BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUAL-ICE CRYOABLATION SYSTEM

    MDR report key: 2713341 · Received August 22, 2012

    Report

    Report Number
    3004462490-2012-00003
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    August 6, 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 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. IN THIS EVENT, THE TREATMENT WAS EXTENDED TO ENSURE ADEQUATE CRYOTHERAPY WAS DELIVERED. EVENT 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-EVALUATED 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 TUMOR CASE, THE PHYSICIAN INDICATED THAT THE NEEDLES DID NOT SEEM TO FREEZE WELL DURING THE SECOND FREEZE. THE DOCTOR FELT THAT THE ICEBALL DID NOT GROW AS ANTICIPATED, AND IT SEEMED TO HAPPEN AS THE GAS LEFT IN THE BOTTLE DROPPED. THEY DID NOT CHANGE THE GAS BOTTLE AT THIS TIME, AS THEY FELT THAT THE AMOUNT OF GAS LEFT WAS STILL, OR SHOULD HAVE BEEN SUFFICIENT. THE FREEZE WAS EXTENDED TO OVERCOME APPARENT SHORTFALL IN THE ICEBALL. THE DOCTOR HAS A CONCERN THAT THIS PT MAY HAVE REC'D A SUB OPTIMAL 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