BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMISITE ENDOBRONCHIAL PROCEDURE KIT

    MDR report key: 17868009 · Received October 4, 2023

    Report

    Report Number
    17868009
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    October 14, 2022
    Report Date
    December 16, 2022
    Manufacturer
    COVIDIEN LP
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING A NAVIGATIONAL BRONCHOSCOPY IN SURGERY, A PIECE OF PLASTIC WAS NOTICED ON THE FORCEPS AFTER THE BIOPSY. THE ANGLE WAS ADJUSTED, AND NO FURTHER PLASTIC WAS FOUND IN THE FOLLOWING BIOPSIES. THIS WAS THE SECOND TIME THIS HAD OCCURRED WITH THE SAME PROVIDER PERFORMING THE TASK. THE COMPANY REP WAS NOTIFIED AND DETERMINED THAT THERE ARE A SERIES OF SENSORS RUNNING THE LENGTH OF THE EXTENDED WORKING CHANNEL WHICH ALLOWS FOR CONTINUOUS GUIDANCE, EVEN AFTER THE LOCATABLE GUIDE IS REMOVED. IF THE STRUCTURAL INTEGRITY OF THE EWC (EXTENDED WORKING CHANNEL) IS COMPROMISED, THE FIBERS CAN SHEAR OFF OF THE LUMEN OF THE CATHETER. IT WAS DETERMINED THAT IT CAN OCCUR WITH THE 180° CATHETER CURVE, MEANING THAT THE EWC IS MORE PRONE TO KINKING WHICH CAN DAMAGE THE LINING, LOOSENING AND SPLINTERING THE FIBERS. WHEN A PAIR OF BIOPSY FORCEPS ARE PASSED THROUGH A KINKED EWC, IT CAN SNAG THOSE FIBERS, DRAGGING THEM OUT ALONG WITH THE SPECIMEN. IT IS FURTHER EXACERBATED DURING A "HARD CLOSE" OF THE FORCEPS AND WHEN NAVIGATING THE TIGHT TURNS OF THE APICAL SEGMENT. AFTER THE COMPANY REP SHARED THESE OPERATOR TIPS, THERE WERE NO MORE FIBERS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627514 ILLUMISITE ENDOBRONCHIAL PROCEDURE KIT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP 522071

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA Female