BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPLICITY III

    MDR report key: 1258191 · Received December 2, 2008

    Report

    Report Number
    1226344-2008-00002
    Event Type
    Other
    Date Received
    December 2, 2008
    Date of Event
    June 17, 2008
    Report Date
    December 1, 2008
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXI
    PMA / PMN Number
    K011387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH PHYSICIAN MISUSE OF THE DEVICE WAS THE CAUSE OF THE EVENT DESCRIBED ABOVE, NEUROTHERM DETERMINED AFTER CONSULTATION WITH FDA THAT SUBMITTING AN MDR WAS APPROPRIATE. EVALUATION SUMMARY: THE SUBJECT SIMPLICITY RF PROBE (THE "PROBE") WAS RETURNED TO NEUROTHERM ON JUNE 18, 2008 AND EVALUATED. THE COMPANY CONDUCTED A VISUAL INSPECTION OF THE PROBE AND DETERMINED THAT THE PROBE'S SEMI-RIGID SHAFT HAD BEEN BENT. THE BENDING HAD CAUSED THE PROBE SHAFT TO KINK, WHICH COMPROMISED THE INTEGRITY OF THE DISTAL ELECTRODE, CAUSING IT TO DETACH FROM THE PROBE DURING USE. UPON QUESTIONING, THE PHYSICIAN WHO HAD USED THE PROBE ADMITTED THAT HE BENT IT PRIOR TO USE DESPITE WARNINGS IN THE PRODUCT LABELING AGAINST SUCH PRACTICE. THE PRODUCT LABELING HAS SINCE BEEN MODIFIED TO STRENGTHEN THE WARNING AGAINST BENDING THE PROBE.

    Description of Event or Problem · 1

    NEUROTHERM WAS NOTIFIED ABOUT AN INCIDENT INVOLVING THE USE OF THE SIMPLICITY III DEVICE ("PROBE") DURING A MEDICAL PROCEDURE. THE PROBE WAS INSERTED INTO THE PT DURING THE NORMAL COURSE OF TREATMENT. WHEN THE PHYSICIAN LATER REMOVED THE PROBE FROM THE PT HE NOTICED THAT THE PROBE'S DISTAL ELECTRODE HAD DETACHED FROM THE PROBE'S SHAFT AND WAS STILL IN THE PT. THE PT WAS INFORMED OF THE INCIDENT BUT DECIDED NOT TO HAVE THE ELECTRODE REMOVED. THE PHYSICIAN STATED THAT HE BENT THE PROBE PRIOR TO USE, CONTRARY TO CAUTIONARY STATEMENTS ON THE PRODUCT LABEL ADVISING AGAINST BENDING OF THE PROBE. THE PROCEDURE WAS CONSIDERED TO BE CLINICALLY SUCCESSFUL AND, IN FOLLOW-UP, THE PT HAS NOT REPORTED ANY COMPLICATIONS OR SIDE EFFECTS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1