INFINITY ERCP SAMPLING DEVICE

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT WAS REQUESTED BACK FOR EVALUATION HOWEVER, THE DEVICE WAS NOT AVAILABLE. AS THE DEVICE IS NOT AVAILABLE FOR EVALUATION, A ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE PACKET (IFU 732074) INCLUDES THE FOLLOWING STATEMENTS, "PRIOR TO USE: TIGHTEN THE LUER LOCK BETWEEN THE WHITE HANDLE AND THE GRAY Y-PORT. HOLD THE PROXIMAL DEVICE END IN ONE HAND, AND THE DISTAL SHEATH END IN THE OPPOSITE HAND. RINSE THE BRUSH WITH STERILE WATER. ACTUATE THE HANDLE SEVERAL TIMES TO BE SURE THE BRUSH FUNCTIONS PROPERLY. IF THE UNIT DOES NOT FUNCTION PROPERLY, OR THERE IS EVIDENCE OF DAMAGE (E.G., BENT BRUSH, BENT BRUSH STEM, KINKED CATHETER), DO NOT USE THIS PRODUCT AND CONTACT YOUR LOCAL PRODUCT SPECIALIST. WARNINGS AND PRECAUTIONS: DO NOT FORCE THE BRUSH THROUGH THE ENDOSCOPE'S CHANNEL. REDUCE ANGULATION OF THE SCOPE IF RESISTANCE IS MET." STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE INFINITY ERCP SAMPLING DEVICE HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT DURING A PATIENT PROCEDURE, THE END OF THE BRUSH DETACHED FROM THEIR INFINITY ERCP SAMPLING DEVICE. THE BRUSH WAS FULLY RETAINED AND RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.