BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLICITY III

    MDR report key: 1220766 · Received October 31, 2008

    Report

    Report Number
    1226344-2008-00001
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 31, 2008
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXI
    PMA / PMN Number
    K011387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SUBJECT DEVICE WAS RETURNED TO NEUROTHERM IN 2008, AND EVALUATED IN ACCORDANCE WITH PRE-RELEASE TESTING. THE DEVICE MET ALL PRE-RELEASE CRITERIA, INCLUDING PRE-SHIPMENT TESTS. DURING SIMULATED-USE BENCH TESTS, THE DEVICE'S INSULATED SHAFT BECAME HOT. THE ELECTRODE HANDLE WAS CAREFULLY DISSECTED, AND IT WAS DETERMINED THAT AN UNEXPECTED SOLDER BRIDGE WAS CAUSING A SHORT CIRCUIT BETWEEN THE SECOND AND PROXIMAL ELECTRODES VIA THE HIGH-RESISTANCE THERMOCOUPLE WIRE. THIS CAUSED EXCESSIVE CURRENT TO FLOW IN THE THERMOCOUPLE WIRE AND, CONSEQUENTLY, OVERHEATING. THE HEAT WAS THEN TRANSFERRED TO THE OUTER METAL SHAFT OF THE DEVICE. THIS DEVICE PROBLEM HAS NEVER BEEN PREVIOUSLY OBSERVED, AND THUS, REPRESENTS A UNIQUE OCCURRENCE AMONG THE MANY THOUSANDS OF THIS DEVICE THAT HAVE BEEN MANUFACTURED AND DISTRIBUTED TO THE MEDICAL PROFESSION. TESTING OF ALL EXISTING DEVICE INVENTORY HAS ALSO BEEN CONDUCTED BY NEUROTHERM, AND NO OTHER DEVICE WAS FOUND TO HAVE THIS PROBLEM. THE PRE-RELEASE TESTING PROTOCOL FOR SIMPLICITY III HAS SINCE BEEN MODIFIED TO INCLUDE AN ADD'L INTER-ELECTRODE IMPEDENCE TEST TO ENSURE THAT THIS PARTICULAR ANOMALY DOES NOT RECUR.

    Description of Event or Problem · 1

    ON THE EVENT DATE, NEUROTHERM WAS NOTIFIED ABOUT PT INCIDENT THAT OCCURRED EARLIER THAT DAY, INVOLVING USE OF THE SIMPLICITY III DEVICE ("PROBE"). THE PROBE WAS INSERTED INTO THE PT AT A LATERAL ANGLE FOR THIS PARTICULAR PROCEDURE. DURING THE COURSE OF THE PROCEDURE, THE DOCTOR EXAMINED THE PT, AT WHICH TIME HE NOTICED THAT HER SKIN SURROUNDING THE INSERTION LOCATION WAS SLIGHTLY BLANCHED OR WHITE, INDICATING A BURN. HE PROCEEDED TO DO THE SECOND SIDE OF THE PT, AS IT WAS A BILATERAL PROCEDURE, AND INSERTED A NEW PROBE. HE DISCHARGED THE PT AND SHE SUBSEQUENTLY CALLED HIM TO SAY SHE WAS DOING WELL AND THE MARK IS VERY SMALL AND OF NO SIGNIFICANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLICITY III DISPOSABLE MULTI-ELECTRODE RF PROBE GXI NEUROTHERM, INC. REF RFDE-SI 080831-3B

    Patients

    Seq Age Sex Outcome Treatment
    1