BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPLICITY III

    MDR report key: 1486654 · Received September 26, 2009

    Report

    Report Number
    1226344-2009-00001
    Event Type
    Other
    Date Received
    September 26, 2009
    Date of Event
    August 27, 2009
    Report Date
    September 25, 2009
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXI
    PMA / PMN Number
    K011387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A DISCUSSION WITH THE FACILITY, IT IS APPARENT THAT THE PROBE WAS MET WITH RESISTANCE DURING ADVANCEMENT AND AN ADDITIONAL ATTEMPT OF ADVANCEMENT WAS MADE REGARDLESS. IT IS THEREFORE UNCLEAR WHETHER THE DISLODGING OF THE TIP WAS CAUSED BY PRODUCT DEFECT OR PRODUCT MISUSE. (B)(4). FURTHER, REVIEW OF OUR MANUFACTURING RECORDS SHOW THAT NO CHANGES HAVE BEEN MADE TO THE TIP WELDING PROCESS OF THIS DEVICE. FROM THESE FACTS IT IS CLEAR THAT THIS IS AN ISOLATED INCIDENT. BASED ON NEUROTHERM CONSULTATIONS WITH AN INDEPENDENT CLINICAL EXPERT, NEUROTHERM BELIEVES THAT THERE IS NO HEALTH HAZARD ASSOCIATED WITH THE TIP REMAINING IN THE PT FOLLOWING THIS RF ABLATION PROCEDURE. THIS IS SUPPORTED BY THE FACT THAT THE PT INVOLVED HAS NOT EXHIBITED ANY SIGNS OF ILLNESS, INFECTION, OR DISCOMFORT AS A RESULT. MOREOVER, THE SURGICAL GRADE NON-PYROGENIC MATERIAL USED IN THE PROBE IS SIMILAR TO OTHER NON-PYROGENIC MATERIALS USED IN METAL CLIPS THAT ARE ROUTINELY EMPLOYED FOR A VARIETY OF GENERAL SURGICAL PROCEDURES, AND THAT ARE ALLOWED TO REMAIN IN A PT AFTER SURGERY WITHOUT TRIGGERING ANY IMMUNE RESPONSE OR LOCAL OR SYSTEM INFECTION. NEUROTHERM CONCLUDES THAT BASED ON THE EXTRAORDINARY UNLIKELIHOOD OF THIS EVENT RECURRING COUPLED WITH THE HEALTH HAZARD ANALYSIS DESCRIBED ABOVE THAT NO FURTHER ACTIONS ARE WARRANTED.

    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. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE PROBE COULD NOT BE EASILY ADVANCED. HE SLIGHTLY WITHDREW THE PROBE AND THEN TRIED TO ADVANCE IT AGAIN WITHOUT SUCCESS. AT THIS TIME, HE REMOVED THE PROBE FROM THE PT AND SAW THAT THE TIP HAD BROKEN OFF. THE PT WAS INFORMED OF THE INCIDENT, BUT DECIDED TO NOT HAVE THE TIP REMOVED BASED ON THE PHYSICIAN'S RECOMMENDATION. IN FOLLOW UP WITH THE FACILITY, 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. RFDE-SI 090331-1A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR