BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 2713321 · Received August 22, 2012

    Report

    Report Number
    3004462490-2012-00002
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 6, 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 WAS DETERMINED 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. IN THIS EVENT, THE TREATMENT WAS EXTENDED TO ENSURE ADEQUATE CRYOTHERAPY WAS DELIVERED. EVEN WITH THE EXTENDED TREATMENT THE PT COULD HAVE EXPERIENCED AN UNDER TREATMENT AND MAY REQUIRE A SECOND TREATMENT TO ENSURE ADEQUATE TUMOR COVERAGE. THE PHYSICIAN WILL RE-EVALUATE THE PT AT A LATER DATE. A FIELD CORRECTIVE ACTION (3004462490-08/10/12-001-C) FOR THIS ISSUE HAS BEEN IMPLEMENTED TO REPLACE THE REGULATORS FOR THE SYSTEM.

    Description of Event or Problem · 1

    DURING A RENAL TREATMENT, IT WAS FELT THAT THEY HAD NOT HAD "GOOD" ICE ON THE SECOND FREEZE. THE FREEZE WAS EXTENDED TO TRY TO COMPENSATE FOR THE LACK OF ICE VOLUME. THE PHYSICIAN FELT THAT THE TREATMENT WAS SUB-OPTIMAL. IT IS POSSIBLE THAT THEY MAY NEED TREATMENT, HOWEVER, THIS WILL NOT BE DETERMINED FOR AT LEAST 3 MONTHS.

    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