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Patient 1
THE BIOSHIELD IRRIGATOR BIOPSY VALVE IS USED TO COVER THE OPENING TO THE BIOPSY/SUCTION CHANNEL INLET OF A GASTROINTESTINAL ENDOSCOPE. THE BIOSHIELD IRRIGATOR BIOPSY VALVE PROVIDES ACCESS FOR ENDOSCOPIC DEVICE PASSAGE AND EXCHANGE, HELPS MAINTAIN INSUFFLATION AND MINIMIZES LEAKAGE OF BIOMATERIAL FROM THE BIOPSY PORT THROUGHOUT THE GASTROINTESTINAL ENDOSCOPIC PROCEDURE. THE BIOSHIELD IRRIGATOR WILL ALSO ALLOW FOR REMOTE IRRIGATION VIA AN ATTACHED IRRIGATION LINE. US ENDOSCOPY RECEIVED A REPORT REGARDING A BIOSHIELD IRRIGATOR BIOPSY VALVE. THE REPORT INDICATED THAT THE BIOSHIELD IRRIGATOR BIOPSY VALVE SPRAYED FLUID DURING THE PROCEDURE. THE STAFF WORE APPROPRIATE PPE AND DID NOT COME INTO DIRECT CONTACT WITH THE LEAKED FLUID. THERE WAS NO HARM TO THE PATIENT OR USER AS A RESULT OF THE LEAKING. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND INDICATED THAT ALL IN-PROCESS AND FINAL INSPECTIONS WERE PERFORMED AND ACCEPTABLE RESULTS WERE DOCUMENTED. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. INFORMATION INCLUDED IN THE INSTRUCTIONS FOR USE INCLUDES: "IRRIGATING THROUGH THE BIOSHIELD BIOPSY VALVE'S IRRIGATION LINE WITH A DEVICE IN THE BIOPSY CHANNEL REQUIRES SUFFICIENT SPACE BETWEEN THE DIAMETER OF THE DEVICE AND THE DIAMETER OF THE ENDOSCOPE'S CHANNEL. ADEQUATE SPACE IS REQUIRED TO ALLOW FLUID TO PASS FREELY AT A MODERATE PRESSURE SO THAT THE VALVE CONNECTIONS DO NOT LEAK. LEAKAGE THROUGH NON-SHEATHED SPRING-COILED DEVICES SUCH AS BIOPSY FORCEPS WILL OCCUR IF IRRIGATION IS PERFORMED WHILE THE NON-SHEATHED DEVICE REMAINS IN THE BIOPSY CHANNEL. DO NOT LEAVE A DEVICE HANGING FROM THE VALVE. DOING SO CAN CAUSE THE CREATION OF A LAGER VALVE SLIT/HOLE THAT MAY CAUSE LEAKAGE. IF LEAKAGE OCCURS, A STERILE GAUZE SHOULD BE USED TO COVER THE VALVE." IF ADDITIONAL INFORMATION BECAUSE AVAILABLE THIS REPORT WILL BE UPDATED. NOT RETURNED TO MANUFACTURER.