BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 22122313 · Received June 2, 2025

    Report

    Report Number
    22122313
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    April 2, 2025
    Report Date
    May 23, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE CERENE PROBE WOULD NOT RESPOND WHILE BEING SET UP FOR USE, AND AN ERROR CODE WAS DISPLAYED. A NEW PROBE WAS HANDED TO THE STERILE FIELD, AND THE DEFECTIVE ONE WAS REMOVED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736182 CERENE CRYOTHERAPY DEVICE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 110163477

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female