BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSESNE CRYOPROBE

    MDR report key: 20128527 · Received September 3, 2024

    Report

    Report Number
    3008797959-2024-00012
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 5, 2024
    Report Date
    January 22, 2025
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    UDI-DI
    07290015487030
    PMA / PMN Number
    K183213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS DETAILED ABOVE.

    Description of Event or Problem · 0

    TIP DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277123 PROSESNE CRYOPROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ICECURE MEDICAL LTD. FAP7200000 20230817 07290015487030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other