BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 21876446 · Received April 21, 2025

    Report

    Report Number
    3012018285-2025-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 18, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 378 IS "UTERUS PARTIALLY TREATED, END PROCEDURE, DO NOT RE-TREAT." NO INJURY OR ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 0

    THE PHYSICIAN ENCOUNTERED A DEVICE MALFUNCTION WHILE USING THE CERENE CRYOTHERAPY DEVICE. THE DEVICE OPERATED NORMALLY UNTIL 23 SECONDS AFTER ACTIVE ABLATIVE TREATMENT HAD STARTED, AT WHICH TIME THE LCD SCREEN DISPLAYED ERROR CODE 378. THE DEVICE WAS REMOVED FROM THE PATIENT AND VENTED. THE PROCEDURE WAS TERMINATED AND THE PATIENT WAS DISCHARGED WITH NO ADVERSE EVENTS REPORTED. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT A LARGE SPIKE IN PRESSURE TRIGGERED THE EC378 FAULT. VISUAL INSPECTION RESULTED IN NO OBSERVATIONS OF NOTE. RE-TESTING OF THE DEVICE RESULTED IN COMPLETION OF THE TREATMENT SEQUENCE WITHOUT ISSUE. BASED ON THIS DATA AND A PREVIOUS COMPLAINT RECORD, THE LIKELIEST ROOT CAUSE FOR THIS FAULT IS OCCLUSION OF THE COLLECTION TUBING AT THE INTERFACE WITH THE EXHAUST COLLECTION BAG DUE TO UNINTENTIONAL TWISTING OF THE EXHAUST COLLECTION BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911199 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 110163477 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female