BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSENSE CRYOABLATION SYSTEM

    MDR report key: 23298347 · Received October 15, 2025

    Report

    Report Number
    3008797959-2025-00009
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    February 18, 2026
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ERROR MESSAGE "LOW ELEVATOR PRESSURE" (ERROR#2203)

    Description of Event or Problem · 0

    ERROR MESSAGE "LOW ELEVATOR PRESSURE" (ERROR#2203).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005285 PROSENSE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH ICECURE MEDICAL LTD. FAS3100000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other