BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 20751199 · Received November 21, 2024

    Report

    Report Number
    3012018285-2024-00024
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 26, 2024
    Report Date
    March 7, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. LABELING FOR THE CERENE CRYOTHERAPY DEVICE STATES THAT THE "TREATMENT STATUS AND NEXT STEPS" FOR ERROR CODE 305 IS "UTERUS PARTIALLY TREATED, END PROCEDURE, DO NOT RE-TREAT." NO INJURY OR ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 0

    WHILE THE INITIAL COMPLAINT REPORTED ERROR CODE 305, INVESTIGATION OF THE RETURNED DEVICE REVEALED ERROR CODE 265 (LEAK DETECTED) OCCURING PRIOR TO TREATMENT. THEREFORE, THIS EVENT DID NOT CONSTITUTE AN MDR-REPORTABLE MALFUNCTION. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE ROOT CAUSE FOR THE ERROR CODE 265 WAS DETERMINED TO BE PARTICULATE ON THE DOME VALVE SEALING SURFACE, ARISING FROM A PIECE OF POLYMER THAT IS BELIEVED TO HAVE BEEN SKIVED OFF AT THE PRESS JUNCTION FOR THE DOME VALVE BASE.

    Description of Event or Problem · 0

    THE CERENE CRYOTHERAPY DEVICE WAS USED FOR ENDOMETRIAL ABLATION. THE DEVICE WAS REMOVED FROM THE PACKAGE, PREPARED, TURNED ON, AND INSERTED INTO THE PATIENT. AT AN UNDISCLOSED TIME, THE DEVICE INDICATED ERROR CODE 305. THE PHYSICIAN ELECTED TO OPEN A SECOND DEVICE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TREATED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765390 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 106935539 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female