BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLICITY III

    MDR report key: 1281494 · Received December 24, 2008

    Report

    Report Number
    1226344-2008-00004
    Event Type
    Malfunction
    Date Received
    December 24, 2008
    Date of Event
    August 14, 2008
    Report Date
    December 23, 2008
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXI
    PMA / PMN Number
    K011387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER LEARNING SECONDHAND FROM A SALES REPRESENTATIVE THAT AN INCIDENT INVOLVING A SIMPLICITY III PROBE MAY HAVE OCCURRED, NEUROTHERM MADE NUMEROUS ATTEMPTS OVER SEVERAL MONTHS TO CONTACT THE TREATING PHYSICIAN IN ORDER TO EVALUATE THE MATTER. ULTIMATELY, THE LACK OF AVAILABLE INFORMATION NECESSITATED THAT A COMPANY REPRESENTATIVE MAKE A SPECIAL TRIP TO INTERVIEW THE PHYSICIAN AND LEARN WHAT OCCURRED. DURING THIS MEETING, THE COMPANY LEARNED THAT THE PROBE HAD BEEN DISCARDED FOLLOWING THE TREATMENT AND NEUROTHERM WAS NOT ABLE TO EVALUATE THE PROBE IN QUESTION TO DETERMINE THE EXACT CAUSE OF THE MALFUNCTION. IN AN ABUNDANCE OF CAUTION, NEUROTHERM REMOVED PRODUCTION LOTS 080630-1B AND 080630-1C FROM THE MARKET. IN ADDITION, MINOR MANUFACTURING CHANGES WERE INITIATED FOR ALL FUTURE PRODUCTION LOTS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT HE PLACED THE PROBE IN THE PATIENT AND NOTICED THAT THE TEMPERATURE OF ONE OF THE PROBE'S ELECTRODES FAILED TO REGISTER. THE PHYSICIAN THEN REMOVED THE PROBE AND NOTICED THAT ONE OF THE PROBE'S ELECTRODES WAS MISSING FROM THE DEVICE. THE PHYSICIAN THEN INSERTED A SECOND PROBE AND COMPLETED THE MEDICAL PROCEDURE WITHOUT INCIDENT. AFTER COMPLETING THE PROCEDURE, THE PHYSICIAN USED FLUOROSCOPY IMAGING, WHICH APPEARED TO CONFIRM THAT THE MISSING ELECTRODE WAS STILL IN THE PATIENT IN AN INNOCUOUS PORTION OF THE SACRAL AREA. THE PATIENT OPTED NOT TO HAVE THE PROBE REMOVED. TO DATE, THE PATIENT HAS NOT REPORTED ANY ILLNESS, INJURY OR COMPLICATIONS ASSOCIATED WITH THE INCIDENT.

    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 080630-(1B OR 1C)

    Patients

    Seq Age Sex Outcome Treatment
    1