BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE® CRYOABLATION SYSTEM

    MDR report key: 6822701 · Received August 25, 2017

    Report

    Report Number
    3004462490-2017-00006
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 31, 2017
    Report Date
    August 25, 2017
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS NOT RETURNED TO GALIL FOR PHYSICAL INVESTIGATION. INSTEAD, THE GALIL MEDICAL DISTRIBUTOR SENT PICTURES OF THE SYSTEM TO GALIL MEDICAL TECHNICAL SUPPORT IN (B)(4). THE PICTURE SHOWED A DUAL IMAGE ON THE SCREEN, AND THE COLORING WAS INCORRECT. IT WAS DETERMINED TO SEND A MONITOR ASSEMBLY AND AN ELECTRICAL TRAY TO THE DISTRIBUTOR. THE DISTRIBUTOR FIELD SAFETY ENGINEER REPLACED BOTH THE MONITOR AND ELECTRICAL TRAY. AFTER REPLACING THE PARTS, THE SYSTEM BOOTED UP NORMALLY AND THE SYSTEM PASSED ALL TESTING PER THE SERVICE REQUIREMENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 2 MINUTES INTO CRYOABLATION PROCEDURE, THE OPERATOR STOPPED THE FREEZE CYCLE AS THE PATIENT FELT A PAIN. THE PATIENT WAS UNDER LOCAL ANESTHESIA AT THE TIME. THE PHYSICIAN STOPPED THE PROCEDURE AS THE OPERATOR WAS UNABLE TO REBOOT THE SYSTEM AFTER MANY RESTARTS. THE OPERATOR TRIED TO RESTART THE SYSTEM AFTER A LONG WAIT. THE SYSTEM REBOOTED SUCCESSFULLY AND OPERATED NORMALLY. THE PHYSICIAN DID NOT CONSIDER THE PROCEDURE SUCCESSFUL THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602512 VISUAL-ICE® CRYOABLATION SYSTEM CRYOSURGICAL DEVICES AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1