BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 19178064 · Received April 25, 2024

    Report

    Report Number
    3012018285-2024-00008
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 18, 2024
    Report Date
    October 4, 2024
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS FROM ANALYSIS OF THE DEVICE LOG AND INSPECTION OF THE RETURNED DEVICE, THE ERROR CODE 003 MALFUNCTION APPEARS TO HAVE BEEN DUE TO FLUID CONTAMINATION SHORTING THE PROGRAMMING CONNECTOR OF ONE OF THE FLEXIBLE CIRCUIT BOARDS.

    Additional Manufacturer Narrative · 0

    ANY DEVICE MALFUNCTION DURING TREATMENT CAN POTENTIALLY LEAD TO A USER ELECTING TO PERFORM A REPEAT ENDOMETRIAL ABLATION, WHICH CAN POSE A SERIOUS RISK TO HEALTH.

    Description of Event or Problem · 0

    DEVICE FUNCTIONED NORMALLY AS THE PHYSICIAN FOLLOWED THE PROMPTS ON THE SCREEN AND THE DEVICE PASSED SAFETY CHECKS. AT 120 SECONDS INTO TREATMENT, THE DEVICE LCD SCREEN SHOWED ERROR CODE 003. THE DEVICE WAS REMOVED FROM THE PATIENT AND VENTED, THE PROCEDURE WAS TERMINATED, AND THE PATIENT WAS DISCHARGED. IT WAS NOTED THAT THE PATIENT WAS TREATED IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA AND THAT THE PHYSICIAN HAD PERFORMED HYSTEROSCOPY AND D&C PRIOR TO THE PROCEDURE. AS THE DEVICE HAS NOT YET BEEN RETURNED, INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659224 CERENE CRYOTHERAPY DEVICE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 104808352 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female