DEFENDO VALVE AND CONNECTOR KIT

Additional Manufacturer Narrative

THE DEFENDO DISPOSABLE AIR/WATER VALVES SUBJECT OF THE REPORTED EVENT WERE NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, A ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE STATES, "ATTACH THE SINGLE USE AIR/WATER VALVE TO THE ENDOSCOPE'S AIR/WATER PORT. PUSH DOWN, TWISTING SLIGHTLY BACK AND FORTH, UNTIL THE VALVE ENGAGES. PRIOR TO THE PROCEDURE, DEPRESS SINGLE USE AIR/WATER VALVE TO PRIME AIR/WATER CHANNEL. ATTACH THE SINGLE USE SUCTION VALVE TO THE ENDOSCOPE'S SUCTION PORT. PUSH DOWN, TWISTING SLIGHTLY BACK AND FORTH, UNTIL THE VALVE ENGAGES. PRIOR TO THE PROCEDURE, TURN ON SUCTION SOURCE AND CHECK SUCTION BY DEPRESSING THE SINGLE USE SUCTION VALVE." STERIS COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE DEFENDO DISPOSABLE AIR/WATER VALVE, SPECIFICALLY THE IMPORTANCE OF PROPERLY ENGAGING THE VALVE TO THE ENDOSCOPE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WATER WAS LEAKING FROM THEIR DEFENDO DISPOSABLE AIR/WATER VALVES. USER FACILITY PERSONNEL CHANGED THE VALVES, TUBING, AND LOWERED THE WATER LEVEL WITHIN THEIR DEFENDO DISPOSABLE AIR/WATER VALVE RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.