BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE® CRYOABLATION SYSTEM

    MDR report key: 7033515 · Received November 15, 2017

    Report

    Report Number
    3004462490-2017-00009
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 17, 2017
    Report Date
    December 13, 2017
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    UDI-DI
    00867379000006
    PMA / PMN Number
    K113860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR FIELD SAFETY ENGINEER CONFIRMED CUSTOMER COMPLAINT. INVESTIGATION SHOWED THAT THE OUTLET FILTERS WERE ALL PARTIALLY CLOGGED WITH DESICCANT CAUSING LOW OUTPUT PRESSURE. REPLACEMENT OF THE DESICCANT TUBES AND SOCKETS CORRECTED THE ISSUE. THE MOST COMMON CAUSE OF INSUFFICIENT ICE RELATED TO DESICCANT TUBES IS WHEN THE OUTLET GAS FILTERS BECOME CLOGGED IMPEDING GAS FLOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ICEBALL SIZE DID NOT COVER THE ENTIRE TUMOR. THE CUSTOMER ALSO STATED THAT THE VISUAL ICE SYSTEM USED DURING THE CASE HAD PREVENTATIVE MAINTENANCE PERFORMED IN JULY AND BELIEVES THAT THE INSUFFICIENT PERFORMANCE BEGAN JUST AFTER THIS SERVICE. THE DOCTOR REPORTED THAT THE PATIENT WILL NEED TO BE RE-TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813914 VISUAL-ICE® CRYOABLATION SYSTEM CRYOSURGICAL DEVICES AND ACCESSORIES GEH GALIL MEDICAL INC. FPRCH6000 00867379000006

    Patients

    Seq Age Sex Outcome Treatment
    1