BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RBI2 SUCTION RECTAL BIOPSY SYSTEM

    MDR report key: 22041055 · Received May 17, 2025

    Report

    Report Number
    3005921952-2025-00001
    Event Type
    Malfunction
    Date Received
    May 17, 2025
    Report Date
    May 17, 2025
    Manufacturer
    AUS SYSTEMS PTY LTD
    Product Code
    FCK
    UDI-DI
    B194CP12001
    PMA / PMN Number
    K062159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HANDPIECE WAS SENT BACK FOR EVALUATION. UPON RECEIPT, IT WAS FOUND TO BE IMPROPERLY ASSEMBLED- SPECIFICALLY, THE SPRING AND LOCKNUT WERE INSERTED BEFORE THE SHAFT, CONTRARY TO MANUFACTURER SPECIFICATIONS. THIS REASSEMBLY APPEARS TO HAVE BEEN DONE POST-PROCEDURE BY STERILIZATION STAFF. THE DEVICE WAS CORRECTLY REASSEMBLED BY THE MANUFACTURER AND TESTED WITH A CAPSULE. THE BLADE SUCCESSFULLY ACTUATED FULLY, INDICATING NO FUNCTIONAL DEFECT WITH THE DEVICE. USER DISCUSSIONS REVEALED THAT CLINICAL PERSONNEL MAY NOT HAVE FULLY ACTUATED THE BLADE DURING THE PROCEDURE, POSSIBLY CONTRIBUTING TO THE INCIDENT. THE MANUFACTURER IS INITIATING RETRAINING EFFORTS TO REINFORCE CORRECT ASSEMBLY AND ACTUATION TECHNIQUES. THE DEVICE OPERATED AS INTENDED WHEN CORRECTLY ASSEMBLED. THE PROBABLE ROOT CAUSE IS USER ERROR DUE TO INCOMPLETE BLADE ACTUATION OR IMPROPER HANDLING.

    Description of Event or Problem · 0

    BLADE STOPPED HALFWAY THROUGH, GOT STUCK AND THE GENERAL SURGERY TEAM WAS CALLED IN TO REMOVE THE BLADE AND SUTURE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167077 RBI2 SUCTION RECTAL BIOPSY SYSTEM RBI2 FCK AUS SYSTEMS PTY LTD RBI2 B194CP12001

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown