BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7303335 · Received February 28, 2018

    Report

    Report Number
    3005099803-2018-00511
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 2, 2018
    Report Date
    February 7, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    UDI-DI
    08714729802716
    PMA / PMN Number
    K110686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE ACCUTRAC 200 LASER FIBER WAS RECEIVED FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE EXPOSED GLASS FIBER TIP MEASURED APPROXIMATELY 3.5 MM AND APPEARED USED. ADDITIONAL EXAMINATION UNDER MAGNIFICATION REVEALED THAT THE FIBER TIP WAS SLIGHTLY DEGRADED. THE FIBER TIP WAS INTACT AND WAS NOT DETACHED. THE FIBER WAS RETURNED BROKEN INTO TWO PIECES. THE FIRST PIECE MEASURED APPROXIMATELY 232 CM FROM THE TOP OF THE CONNECTOR TO THE BREAK. THE SECOND PIECE MEASURED APPROXIMATELY 85 CM FROM THE BREAK WHICH INCLUDES THE ENTIRE DISTAL TIP. THERE WAS A BURN MARK AT THE BREAK INDICATING THAT THE FIBER BROKE WHILE ENERGY WAS BEING APPLIED. FUNCTIONAL ANALYSIS REVEALED THAT THE AIMING BEAM EXITING THE BREAK WAS BRIGHT, CLEAR AND SCATTERED AS A RESULT OF THE BREAK. THE AIMING BEAM WOULD NOT BE VISIBLE FROM THE DISTAL END OF THE DEVICE WHEN THE FIBER BREAKS WHILE IN USE THEREBY CONFIRMING THE EVENT OF AIMING BEAM NOT VISIBLE/WEAK. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE ROOT CAUSE IS SUPPLIER MANUFACTURING EXECUTION ERROR. THE PRODUCT LIKELY FAILED TO MEET THE SPECIFICATIONS DUE TO THE MANUFACTURING PROCESS AT THE SUPPLIER SITE. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN ACCUTRAC 200 LASER FIBER WAS USED DURING A URS PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS GYRUS ACMI CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LASER FIBER WAS USED AND SUDDENLY THE AIMING BEAM WAS NO LONGER VISIBLE. THE FIBER WAS REMOVED FROM THE SCOPE AND IT WAS NOTED THAT THE TIP HAD DETACHED AND REMAINED IN THE SCOPE. THE SCOPE AND THE FRAGMENT WERE REMOVED FROM THE PATIENT TOGETHER. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO SERIOUS INJURY REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MFG. SITE NAME-COHERENT INC. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 07, 2018 THAT AN ACCUTRAC 200 LASER FIBER WAS USED DURING A URS PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS GYRUS ACMI CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LASER FIBER WAS USED AND SUDDENLY THE AIMING BEAM WAS NO LONGER VISIBLE. THE FIBER WAS REMOVED FROM THE SCOPE AND IT WAS NOTED THAT THE TIP HAD DETACHED AND REMAINED IN THE SCOPE. THE SCOPE AND THE FRAGMENT WERE REMOVED FROM THE PATIENT TOGETHER. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACCUTRAC 200 LASER FIBER. THERE WERE NO SERIOUS INJURY REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146520 ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068404110 0000005252 08714729802716

    Patients

    Seq Age Sex Outcome Treatment
    1