BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 10540729 · Received September 16, 2020

    Report

    Report Number
    2134265-2020-12612
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 18, 2020
    Report Date
    November 18, 2020
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AGE AT TIME OF EVENT A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. PER THE MANUFACTURER'S TECHNICAL SERVICES MANAGER, THE NEEDLE CLOG WAS LIKELY DUE TO SATURATED DESICCANT TUBES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. A NEW PREVENTATIVE MAINTENANCE (PM) KIT CONTAINING NEW LARGER DIAMETER DESICCANT TUBES AND 6G OF DESICCANT PER TUBE WAS ISSUED TO THE DISTRIBUTOR, CHINDEX MEDICAL LTD., AND SERVICE WAS PERFORMED. A FUNCTIONAL TEST WAS COMPLETED AND THE DEVICE OPERATED AS EXPECTED. THE SYSTEM WAS SENT BACK TO THE HOSPITAL FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VISUAL-ICE SYSTEM FAILED TO GENERATE ADEQUATE ICE. A PATIENT UNDERWENT RENAL CRYOABLATION WITH A VISUAL-ICE SYSTEM AND FOUR ICEROD CX NEEDLES. THE NEEDLES WERE TESTED AND CONFIRMED TO HAVE NO ISSUES PRIOR TO USE. THE PATIENT RECEIVED LOCAL ANESTHESIA AROUND THE NEEDLE INSERTION SITE. AFTER POSITIONING THE NEEDLES AT THE TUMOR, THE CRYOABLATION SYSTEM FAILED TO GENERATE ADEQUATE ICE. TROUBLESHOOTING WAS PERFORMED BY AN ON-SITE SERVICE ENGINEER AND THE SYSTEM FUNCTIONED AGAIN ABOUT ONE HOUR LATER AND THE PROCEDURE WAS CONTINUED AS PLANNED. THE TUMOR ABLATION ZONE WAS MONITORED WITH CT IMAGING AND APPEARED TO BE ADEQUATE. NO PATIENT INJURY OR HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VISUAL-ICE SYSTEM FAILED TO GENERATE ADEQUATE ICE. A PATIENT UNDERWENT RENAL CRYOABLATION WITH A VISUAL-ICE SYSTEM AND FOUR ICEROD CX NEEDLES. THE NEEDLES WERE TESTED AND CONFIRMED TO HAVE NO ISSUES PRIOR TO USE. THE PATIENT RECEIVED LOCAL ANESTHESIA AROUND THE NEEDLE INSERTION SITE. AFTER POSITIONING THE NEEDLES AT THE TUMOR, THE CRYOABLATION SYSTEM FAILED TO GENERATE ADEQUATE ICE. TROUBLESHOOTING WAS PERFORMED BY AN ON-SITE SERVICE ENGINEER AND THE SYSTEM FUNCTIONED AGAIN ABOUT ONE HOUR LATER AND THE PROCEDURE WAS CONTINUED AS PLANNED. THE TUMOR ABLATION ZONE WAS MONITORED WITH CT IMAGING AND APPEARED TO BE ADEQUATE. NO PATIENT INJURY OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005562 VISUAL-ICE CRYOABLATION SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 VL0289 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1