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Patient 1
THE EXACTO COLD SNARE IS INTENDED TO BE USED WITHOUT DIATHERMIC ENERGY FOR THE ENDOSCOPIC RESECTION OF POLYP TISSUE IN THE GASTROINTESTINAL TRACT. THE USER FACILITY PERSONNEL REPORTED THE LOOP WAS PARTIALLY SEPARATED FROM THE CONTROL WIRE UPON FIRST DEPLOYMENT OF THE SNARE WHILE INSIDE THE PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE DEVICES WERE MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. THE DEVICE SUBJECT OF THIS EVENT WAS NOT RETURNED TO US ENDOSCOPY FOR EVALUATION. THE USER FACILITY PERSONNEL MISTAKENLY RETAINED AND RETURNED THE SECOND, INTACT SNARE. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING STATEMENTS: "PRIOR TO CLINICAL USE, INSPECT AND FAMILIARIZE YOURSELF WITH THE DEVICE. IF THERE IS EVIDENCE OF DAMAGE, DO NOT USE THIS PRODUCT AND CONTACT YOUR LOCAL PRODUCT SPECIALIST. REMOVE THE DEVICE FROM THE PACKAGE AND UNCOIL THE ENTIRE DEVICE AND DRAPE IN A "U" SHAPED CONFIGURATION, HOLDING THE PROXIMAL END IN ONE HAND AND THE DISTAL SHEATH IN THE OPPOSITE HAND. MOVE THE FINGER RINGS BACK AND FORTH TO CONFIRM THAT THE SNARE LOOP OPENS AND CLOSES SMOOTHLY PRIOR TO INSERTING INTO THE ENDOSCOPE. ENSURE THE SNARE LOOP IS FULLY RETRACTED INTO THE CATHETER PRIOR TO INSERTION INTO THE ENDOSCOPE. SHORT STROKES, 1"-1.5" (2.5CM - 3.8CM) IN LENGTH, ARE RECOMMENDED THROUGHOUT DEVICE PASSAGE TO AVOID SHEATH KINKING. THE FOLLOWING CONDITIONS MAY NOT ALLOW THE DEVICE TO FUNCTION PROPERLY OR CAUSE PATIENT INJURY: ATTEMPTING TO ADVANCE THE HANDLE TO THE OPEN POSITION WITH TOO MUCH SPEED OR FORCE, ATTEMPTING TO PASS OR OPEN THE DEVICE IN AN EXTREMELY ARTICULATED ENDOSCOPE, ATTEMPTING TO ACTUATE THE DEVICE IN AN EXTREMELY COILED POSITION AND/OR, ATTEMPTING TO ACTUATE THE DEVICE WHEN THE HANDLE IS AT AN ACUTE ANGLE IN RELATION TO THE SHEATH." THE USER FACILITY HAS DECLINED OFFER OF IN-SERVICE TRAINING.