BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 20453432 · Received October 15, 2024

    Report

    Report Number
    3012018285-2024-00023
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 16, 2024
    Report Date
    November 21, 2024
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 390 IS "UTERUS PARTIALLY TREATED, END PROCEDURE, DO NOT RE-TREAT." NO INJURY OR ADVERSE EVENTS WERE REPORTED. DEVICE WAS DISCARDED AND NOT AVAILABLE FOR TESTING.

    Additional Manufacturer Narrative · 0

    AS THE DEVICE WAS NOT RETURNED, THE INVESTIGATION CONCLUSION OF USER ERROR WAS BASED ON THE COMPLAINT REPORT, WHICH STATED THAT THE USER PAUSED AND STOPPED THE DEVICE AS THEY WERE UNSURE IF THE CAVITY RETRACTION STEP HAD BEEN PERFORMED CORRECTLY. 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 390 IS "UTERUS PARTIALLY TREATED, END PROCEDURE, DO NOT RE-TREAT." NO INJURY OR ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 0

    THE CERENE CRYOTHERAPY DEVICE REPORTED ERROR CODE 390 DURING THE DELIVERY OF CRYOABLATION. THE PHYSICAN WAS UNCERTAIN WHETHER SHE HAD RETRACTED THE DEVICE TO THE UTERINE CAVITY LENGTH AND MAY HAVE INADVERTENTLY PRESSED THE BUTTON TOO MANY TIMES, PAUSING THE DEVICE (WHICH ULTIMATELY TIMED OUT). THE PHYSICIAN ELECTED TO OPEN A SECOND DEVICE, THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS SUCCESSFULLY TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36145 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 104521904 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female