BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 4820166 · Received June 4, 2015

    Report

    Report Number
    3004462490-2015-00012
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 21, 2015
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLES WERE NOT RETURNED SO AN INVESTIGATION COULD NOT BE CONDUCTED. HOWEVER, IT IS LIKELY THE GAS FLOW ISSUE WAS DUE TO MOISTURE CONTAMINATION IN THE GAS SUPPLY LINES USED WITH THE VISUAL ICE SYSTEM. GALIL MEDICAL HAS IMPLEMENTED AN AUTOMATIC FLUSH SEQUENCE IN SOFTWARE VERSION 1.2.9 AND HAS MADE SHORTER GAS LINES AVAILABLE TO CUSTOMERS. MOISTURE CAUSING A GAS CLOG IN A NEEDLE IS A KNOWN INHERENT RISK IN ANY CRYOABLATION PROCEDURE. THE VISUAL ICE USER MANUAL PROVIDES TROUBLESHOOTING INSTRUCTIONS ON FLUSHING A NEEDLE IF A CUSTOMER SUSPECTS A GAS CLOG.

    Description of Event or Problem · 1

    DURING THE 3RD FREEZE CYCLE OF A CRYOABLATION PROCEDURE, THE NEEDLE CLOGGED AND WOULD NOT FORM ICE. THE 1ST AND 2ND FREEZE/THAW CYCLES WERE FINE. THE SYSTEM AND NEEDLES WERE TESTED BEFORE THE CASE AND GAS LINES WERE PURGED AS RECOMMENDED. THE DOCTOR THINKS HE GOT THE TUMOR ON THE 1ST FREEZE BUT WILL WAIT FOR THE FOLLOW UP EXAM IN 3 MONTHS TO RUN TESTS. THE TECH CALLED THE GALIL MEDICAL REPRESENTATIVE AND SHE THOUGHT IT MIGHT BE A MOISTURE PROBLEM. MACHINE HAS THE 8 METER LINES. CASE COMPLETED WITH NO INJURY TO THE PATIENT. NEEDLE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362292 VISUAL ICE CRYOABLATION SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S