BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESICE

    MDR report key: 2123213 · Received August 21, 2008

    Report

    Report Number
    9616793-2008-00004
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    May 29, 2008
    Report Date
    August 14, 2008
    Manufacturer
    GALIL MEDICAL
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REPORT WAS RECEIVED, THE FIELD SERVICE STAFF WAS SENT TO THE USER LOCATION TO ASSESS THE PRODUCT. THE FIELD SERVICE STAFF DID A FULL ASSESSMENT AND FOUND NO PROBLEMS WITH THE COMPUTER HARDWARE OR SOFTWARE. THE LOG FILE WAS COLLECTED FOR REVIEW BY THE IN HOUSE SOFTWARE ENGINEERING GROUP. THE REVIEW OF THE LOG FILE SHOWED THE FOLLOWING STEPS IN SEQUENCE AT THE END OF THE PROCEDURE. STOP ALL FREEZING BUTTON WAS ACTIVATED. BEGIN FREEZING BUTTONS WERE ACTIVATED. ONE MINUTE LATER, THE "STOP FREEZING BUTTONS" WERE ACTIVATED. THE "THAW BUTTONS" WERE ACTIVATED. CASE ENDED. THIS LOG FILE DEMONSTRATES THAT THE SOFTWARE AND HARDWARE RESPONDED AS IT WAS DESIGNED AND INSTRUCTED TO DO. THE DEVICE WAS INADVERTENTLY ACTIVATED TO FREEZE AFTER THE INITIAL STOP ALL COMMAND, THIS EXPLAINS THE INCREASING ICE SEEN ON ULTRASOUND. THE SECOND "STOP FREEZING" COMMANDS AND THE SUBSEQUENT "THAW" COMMANDS ALL WORKED AS INTENDED AND DESIGNED. SAFEGUARDS IN THE PROCESS AND SYSTEM PREVENTED THIS SITUATION FROM BECOMING MORE SERIOUS. PHYSICIAN MONITORING VIA IMAGING AND AUDIBLE FREEZING GAS SOUNDS ALERTED THE USERS TO THE SITUATION AND IT WAS QUICKLY RESOLVED. THE TECH WILL BE RETRAINED IN THE USE OF THE SOFTWARE AND THE PROCESS. NO OTHER REPORTS OF THIS TYPE OF SITUATION HAVE BEEN REPORTED TO GALIL MEDICAL.

    Description of Event or Problem · 1

    THE TECH IN THE CASE REPORTED THAT DURING A PROCEDURE, THE PRODUCT BEGAN TO FREEZE INSTEAD OF THAW AS WAS REQUESTED BY THE PHYSICIAN. AFTER APPROX 1 MINUTE, THE PHYSICIAN NOTED THE ICE WAS INCREASING ON IMAGING. THE "STOP FREEZING" BUTTONS WERE ACTIVATED AND THE THAW PROCESS WAS STARTED. THE DEVICE THAWED THE FROZEN AREA AND THE PROCEDURE WAS COMPLETED. THE PT WAS REPORTED TO HAVE INCONTINENCE THAT RESOLVED WITH MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESICE CRYOSURGICAL UNIT GEH GALIL MEDICAL FPRCH2047

    Patients

    Seq Age Sex Outcome Treatment
    1