Description of Event or Problem · 0
I AM REPORTING A REPRODUCIBLE ADVERSE EVENT ASSOCIATED WITH THE INMODE EMPOWERRF DEVICE DURING NORMAL AND INTENDED OPERATION. WHEN HOLDING THE HANDPIECE DURING ACTIVE RF ENERGY DELIVERY, I EXPERIENCE VULVAR BURNING PAIN WITHIN APPROXIMATELY ONE HOUR OF USE. THE PAIN IS PROVOKED, CONSISTENT, AND REPRODUCIBLE, OCCURRING ONLY AFTER DEVICE ACTIVATION AND AFTER I HAVE BEEN IN PHYSICAL CONTACT WITH THE HANDPIECE. SYMPTOMS PERSIST FOR APPROXIMATELY 3¿4 DAYS FOLLOWING EACH EXPOSURE. PATIENTS TREATED WITH THE DEVICE DO NOT EXPERIENCE THESE SYMPTOMS. THIS EFFECT IS CONSISTENT ACROSS MULTIPLE USES AND PERSISTS DESPITE ADHERENCE TO ALL MANUFACTURER GUIDELINES, PROPER TECHNIQUE, AND STANDARD OPERATING CONDITIONS. I HAVE A PRIOR HISTORY OF VULVODYNIA THAT HAD COMPLETELY RESOLVED FOLLOWING MULTIPLE SURGERIES, MEDICATIONS, AND IMPLANTATION OF A SPINAL CORD STIMULATOR (EXPLANTED). THIS CONDITION HAD BEEN IN FULL REMISSION FOR OVER 15 YEARS PRIOR TO USE OF THIS DEVICE. THE RECURRENCE OF SIGNIFICANT PAIN IN DIRECT TEMPORAL ASSOCIATION WITH DEVICE OPERATION RAISES CONCERN FOR UNINTENDED RF EXPOSURE, ELECTRICAL CURRENT LEAKAGE, GROUNDING ISSUES, OR OTHER DEVICE MALFUNCTION AFFECTING THE OPERATOR. THE PAIN IS NOT PRESENT OUTSIDE OF BEING PROVOKED DURING DEVICE USE. I HAVE NOTIFIED THE MANUFACTURER (INMODE LTD.), BUT NO INVESTIGATION, DEVICE EVALUATION, OR REMEDIAL ACTION HAS BEEN INITIATED. DESPITE THESE EFFECTS, I HAVE CONTINUED TO USE THE DEVICE IN ORDER TO MAINTAIN PATIENT TREATMENTS AND MEET FINANCIAL OBLIGATIONS ASSOCIATED WITH ITS PURCHASE. I HAVE NOTIFIED THE MANUFACTURER (INMODE LTD.) AND THE FINANCING COMPANY (B)(6), BUT NO INVESTIGATION, DEVICE EVALUATION, OR REMEDIAL ACTION HAS BEEN INITIATED. DUE TO THE REPRODUCIBLE ADVERSE SYMPTOMS, THE DEVICE IS UNSAFE FOR OPERATOR USE UNDER NORMAL CONDITIONS.