BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BTG ICEFORCE

    MDR report key: 9915564 · Received April 2, 2020

    Report

    Report Number
    9915564
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 16, 2020
    Manufacturer
    GALIL MEDICAL LTD
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ICEFORCE CX PROBE FAILED TO THAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379521 BTG ICEFORCE UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD CX 2.1

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA