BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 11258528 · Received February 1, 2021

    Report

    Report Number
    2134265-2021-00982
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 11, 2021
    Report Date
    April 1, 2021
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A FIELD SERVICE ENGINEER WENT TO THE HEALTH CARE FACILITY TO PERFORM PREVENTIVE MAINTENANCE, AHEAD OF THE SCHEDULE, IN RESPONSE TO THIS EVENT. PRODUCT MAINTENANCE TESTING FOUND LOW GAS PRESSURE WITHIN ONE OF THE CHANNELS INDICATING SATURATION OF THE DESICCANT TUBE. THEREFORE, ALL OF THE DESICCANT TUBES WERE REPLACED AND THE SYSTEM WAS THEN IN PROPER WORKING ORDER. SATURATION CAN OCCUR OVER TIME AS THE RESULT OF MOISTURE WITHIN THE GAS SYSTEM DUE TO THE FOLLOWING: WATER VAPOR WITHIN THE GAS CYLINDER, MOISTURE WITHIN THE SUPPLY LINES OR TUBING ON THE CONSOLE, OR MOISTURE WITHIN TUBING AT THE CUSTOMER SITE (SHOULD THEY HAVE INFRASTRUCTURE TO CONNECT THE GAS CYLINDERS TO THE CONSOLE FROM A REMOTE LOCATION). LOCAL HUMIDITY, STORAGE CONDITIONS, AND FREQUENCY OF DEVICE USE CAN ALSO BE A FACTOR IN THE LIFE CYCLE OF THE DESICCANT. H3 OTHER TEXT : DEVICE EVALUATED BY THIRD PARTY DISTRIBUTOR

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VISUAL-ICE SYSTEM FAILED TO REACH AND MAINTAIN THE DESIRED FREEZING TEMPERATURE FOR ALL THREE NEEDLES USED DURING A SOFT TISSUE CRYOABLATION PROCEDURE. THE ISSUE COULD NOT BE RESOLVED; HOWEVER, THE ICE CREATED WAS SUFFICIENT IN COVERING THE ENTIRE ABLATION ZONE. THE PHYSICIAN WAS SATISFIED WITH THE OUTCOME AND THE TREATMENT WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VISUAL-ICE SYSTEM FAILED TO REACH AND MAINTAIN THE DESIRED FREEZING TEMPERATURE FOR ALL THREE NEEDLES USED DURING A SOFT TISSUE CRYOABLATION PROCEDURE. THE ISSUE COULD NOT BE RESOLVED; HOWEVER, THE ICE CREATED WAS SUFFICIENT IN COVERING THE ENTIRE ABLATION ZONE. THE PHYSICIAN WAS SATISFIED WITH THE OUTCOME AND THE TREATMENT WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156879 VISUAL-ICE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 VL0298 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1