BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSESNE CRYOABLATION SYSTEM

    MDR report key: 19623732 · Received June 27, 2024

    Report

    Report Number
    3008797959-2024-00011
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    May 18, 2023
    Report Date
    June 27, 2024
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ICE BALL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448764 PROSESNE CRYOABLATION SYSTEM PROSESNE CRYOABLATION SYSTEM GEH ICECURE MEDICAL LTD. FAS3000000-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other