BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSENSE CRYOABLATION SYSTEM

    MDR report key: 21999793 · Received May 11, 2025

    Report

    Report Number
    3008797959-2025-00003
    Event Type
    Malfunction
    Date Received
    May 11, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 11, 2025
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    UDI-DI
    07290015487160
    PMA / PMN Number
    K183213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    LOOSENED PIPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089500 PROSENSE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH ICECURE MEDICAL LTD. FAS3100000 07290015487160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other