Additional Manufacturer Narrative · 1
WHEN THE SITE WAS CONTACTED, THEY INDICATED THAT THEY WOULD SUPPLY NO FURTHER INFO. THE IFU WARNS: NON-TRADITIONAL PROCEDURES THAT UTILIZE HIGH CURRENT, LONG DUTY CYCLES, OR BOTH (FOR EXAMPLE: TISSUE LESIONING, TISSUE ABLATION, TISSUE VAPORIZATION, AND PROCEDURES IN WHICH CONDUCTIVE FLUIDS SUCH AS SALINE OR LACTATED. RINGER'S SOLUTION ARE INTRODUCED INTO THE SURGICAL SITE FOR DISTENTION OR TO CONDUCT THE RF CURRENT) INCREASE THE RISK OF EXCESSIVE HEATING UNDER A FULLY APPLIED RETURN ELECTRODE TO THE POINT OF INJURING THE PT. USE OF MORE THAN ONE PT RETURN ELECTRODE MAY HELP MITIGATE THE INCREASED RISK. IN OUR CUSTOMER RESPONSE LETTER, WE INCLUDED A COPY OF A HOTLINE BULLETIN EXPLAINING THE IMPACT OF HIGH ENERGY DEVICES WITH TRADITIONAL PT RETURN ELECTRODES.