UNKNOWN OLYMPUS SCOPE

Additional Manufacturer Narrative

OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) PROVIDED THE REPROCESSING MANUAL TO THE CUSTOMER. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION FROM THE CUSTOMER ARE IN PROGRESS. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

Description of Event or Problem

THE CUSTOMER REPORTED THE AN UNKNOWN SCOPE WAS REPROCESSED INCORRECTLY. ASPIRATION WAS NOT DONE BY THE CUSTOMER DURING MANUAL CLEANING, BUT THEY THEN STARTED USING A SUCTION TOWER. THE CUSTOMER INQUIRED IF SUCTION COULD BE DONE USING A SYRINGE INSTEAD OF A SUCTION MACHINE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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, IT¿S LIKELY THE CUSTOMER¿S DEVICE HANDLING AND REPROCESSING STEPS DIFFERED FROM THE OLYMPUS INSTRUCTIONS FOR USE. THE FINAL ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS IN REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE. (THE MODEL TYPE OF THE SUBJECT DEVICE WAS UNKNOWN; THEREFORE THE GI-SERIES MODEL DEVICE WAS USED.) OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.