BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSESNE CRYOABLATION SYSTEM

    MDR report key: 25196270 · Received May 17, 2026

    Report

    Report Number
    3008797959-2026-00001
    Event Type
    Injury
    Date Received
    May 17, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 17, 2026
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    UDI-DI
    07290015487160
    PMA / PMN Number
    K183213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT LUNG CRYOABLATION PROCEDURE. DURING THE SECOND PROBE INSERTION/POSITIONING, A MILD PNEUMOTHORAX OCCURRED INTRA-PROCEDURALLY. THE PHYSICIAN ASSESSED THE EVENT AS A NON-SERIOUS, MILD ADVERSE EVENT WITH NO EVIDENCE OF DEVICE MALFUNCTION OR DEFICIENCY. THE EVENT ALIGNS WITH KNOWN RISKS OF LUNG CRYOABLATION PROCEDURES DESCRIBED IN THE DEVICE LABELING AND USER MANUAL, AND THE COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444493 PROSESNE CRYOABLATION SYSTEM GEH ICECURE MEDICAL LTD. FAS3100000 07290015487160

    Patients

    Seq Age Sex Outcome Treatment
    1