BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RBI2 SUCTION RECTAL BIOPSY SYSTEM

    MDR report key: 20934264 · Received December 14, 2024

    Report

    Report Number
    3005921952-2024-00006
    Event Type
    Malfunction
    Date Received
    December 14, 2024
    Date of Event
    October 24, 2024
    Report Date
    December 15, 2024
    Manufacturer
    AUS SYSTEMS PTY LTD
    Product Code
    FCK
    PMA / PMN Number
    K062159
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCIDENT LIKELY RESULTED FROM USER ERROR, SPECIFICALLY PRESSURE AGAINST MUCOSA WALL AND NOT IN A NEUTRAL POSITION AND INSUFFICIENT UNDERSTANDING OF OPERATIONAL PROCEDURES, INCLUDING SUCTION RELEASE TIMING.

    Description of Event or Problem · 0

    PATIENT UNDERGOING SUCTION RECTAL BIOPSY. FIRST TWO TISSUES SPECIMENS OBTAINED WITH NO ISSUES. ON THE THIRD ATTEMPT, AFTER TRIGGERING THE BIOPSY DEVICE, THE CARTRIDGE WAS UNABLE TO BE REMOVED FROM PATIENT'S ANUS. THE BIOPSY DEVICE WAS REMOVED AND CARTRIDGE WAS STILL UNABLE TO BE REMOVED FROM PATIENT'S ANUS AND APPEARED TO BE CAUGHT ON TISSUE. FELLOW WAS CALLED TO BEDSIDE. BIOPSY DEVICE WAS REINSERTED AND TRIGGER WAS PULLED AGAIN. THE BIOPSY DEVICE ALONG WITH THE CARTRIDGE WAS THEN EASILY REMOVED. SMALL AMOUNT OF BLEEDING NOTED IN DIAPER. TISSUE SAMPLE WAS REMOVED FROM CARTRIDGE AND SENT TO LAB WITH THE FIRST TWO TISSUE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366083 RBI2 SUCTION RECTAL BIOPSY SYSTEM RBI2 FCK AUS SYSTEMS PTY LTD RBI2 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male