BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTIFIED THERMIRF+

    MDR report key: 18167239 · Received November 19, 2023

    Report

    Report Number
    3006404071-2023-00006
    Event Type
    Injury
    Date Received
    November 19, 2023
    Date of Event
    April 12, 2023
    Report Date
    November 19, 2023
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    DWG
    UDI-DI
    00817771029181
    PMA / PMN Number
    K130689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED FOR EVALUATION AS IT IS DETERMINED THAT IT IS NOT THE CULPRIT. ACCESSORY ELECTRODE BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    SPINESMITH REPRESENTATIVE REPORTED THAT THE ACCOUNT INFORMED THEM THAT THEIR RF+ THERMISMOOTH HANDPIECE IS HEATING UP TOO QUICKLY AND CAUSING (SPARKING AND ARCHING) WHEN IN CONTACT WITH THE PATIENT AND THEY ARE UNABLE TO DO PROCEDURES. SPINESMITH SENIOR CLINICAL SPECIALIST CONTACTED THE CUSTOMER FOR MORE INFORMATION. SPECIALIST REPORTED THAT AFTER SPEAKING WITH THE PRACTICE, SHE EXPLAINED THAT DURING THE PROCEDURE, THE PROBE TO SKIN CONTACT MAY BE DISRUPTED (FOR EXAMPLE IF DURING THE PROCEDURE THE PROBE WAS LIFTED FORM THE SKIN SURFACE OR IF THERE IS HAIR/DEBRIS IN THE WAY OF THE CONTACT SURFACE OF THE ELECTRODE), A SENSATION CAN OCCUR THAT FEELS LIKE PULLING/TIGHTENING ON THE SKIN OR A SHOCK. SPECIALIST DID REQUEST THE RETURN OF THE ELECTRODE USED FOR EVALUATION. CONTINUED CONVERSATION WITH OFFICE STAFF VERIFIED THAT WHILE PERFORMING THE PROCEDURE WITH THE THERMISMOOTH HANDPIECE, THERE WAS NO VISUAL "SPARKING" OR "ARCHING" OBSERVED RATHER THAT THE PATIENT DESCRIBED DISCOMFORT AS A "PULLING" OR "TIGHT" SENSATION WAS OCCURING. NO INJURIES WERE OBSERVED BY THE PHYSICIAN AND THEY HAVE SINCE HAD NO ISSUES. ELECTRODE WILL BE RETURNED FOR FINAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925372 CERTIFIED THERMIRF+ RF GENERATOR DWG SPINESMITH HOLDINGS,LLC CERTIFIED THERMIRF+ 00817771029181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other #2130AC GROUNDING PAD| RFE-10-D-G2 ELECTRODE