINDER OF THE FIBER INCLUDING THE DISTAL TIP WAS NOT RETURNED. 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 CAUSE CODE FOR 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. THIS INCLUDES UNINTENDED INAPPROPRIATE USE OF THE DEVICE AND INCORRECT SAMPLE PREPARATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATIONS WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA ID 200 LASER FIBER WAS OPENED FOR USE IN A LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THERE WAS NO LASER ENERGY COMING OUT FROM THE LASER FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 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 FIBER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950010 FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006R8403911 0000006345 08714729963769

    Patients

    Seq Age Sex Outcome Treatment
    1