BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 6265435 · Received January 19, 2017

    Report

    Report Number
    3004462490-2017-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    December 22, 2016
    Report Date
    February 6, 2017
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A GALIL MEDICAL TRAINED FSE VISITED AND SERVICED THE SYSTEM. THE FSE FOUND THE ARGON LEAK COMING FROM THE ARGON BURST DISK. THE FSE REPLACED THE BURST DISK, TWO DRYER MANIFOLD CHECK VALVES, AND THE ARGON REGULATOR. FUNCTIONAL TESTING WAS CONDUCTED ON THE SYSTEM AND THE SYSTEM MET ALL SPECIFICATIONS. THE COMPONENTS WERE SENT TO GALIL FOR INVESTIGATION. UPON VISUAL INSPECTION, NO EXTERNAL DAMAGE NOTED. THE BURST DISK ASSEMBLY WAS INSPECTED WITHOUT DISASSEMBLY AND NO BREAKS WERE OBSERVED. THE ASSEMBLY WAS PRESSURIZED AND AT 1800 PSI IT STARTED TO LEAK. THE LEAK WAS OBSERVED TO BE COMING FROM THE THREADED AREA OF THE BURST DISK ASSEMBLY. THE WAS OBSERVED TO HAVE BECOME LOOSENED AS, WHEN TORQUED BELOW THE SPECIFICATION, THE CAP DISPLAYED MOTION. THE ARGON REGULATOR THAT WAS RETURNED WAS ALSO INSPECTED AND TESTED TO FOR OUTPUT PRESSURE. THE INPUT PRESSURE WAS SET TO APPROXIMATELY 4000 PSI, THE OUTPUT WAS AT 3520 PSI, A NORMAL AND EXPECTED READING. THE REGULATOR WAS MONITORED FOR 10 MINUTES AND NO REGULATOR CREEP NOTED. LEAK WAS DETERMINED TO BE DUE TO THE BURST DISK ASSEMBLY NOT BEING AT THE PROPER TORQUE VALUE. THE CUSTOMER COMPLAINT OF AN ARGON LEAK CONFIRMED.

    Description of Event or Problem · 1

    DURING A RENAL PROCEDURE, THE PHYSICIAN OBSERVED A STRONG ARGON LEAKAGE COMING FOR INSIDE THE SYSTEM AND THE PRESSURE AT THE CYLINDER DROPPED AT A RATE OF 3BARS/SECOND. THE PROCEDURE WAS ABORTED UPON OPENING THE SYSTEM, THE LOCAL FSE OBSERVED THAT THE LEAKAGE WAS COMING FORM THE DISK BURST.

    Description of Event or Problem · 1

    DURING A RENAL PROCEDURE, THE PHYSICIAN OBSERVED A STRONG ARGON LEAKAGE COMING FOR INSIDE THE SYSTEM AND THE PRESSURE AT THE CYLINDER DROPPED AT A RATE OF 3BARS/SECOND. THE PROCEDURE WAS ABORTED UPON OPENING THE SYSTEM, THE LOCAL FSE OBSERVED THAT THE LEAKAGE WAS COMING FORM THE DISK BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46148 VISUAL ICE CRYOABLATION SYSTEM CRYOSURGICAL DEVICES AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000

    Patients

    Seq Age Sex Outcome Treatment
    1