OLYMPUS ENDOSCOPES

Description of Event or Problem

OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS NOT REPROCESSING THEIR ENDOSCOPES IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USERS WERE REPORTEDLY NOT PERFORMING BEDSIDE CLEANING IMMEDIATELY AFTER EACH PROCEDURES, AND NOT FULLY IMMERSING THE SCOPE IN THE DISINFECTANT SOLUTION. THERE WERE NO REPORTS OF ANY PT INFECTIONS OR CROSS CONTAMINATION.

Additional Manufacturer Narrative

THERE WAS NO DEVICE RETURNED TO OLYMPUS FOR EVALUATION. BASED UPON THE INFO PROVIDED, THE USER FACILITY WAS NOT REPROCESSING THEIR ENDOSCOPES IN ACCORDANCE TO THE INSTRUCTIONS FOR USE. THE USER FACILITY HAD NOT BEEN REPROCESSING THE ENDOSCOPES IN AN AUTOMATED ENDOSCOPE PREPROCESSOR (AER) BUT THE USER FACILITY WAS REPORTEDLY SOAKING THEIR ENDOSCOPES IN (B)(4), BUT THE ENDOSCOPE WAS NOT ENTIRELY IMMERSED IN THE DISINFECTANT SOLUTION DUE TO THE CYLINDER THEY USED. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST (ESS) HAS VISITED THE USER FACILITY AND PROVIDED IN-SERVICE TRAINING TO THE USER FACILITY PERSONNEL REGARDING THE APPROPRIATE REPROCESSING, TRANSPORT AND STORAGE OF ENDOSCOPE. THE ESS HAS ALSO PROVIDED THE USER FACILITY REPROCESSING EDUCATIONAL MATERIALS FOR ADDITIONAL REFERENCES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.