BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSENSE CRYOABLATION SYSTEM

    MDR report key: 17909454 · Received October 10, 2023

    Report

    Report Number
    3008797959-2023-00009
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    May 19, 2022
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS DETAILED ABOVE.

    Description of Event or Problem · 0

    ICE ON THE HANDLE WAS REPORTED, WITH NO REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180685 PROSENSE CRYOABLATION SYSTEM PROSENSE CRYOABLATION SYSTEM GEH ICECURE MEDICAL LTD. FAS3000000-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other