BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSENSE CRYOABLATION SYSTEM

    MDR report key: 22327617 · Received June 25, 2025

    Report

    Report Number
    3008797959-2025-00005
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 26, 2025
    Report Date
    June 25, 2025
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ICE BALL SIZE CONCERN WITH NO REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360924 PROSENSE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH ICECURE MEDICAL LTD. FAS3100000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other