BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RB12 SUCTION RECTAL BIOPSY MANOMETER

    MDR report key: 13592122 · Received February 23, 2022

    Report

    Report Number
    MW5107662
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    September 15, 2021
    Report Date
    January 3, 2022
    Manufacturer
    AUS SYSTEMS PTY LTD.
    Product Code
    FCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DISPOSABLE BLADE DID 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 AND 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 AND ABLE TO GET 2ND BIOPSY. PT RECOVERED AND WHEN SHE USED THE RESTROOM, BLOOD CAME OUT AND SHE "HASOVAGATED". RAPID RESPONSE WAS CALLED AND PT WAS STABLE. PT HAD FLEX SIG DONE UNDER SEDATION FOR HEMOSTASIS WITH DIPS. PT ADMITTED FOR OBSERVATION. HER HEMOGLOBIN DID DROP. NO BLOOD TRANSFUSION.

    Description of Event or Problem · 0

    THE DISPOSABLE BLADE DID 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 AND 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 AND ABLE TO GET 2ND BIOPSY. PT RECOVERED AND WHEN SHE USED THE RESTROOM, BLOOD CAME OUT AND SHE "HASOVAGATED". RAPID RESPONSE WAS CALLED AND PT WAS STABLE. PT HAD FLEX SIG DONE UNDER SEDATION FOR HEMOSTASIS WITH DIPS. PT ADMITTED FOR OBSERVATION. HER HEMOGLOBIN DID DROP. NO BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863090 RB12 SUCTION RECTAL BIOPSY MANOMETER INSTRUMENT, BIOPSY, SUCTION FCK AUS SYSTEMS PTY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Hospitalization