BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEEDNET ICESEED NEEDLE

    MDR report key: 1873761 · Received July 28, 2010

    Report

    Report Number
    9616793-2010-00009
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 30, 2010
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K060144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLES WERE NOT RETURNED; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED. GALIL IFU INSTRUCTS THE USERS TO SET UP THE SYSTEM AND TEST THE NEEDLES PRIOR TO BEGINNING A PROCEDURE TO ENSURE PROPER FUNCTIONALITY. PROVIDED THE PATIENT IS NOT UNDER ANESTHESIA, THERE IS NO RISK TO THE PATIENT. SINCE THE PATIENT WAS UNDER ANESTHESIA, THE ONLY RISKS TO THE PATIENT ARE THOSE ASSOCIATED WITH ANESTHESIA. THE CRYOTHERAPY PROCEDURE WAS NOT STARTED AND, THEREFORE, THERE WAS NO THERAPY RELATED RISKS TO THE PATIENT. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS UNDER ANESTHESIA: IT WAS REPORTED THAT THE POWER WOULD NOT TURN ON; THE PANEL OF THE UNIT WAS REMOVED AND THE POWER CORD WAS PULLED BACK IN AND THE SYSTEM FUNCTIONED PROPERLY. IT WAS REPORTED THAT THE BARCODE DID NOT WORK. ANOTHER BAR CODE WAS PROVIDED AND THE SYSTEM FUNCTIONED PROPERLY. IT WAS REPORTED THAT THE SYSTEM MONITOR INDICATED, THE GAS PRESSURE WAS TOO HIGH, HOWEVER, THE GAS GAUGES WERE CHECKED AND THE GAS PRESSURE WAS NOT TOO HIGH. IT WAS REPORTED THAT TESTING OF THE PROBES (NEEDLES) WAS TRIED ON THREE CHANNELS WITH NO ICE FORMATION ON ANY CHANNELS. THE DOCTOR DECIDED TO NOT USE CRYO BECAUSE, THEY WERE UNABLE TO TEST THE PROBES. THE DOCTOR USED A DIFFERENT TREATMENT FOR THE FACIAL NEUROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEEDNET ICESEED NEEDLE CRYOSURGICAL UNIT, ACCESSORIES GEH GALIL MEDICAL LTD. FPRPR3220 G5794-006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK