BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSESNE CRYOABLATION SYSTEM

    MDR report key: 22725228 · Received August 6, 2025

    Report

    Report Number
    3008797959-2025-00006
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 7, 2025
    Report Date
    August 6, 2025
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ICE BALL SIZE CONCERN WITH PROCEDURE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225053 PROSESNE CRYOABLATION SYSTEM PROSESNE CRYOABLATION SYSTEM GEH ICECURE MEDICAL LTD. FAS3000000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other