UNKNOWN

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT A MOLD WAS GROWING IN THE WATER SUPPLY LINE FROM THE EXTERNAL PRE-FILTER TO THE AUTOMATED ENDOSCOPE REPROCESSOR (AER). THE ISSUE WAS FOUND DURING REPROCESSING, THE CUSTOMER PROVIDED ADDITIONAL DETAILS STATING THAT THE MOLD WAS IDENTIFIED ON THE EXTERIOR (AND PRESUMABLY INTERIOR) OF THE WATER LINE AT THE POINT OF CONNECTION JUST AFTER THE PRE-FILTERS AND BEFORE THE INTERNAL FILTERS. THE SCOPES REPROCESSED AND RINSED IN THE OER PRO UNIT WERE USED ON SEVERAL PATIENTS OVER THE COURSE OF AN UNKNOWN TIME PERIOD. ONCE THE TUBING AND CONNECTIONS HAVE BEEN REPLACED, THE WATER LINE WILL RUN A DISINFECTANT CYCLE PER OLYMPUS RECOMMENDATION AND REPROCESS THE SCOPES. NO PATIENT INJURY, DEATH, OR INFECTION HAS BEEN REPORTED AT THIS TIME. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6) (SCOPE), (B)(6) (AER)

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED FOR ADDITIONAL DETAILS RELATING TO THE PATIENT EVENTS, THE PRODUCT MODEL/SERIAL NUMBER AND THE CUSTOMER¿S CULTURE TEST RESULTS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. DESPITE GOOD FAITH ATTEMPTS THE USER CULTURE RESULTS AND CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES WERE NOT SHARED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION AND BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED, THE REPORTED EVENT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE PRE-FILTER WAS NOT INSTALLED CORRECTLY OR THE INTERNAL FILTER WAS NOT REPLACED PROPERLY CAUSING MOLD INSIDE THE PRE-FILTER LEADING TO THE EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.