CERTIFIED THERMIRF+

Description of Event or Problem

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.

Additional Manufacturer Narrative

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