BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BTG CRYOABLATION ICEFORCE 2.1CX90 CRYOABLATION NEEDLE

    MDR report key: 16312223 · Received February 6, 2023

    Report

    Report Number
    MW5114736
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 2, 2023
    Manufacturer
    GALIL MEDICAL LTD
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A CT GUIDED CYROABLATION PROCEDURE, SEVERAL CRYO PROBES FAILED, RESULTING IN AN INCOMPLETE ABLATION OF THE MASS, ALSO RESULTED IN FROST BITE TO THE PATIENT'S SKIN AT THE PROBE INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115959 BTG CRYOABLATION ICEFORCE 2.1CX90 CRYOABLATION NEEDLE UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD FPRPR3602 30125796

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female