BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RBI2 SUCTION RECTAL BIOPSY SYSTEM

    MDR report key: 13645801 · Received March 2, 2022

    Report

    Report Number
    3005921952-2022-00001
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    September 15, 2021
    Report Date
    February 17, 2022
    Manufacturer
    AUS SYSTEMS PTY LTD
    Product Code
    FCK
    UDI-DI
    00+B194CP12001
    PMA / PMN Number
    K062159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION, LOT # AND UDI NOT PROVIDED. CATALOG # INCORRECT FOR CAPSULES DEVICE. COMPLAINT RELATES TO CP1200 NOT MR100 AS REPORTED. COMPLAINT RECEIVED FROM US AGENT ON (B)(6) 2022. NO OTHER COMMUNICATION RECEIVED AND VERY LIMITED INFORMATION ON REPORT. WE HAVE REFERRED TO PRODUCT RISK ASSESSMENTS AND PRODUCT HISTORY TO ASCERTAIN LIKELY CAUSE. LIKELY CAUSE IS DUE TO USER NOT FULLY DEPRESSING TRIGGER AS PER INSTRUCTIONS SUPPLIED WITH DEVICE. ON FULL BLADE ACTIVATION THE BLADE CUTS TISSUE WITH FRONT OF CAPSULE CUTTING BOARD. IF TRIGGER IS NOT FULLY DEPRESSED TISSUE MAY BECOME HALF CUT OR SQUASHED/JAMMED AND NOT CUT. BLADE ONLY MOVES IN FORWARD DIRECTION AND NOT BACK AND FORWARD LIKE OTHER DEVICES. BASED ON THE LIMITED INFORMATION AND THE PRODUCT HISTORY WE ASSUME THAT THE USER DID NOT ACTIVATE THE TRIGGER AND BLADE CORRECTLY AS PER THE IFU. THIS ASSUMPTION HAS BEEN DERIVED FROM OTHER USERS THAT HAVE HAD THE SAME EXPERIENCED AND EACH TIME AFTER DIRECT CONTACT WITH THEM IT WAS ACCEPTED AND ACCEPTED WAS USER ERROR. MANUFACTURING STEPS ARE ALSO IN PLACE AND IT IS NOT POSSIBLE FOR AN UNSHARPENED BLADE TO BE ASSEMBLED IN THE DEVICE.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED ON (B)(6) 2022 BY PHYSICIAN TO FDA FOR AN EVENT THAT OCCURED ON (B)(6) 2021 AND BROUGHT TO OUR ATTENTION ON (B)(6) 2022 BY OUR US AGENT. NO OTHER COMMUNICATION TO THE COMPANY RECEIVED ABOUT THIS EVENT. VAGUE REPORT AND INCORRECT PART NUMBERS USED WITHIN PHYSICIAN REPORT PHYSICIAN REPORT BELOW. "THE DISPOSABLE BLADE OLD NOT CUT AND THE MUCOSA WOULD NOT RELEASE. ON REMOVAL OF THE 1ST RECTAL BIOPSY. THE BLADE DID NOT CUT THE MUCOSA. IT WAS TETHERED TO THE EQUIPMENT. REINSERTED THE EQUIPMENT ANO PUSHED THE BLADE AGAIN TO CUT. PULLED AND THE MUCOSA WAS NOT CUT. REINSERTED AND RELEASED SUCTION AND MUCOSA DID NOT DETACH. TOUCHED THE TETHERED MUCOSA AND ABLE TO RELEASE. PT DID BLEED BUT STOPPED. USED DIFFERENT RECTAL SUCTION EQUIPMENT ANO ABLE TO GET 2ND BIOPSY. PT RECOVERED ANO WHEN SHE USED THE RESTROOM. BLOOD CAME OUT AND SHE "VASOVAGATED". RAPID RESPONSE WAS CALLED AND PT WAS STABLE. PT HAD FLEX SIG DONE UNDER SEDATION FOR HEMOSTASIS WITH "CLIPS". PT ADMITTED FOR OBSERVATION. HER HEMOGLOBIN DID DROP. NO BLOOD TRANSFUSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281910 RBI2 SUCTION RECTAL BIOPSY SYSTEM RBI2 FCK AUS SYSTEMS PTY LTD RBI2 UNKNOWN 00+B194CP12001

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other