BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSENSE CRYOABLATION SYSTEM

    MDR report key: 17909447 · Received October 10, 2023

    Report

    Report Number
    3008797959-2023-00006
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    July 19, 2023
    Report Date
    October 11, 2023
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    AS DETAILED ABOVE. THE DEVICE WAS SERVICED BY THE DISTRIBUTOR'S TRAINED SERVICE TECHINICAN.

    Description of Event or Problem · 0

    LN2 EXCESSIVE VAPOR THAT RESULTED IN PROCEDURE CANCELLATION WAS REPORTED, WITH NO REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180678 PROSENSE CRYOABLATION SYSTEM PROSENSE CRYOABLATION SYSTEM GEH ICECURE MEDICAL LTD. FAS3100000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other