BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL ICE CRYOABLATION SYSTEM

    MDR report key: 5913700 · Received August 30, 2016

    Report

    Report Number
    3004462490-2016-00003
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Date of Event
    July 21, 2016
    Report Date
    October 18, 2016
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A GALIL MEDICAL FIELD SERVICE ENGINEER VISITED THE SYSTEM AND CONFIRMED THE COMPLAINT. THE LEAK WAS DETERMINED TO BE DUE TO A RUPTURED BURST DISK. THE ARGON REGULATOR AND THE BURST DISK WERE REPLACED AND THE SYSTEM WAS TESTED TO ENSURE IT WAS LEFT IN PROPER WORKING ORDER. THE REPLACED PARTS WERE RETURNED TO GALIL MEDICAL FOR INVESTIGATION. THE PARTS WERE INSPECTED AND THE REGULATOR WAS TESTED BUT OPERATED WITHIN SPECIFICATIONS. THE CAUSE OF THE RUPTURED BURST DISK COULD NOT BE DETERMINED. ALTHOUGH IT IS UNCLEAR WHAT CAUSED THE BURST DISK TO RUPTURE, THE BURST DISK IS A SAFETY MECHANISM WITHIN THE SYSTEM DESIGNED TO BURST AND RENDER THE SYSTEM INOPERABLE IF THE GAS PRESSURE REACHES A CERTAIN THRESHOLD. IN THIS REGARD, THE BURST DISK OPERATED AS DESIGNED. GALIL MEDICAL MONITORS ALL COMPLAINTS FOR ANY POTENTIAL FAILURE TRENDS; NO TRENDS RELATED TO THIS TYPE OF FAILURE HAVE BEEN NOTED TO DATE.

    Description of Event or Problem · 1

    DURING A RENAL CRYOABLATION PROCEDURE IT WAS NOT POSSIBLE TO SET-UP THE SYSTEM PROPERLY. WHEN THE APPLICATION SPECIALIST STARTED UP THE SYSTEM THERE WAS A GAS LEAKAGE. THE SYSTEM WAS STARED UP PROPERLY AND THE HOSES WERE CONNECTED CORRECTLY. AFTER THE SPECIALIST OPENED UP THE GAS SUPPLY THERE WAS A LOUD NOISE OF GAS ESCAPING OUT OF THE SYSTEM. WHEN THE HELIUM WAS OPENED UP, EVERYTHING LOOKED OK, BUT THE NOISE APPEARED WHEN THE ARGON WAS OPENED UP. THE SPECIALIST CLOSED DOWN THE GAS AND RE-BOOTED THE SYSTEM. AGAIN WHEN HE OPENED UP THE ARGON GAS THE SYSTEM MADE A LOUD NOISE AND THE GAS LEAKED OUT OF THE SYSTEM. UNFORTUNATELY THEY NEEDED TO CANCEL THE PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME OF THIS EVENT.

    Description of Event or Problem · 1

    DURING A RENAL CRYOABLATION PROCEDURE IT WAS NOT POSSIBLE TO SET-UP THE SYSTEM PROPERLY. WHEN THE APPLICATION SPECIALIST STARTED UP THE SYSTEM THERE WAS A GAS LEAKAGE. THE SYSTEM WAS STARED UP PROPERLY AND THE HOSES WERE CONNECTED CORRECTLY. AFTER THE SPECIALIST OPENED UP THE GAS SUPPLY THERE WAS A LOUD NOISE OF GAS ESCAPING OUT OF THE SYSTEM. WHEN THE HELIUM WAS OPENED UP, EVERYTHING LOOKED OK, BUT THE NOISE APPEARED WHEN THE ARGON WAS OPENED UP. THE SPECIALIST CLOSED DOWN THE GAS AND RE-BOOTED THE SYSTEM. AGAIN WHEN HE OPENED UP THE ARGON GAS THE SYSTEM MADE A LOUD NOISE AND THE GAS LEAKED OUT OF THE SYSTEM. UNFORTUNATELY THEY NEEDED TO CANCEL THE PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566820 VISUAL ICE CRYOABLATION SYSTEM CRYOSURGICAL DEVICES AND ACCESSORIES GEH GALIL MEDICAL INC. FPRPR6000

    Patients

    Seq Age Sex Outcome Treatment
    1