BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RBI2 SUCTION RECTAL BIOPSY SYSTEM

    MDR report key: 20923370 · Received December 13, 2024

    Report

    Report Number
    3005921952-2024-00004
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    October 23, 2024
    Report Date
    December 11, 2024
    Manufacturer
    AUS SYSTEMS PTY LTD
    Product Code
    FCK
    UDI-DI
    00+B194CP12001
    PMA / PMN Number
    K062159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMPARISON OF BLADE SIMULATION IN THE SAME POSITION AS RETURNED TIP ONLY. POSITION MATCHES RETURNED SETTING, SHOWING CONTACT WITH THE CUTTING BOARD BUT CUTTING BOARD NOT FULLY CUT. THE RETURNED CAPSULE SHOWS EVIDENCE OF JAMMED TISSUE AT THE POINT OF THE CUTTING BOARD AND THE MIDDLE OF THE BLADE. THE BLADE WAS NOT FULLY ACTIVATED DURING INITIAL USE AND STOPPED AT THE FIRST RESISTANCE. UPON MANUAL ACTIVATION, THE BLADE FIRED CORRECTLY INTO ITS FINAL POSITION, AND THE CAPSULE SNAPPED AS EXPECTED. PICTURES CONFIRMED THE BLADE, ONCE FULLY ACTIVATED, RELEASED THE JAMMED TISSUE. SIMULATIONS SHOWED PROPER FUNCTIONING OF THE BLADE AND CUTTING BOARD WHEN FULLY ACTIVATED, RULING OUT MANUFACTURING FAULTS. THIS JAMMING PREVENTED PROPER TISSUE ACTIVATION BY THE CUTTING MECHANISM. ISSUE LINKED TO INCOMPLETE BLADE ACTIVATION AND IMPROPER INTERACTION WITH THE CUTTING BOARD. THIS CAUSED A FAILURE TO ACHIEVE A CLEAN CUT AND RELEASE OF THE SPECIMEN THE ROOT CAUSE OF THE ISSUE WAS THE BLADE FAILING TO FULLY ACTIVATE DURING USE, LEADING TO TISSUE JAMMING. THIS FINDING IS CONCLUSIVE AND BEYOND DOUBT, WITH NO ADDITIONAL DEFECTS NOTED IN THE CAPSULE OR CUTTING MECHANISM UPON FURTHER ANALYSIS.

    Description of Event or Problem · 0

    "WE DID CONFIRM WITH A DRY RUN THAT THE BLADE WOULD DEPLOY WHEN FIRED, HOWEVER WHEN ATTEMPTING TO GET A SPECIMEN EVEN AFTER THIS WE WERE UNABLE TO GET A BIOPSY SPECIMEN. WE SWITCHED THE GUN TO SUCTION RECTAL BIOPSY GUN # 4 AND STILL HAD THE SAME ISSUE UNTIL ABOUT THE 3RD OR 4TH ATTEMPT WHEN THE GUN FINALLY WAS ABLE TO GET 2 SPECIMENS. IN EACH ATTEMPT AT BIOPSY, THE TRIGGER WAS PUSHED THE ENTIRE WAY TO THE METAL END SUCH THAT IT COULD NOT HAVE BEEN DEPLOYED FURTHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858146 RBI2 SUCTION RECTAL BIOPSY SYSTEM RBI2 FCK AUS SYSTEMS PTY LTD RBI2 22409 00+B194CP12001

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male