BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSENSE CRYOABLATION SYSTEM

    MDR report key: 19114667 · Received April 16, 2024

    Report

    Report Number
    3008797959-2024-00006
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 23, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ICE BALL SIZE CONCERN WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691066 PROSENSE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH ICECURE MEDICAL LTD. FAS3100000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown