BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICURE CRYOICE CRYOSPHERE+ CRYOABLATION SYSTEM

    MDR report key: 23412815 · Received October 29, 2025

    Report

    Report Number
    23412815
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 28, 2025
    Report Date
    October 8, 2025
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    UDI-DI
    30840143911730
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE THE CRYOABLATION MACHINE WAS NOT WORKING PROPERLY AND ACCORDING TO THE REP WHO WAS HANDLING THE MACHINE, THE ISSUE WAS THAT THE BOX WOULD NOT COMPLETELY DEFROST AFTER THE FIRST USE. IT WAS REBOOTED AND FUNCTIONED PROPERLY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2741553 ATRICURE CRYOICE CRYOSPHERE+ CRYOABLATION SYSTEM DEVICE, SURGICAL, CRYOGENIC GXH ATRICURE, INC. CRYOSP-L 153896C 30840143911730

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown