BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 2695213 · Received August 10, 2012

    Report

    Report Number
    3004462490-2012-00001
    Event Type
    Malfunction
    Date Received
    August 10, 2012
    Date of Event
    July 4, 2012
    Report Date
    July 10, 2012
    Manufacturer
    GALIL MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K113860
    Removal / Correction Number
    3004462490-08/10/12-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM SOFTWARE LOG FILES WERE REVIEWED AND THE ROOT CAUSE OF THE REPORTED ISSUE APPEARS TO BE RELATED TO A REGULATOR THAT WAS NOT OPERATING PROPERLY. A FAILURE OF THE REGULATOR RENDERS THE SYSTEM INOPERABLE BUT WILL NOT CAUSE DIRECT PT INJURY. ALTHOUGH IN THIS EVENT THE TREATMENT WAS COMPLETED SUCCESSFULLY WITH ANOTHER SYSTEM, IF THIS TYPE OF EVENT WERE TO RECUR, THE PT COULD EXPERIENCE AN UNDER TREATMENT AND WOULD REQUIRE A SECOND TREATMENT TO ENSURE ADEQUATE TUMOR COVERAGE. A FIELD CORRECTIVE ACTION (3004462490-08/10/12-001-C) FOR THIS ISSUE HAS BEEN IMPLEMENTED TO REPLACE THE REGULATORS FOR THE SYSTEMS.

    Description of Event or Problem · 1

    DURING THE TREATMENT OF A LARGE (+4 CM) RENAL MASS, IT WAS NOTED THAT THE GAS LEFT IN THE CYLINDER WAS NOT SUFFICIENT TO COMPLETE THE SECOND FREEZE. THE GAS BOTTLE WAS CLOSED OFF, THE GAS DISCHARGED AND THE NEW BOTTLE CONNECTED. THE NEW GAS BOTTLE WAS CONNECTED AND THE TREATMENT RESUMED. DR (B)(6) INDICATED THAT THERE SEEMED TO BE GAS ESCAPING FROM THE FRONT (MANIFOLD) OF THE SYSTEM AND THAT NOT ALL NEEDLES SEEMED TO BE ICING CORRECTLY. IT WAS DECIDED BY DR BREEN TO SWITCH TO THE SEEDNET SYSTEM AND THE TREATMENT WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK