SCOPE

Additional Manufacturer Narrative

THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING, AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), DURING REPROCESSING, THE ENDOSCOPE REPROCESSOR EXHIBITED ERROR E05 INDICATING CLEANING FLUID LEVEL WAS TOO HIGH. WHEN AN OLYMPUS FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY, THE FSE NOTICED CUSTOMER NOT USING ENDOQUICK AND WERE USING A BLUE DETERGENT OF SOME SORT. THIS REPORT IS FOR AN UNKNOWN SCOPE THAT WAS REPROCESSED USING INCORRECT DETERGENT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. PATIENT IDENTIFIER (B)(6) CAPTURES COMPLAINT ON THE REPROCESSOR THAT WAS USING INCORRECT DETERGENT. (MODEL NO. OER-PRO, SERIAL NO. (B)(4)).

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE MODEL AND SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE USER DID NOT READ INSTRUCTIONS FOR USE (IFU) OR DEVIATED FROM THE IFU INTENTIONALLY AND USED DETERGENT OTHER THAN OLYMPUS DESIGNATION. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.