BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 21554202 · Received March 7, 2025

    Report

    Report Number
    3012018285-2025-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 8, 2025
    Report Date
    March 7, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Removal / Correction Number
    3012018285/03102025/C/00
    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." THIS EVENT IS BEING REPORTED DUE TO THE PATIENT NOT RECEIVING A FULL TREATMENT, AS THE PHYSICIAN STOPPED THE DEVICE BEFORE TREATMENT WAS COMPLETED DUE TO A MALFUNCTION OF THE DEVICE (THE MALFUNCTION WAS NOT AFFECTING THE PATIENT'S TREATMENT). THE PHYSICIAN RECEIVED A MINOR THERMAL INJURY (I.E. BURN) THAT DID NOT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AND IS EXPECTED TO RESOLVE, THEREFORE THIS DID NOT CONSTITUTE A SERIOUS INJURY. HEALTH EFFECT CLINICAL CODE 4539 AND HEALTH EFFECT IMPACT CODE 4613 WERE ADDED TO REFLECT THAT THE PHYSICIAN RECEIVED A MINOR THERMAL INJURY. HEALTH EFFECT CLINICAL CODE 4582 AND HEALTH EFFECT IMPACT CODE 4610 REFLECT THE PATIENT NOT RECEIVING A FULL TREATMENT (THE PATIENT DID NOT EXPERIENCE ANY INJURY). THE DEVICE WAS DISCARDED BY THE PHYSICIAN'S OFFICE STAFF AND IS NOT AVAILABLE FOR EVALUATION. DEVICES FROM THE SAME LOT RETAINED BY THE MANUFACTURER WERE EVALUATED.

    Description of Event or Problem · 0

    DURING A PROCEDURE WITH THE CERENE CRYOTHERAPY DEVICE, THE PHYSICIAN NOTICED LIQUID NITROUS OXIDE LEAKING FROM THE BOTTOM OF THE DEVICE HANDLE DURING THE ACTIVE TREATMENT PORTION OF THE PROCEDURE. HE PAUSED THE DEVICE, BUT THE DRIPPING CONTINUED. THE PHYSICIAN NOTED THAT THE LIQUID NITROUS OXIDE DID DRIP ONTO HIS LEG, LEAVING A BURN. HE STATED THAT HE DID NOT REQUIRE TREATMENT FOR THIS THERMAL INJURY AND EXPECTED IT TO RESOLVE. THE PHYSICIAN STATED THAT HE STOPPED THE DEVICE NEAR THE END OF THE TREATMENT AS IT CONTINUED TO LEAK AND DID NOT NOTE ANY ERROR CODES. HIS ASSISTANT NOTED THAT THE EXHAUST COLLECTION BAG WAS NOT AS FULL AS THEY SEE WITH A TYPICAL PROCEDURE. THE PATIENT WAS DISCHARGED WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139068 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 108638953 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female