THD S. P. A. - VIA INDUSTRIA

Description of Event or Problem

AFTER TRANSANAL HEMORRHOIDAL DEARTERIALIZATION (THD) PROCEDURE UTILIZING THE REVOLUTION THD MACHINE, THE SURGEON NOTICED 2 BLISTERS ON THE RIGHT SIDE OF THE PT'S RECTUM AND 2 BLISTERS ON THE LEFT SIDE OF THE RECTUM. THE NEW REVOLUTION (VA. EVOLUTION) THD EQUIPMENT CAN ONLY HE USED WITH THE LIGHT CORD TOUCHING THE PT'S SKIN. THE THD REP REVEALED THE COMPANY WAS AWARE THERE WAS A RISK TO PT'S SKIN AS A SIMILAR EVENT HAD OCCURRED AT ANOTHER HOSPITAL IN THE AREA. PER THE REP, A COUPLE MDS (NOT ALL WERE CONTACTED TO INFORM THEM OF THIS RISK, BUT NOT THE HOSPITAL, ALLOWING THIS SUBSEQUENT EVENT TO OCCUR. A NEW HAND PIECE IS BEING SENT TO REPLACE THE EXISTING VERSION.