BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSESNE CRYOABLATION SYSTEM

    MDR report key: 17832573 · Received September 28, 2023

    Report

    Report Number
    3008797959-2023-00002
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 31, 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

    FROST ON HANDLE; IT WAS REPORTED THAT NO HARM OCCURRED.

    Description of Event or Problem · 0

    FROST ON HANDLE. IT WAS REPORTED THAT NO HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100298 PROSESNE CRYOABLATION SYSTEM PROSESNE CRYOABLATION SYSTEM GEH ICECURE MEDICAL LTD. FAS3000000-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other