OLYMPUS ENDOSCOPES

Description of Event or Problem

OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS NOT REPROCESSING THE ENDOSCOPES IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY PERSONNEL WERE REPORTEDLY NOT PERFORMING ANY OF THE PRE-CLEANING STEPS, AND WAS NOT LEAK TESTING. ADDITIONALLY, THE USER FACILITY REPORTEDLY WAS NOT USING THE SUCTION CLEANING ADAPTOR AND WOULD REUSE SINGLE-USE CLEANING BRUSHES. THE USER FACILITY REPORTEDLY WAS NOT USING THE CHANNEL OPENING BRUSH AND WAS NOT REPROCESSING THE AUXILIARY WATER TUBE WHICH REPORTEDLY WAS USED IN PATIENT PROCEDURES FOR OVER ONE YEAR WITHOUT BEING REPROCESSED. THE USER FACILITY REPORTEDLY DID NOT HAVE AUTOMATED ENDOSCOPE REPROCESSORS ON SITE WITH REPROCESSING PERFORMED ONLY MANUALLY. THERE HAD BEEN NO REPORT OF INFECTION AND CROSS CONTAMINATION.

Additional Manufacturer Narrative

AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS VISITED THIS FACILITY AND PROVIDED IN-SERVICE TRAINING AND EDUCATIONAL MATERIALS REGARDING THE APPROPRIATE REPROCESSING OF ENDOSCOPES. NO PRODUCTS WERE RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS INSTRUCTION AND REPROCESSING MANUALS PROVIDE DETAILED INFORMATION ON HOW TO REPROCESS ENDOSCOPES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.