BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RBI2 SUCTION RECTAL BIOPSY SYSTEM

    MDR report key: 20934278 · Received December 14, 2024

    Report

    Report Number
    3005921952-2024-00005
    Event Type
    Malfunction
    Date Received
    December 14, 2024
    Date of Event
    September 27, 2024
    Report Date
    December 14, 2024
    Manufacturer
    AUS SYSTEMS PTY LTD
    Product Code
    FCK
    PMA / PMN Number
    K062159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION OF CAPSULE: BLADE, HOLE SHAPE, AND HOLDING SLOTS WERE INSPECTED. DIMENSIONS MATCHED SPECIFICATIONS PER DRAWING # 0005-AUS REV.1, WITHIN TOLERANCE LEVELS. VISUAL INSPECTION SHOWED NO SIGNS OF THE CAPSULE BEING TWISTED TO LOCK ON POSITION. FUNCTION TESTING: CAPSULE FROM LOT # 22318 WAS PLACED ONTO A HP1000 AND TWISTED AND IT SECURELY LOCKED ONTO THE LUGS. THE CAPSULE FIRED NORMALLY, ENGAGING WITH THE CUTTING BOARD, WITH CUTTING BOARD CUT RESISTANCE WITHIN NORMAL PARAMETERS. ACTIVATION ISSUE: THE CAPSULE HAD NOT BEEN ACTIVATED DURING USE, AND THE INNER PISTON WAS UNABLE TO PUSH OR FIRE THE BLADE DUE TO THE CAPSULE NOT BEING LOCKED ONTO HP1000 LOCKING LUGS. THE CLICKING NOISE MENTIONED BY THE OPERATOR SUGGESTS THE TRIGGER WAS ACTIVATED AND COMPLETELY PUSHED THE CAPSULE OFF THE HP1000. ROOT CAUSE ANALYSIS: BLADE FUNCTIONALITY: THE BLADE WAS NOT FIRED, DID NOT LEAVE ITS ASSEMBLED POSITION, AND COULD NOT PHYSICALLY ENGAGE WITH THE MUCOSA WALL. DESIGN CONSIDERATIONS: ONCE FIRED, THE BLADE DESIGN ENSURES IT CANNOT RETRACT AND REMAINS IN THE FIRED POSITION. THIS EXPLAINS WHY THE CAPSULE COULD BE REMOVED SUCCESSFULLY AFTER THE PATIENT PASSED STOOL. OPERATIONAL OVERSIGHT: THE CAPSULE WAS NOT TWISTED AND LOCKED PROPERLY ONTO THE HANDPIECE DURING INITIAL USE. INSTEAD, IT WAS LIKELY PUSHED FORWARD INTO THE PATIENT DUE TO IMPROPER MOUNTING. UPON PATIENT STOOLING, THE CAPSULE WAS PUSHED OUT BECAUSE THE BLADE REMAINED INACTIVE, RESULTING IN NO TISSUE CAPTURE OR BLEEDING. CONCLUSION: THE FAILURE WAS CAUSED BY THE CAPSULE NOT BEING TWISTED AND LOCKED ONTO THE HANDPIECE, LEADING TO IMPROPER DEPLOYMENT DURING USE. THIS MECHANICAL OVERSIGHT PREVENTED THE BLADE FROM FIRING, CONFIRMING NO FAULT IN THE CAPSULE'S DESIGN OR MANUFACTURING. PROPER LOCKING AND ACTIVATION PROCEDURES SHOULD RESOLVE SUCH ISSUES IN FUTURE USE.

    Description of Event or Problem · 0

    SUCTION RECTAL BIOPSY WAS PERFORMED SUCCESSFULLY X2. ON THE THIRD ATTEMPT AFTER TRIGGERING THE SUCTION RECTAL BIOPSY GUN THERE WAS A CLICKING NOISE. THE CAPSULE WAS UNABLE TO BE REMOVED FROM PT'S RECTUM AND FOUND TO BE STUCK ON RECTAL MUCOSA. DR, PED SURG FELLOW NOTIFIED. SHE ATTEMPTING TO FLUSH AND PROBE THE CAPSULE. AFTER ABOUT 40 MINUTES IT WAS SUCCESSFULLY REMOVED AFTER PATIENT STOOLED ON THEIR OWN. NO TISSUE NOTED IN CARTRIDGE ON REMOVAL. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2496487 RBI2 SUCTION RECTAL BIOPSY SYSTEM RBI2 FCK AUS SYSTEMS PTY LTD RBI2 U22318

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female