BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSENSE CRYOABLATION SYSTEM

    MDR report key: 17467236 · Received August 6, 2023

    Report

    Report Number
    3008797959-2023-00001
    Event Type
    Malfunction
    Date Received
    August 6, 2023
    Date of Event
    July 12, 2023
    Report Date
    December 3, 2023
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS DETAILED ABOVE.

    Description of Event or Problem · 0

    ERROR CODE 916. IT WAS REPORTED THAT NO HARM OCCURRED.

    Description of Event or Problem · 0

    ERROR CODE: 916. IT WAS REPORTED THAT NO HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967237 PROSENSE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH ICECURE MEDICAL LTD. FAS3100000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other