OLYMPUS ENDOSCOPES

Additional Manufacturer Narrative

NO DEVICES WERE RETURNED TO OLYMPUS FOR EVAL IN ASSOCIATION WITH THIS REPORT. THERE WAS NO ALLEGATION OF ANY DEFICIENCIES IN THE PRODUCT WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THIS REPORT. BASED UPON THE INFO PROVIDED, THE USERS WERE NOT REPROCESSING THE DEVICES IN ACCORDANCE WITH THE DEVICE INSTRUCTION MANUAL. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS PROVIDED IN-SERVICE TRAINING AND EDUCATIONAL MATERIALS TO THE USER FACILITY STAFF ON APPROPRIATE REPROCESSING OF ENDOSCOPES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT USER FACILITY PERSONNEL WERE PERFORMING MANUAL CLEANING OF ENDOSCOPES, BUT NOT APPROPRIATELY PRE-CLEANING, BRUSHING OR FLUSHING THE CHANNELS OF THE SUBJECT DEVICE, NOR SUFFICIENTLY RINSING FOLLOWING DISINFECTION. FURTHERMORE, THE USERS AT THE FACILITY WERE REPORTEDLY NOT SOAKING THE ENTIRE ENDOSCOPE INTO THE DISINFECTANT SOLUTION. TO DATE, THERE HAVE BEEN NO REPORTS OF ADVERSE EVENTS ASSOCIATED WITH THIS REPORT.