UNKNOWN

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS NOT SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHEN STAFF COLLECTED WATER FROM THE CLEANING TANK OF THE ENDOSCOPE REPROCESSOR, A MOLD-LIKE FOREIGN OBJECT CAME OUT OF THE WATER SUPPLY PORT. THE REPROCESSOR HAD NOT BEEN USED RECENTLY. THE WATER SUPPLY PIPE WAS DISINFECTED AND FOREIGN OBJECTS WERE RECOVERED. AN OLYMPUS TECHNICIAN VISITED THE SITE AND FOUND THAT WATER SUPPLY PIPELINE DISINFECTION WAS NOT PERFORMED DURING THE WATER FILTER CHANGE. IT WAS DETERMINED THAT AN ENDOSCOPE THAT WAS INCORRECTLY REPROCESSED MAY HAVE BEEN USED ON A PATIENT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS FOR THE ENDOSCOPE. THE OER-4 ENDOSCOPE REPROCESSOR IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY INSTRUCTIONS WERE NOT FOLLOWED AND THE DEVICE WAS NOT REPROCESSED CORRECTLY. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "CHAPTER 7 MONTHLY OR WEEKLY WORK AS NEEDED 7.3 DISINFECTION OF WATER SUPPLY LINES IN THE FOLLOWING CASES, BE SURE TO DISINFECT THE WATER SUPPLY PIPE. ¿ WHEN USING THE DEVICE FOR THE FIRST TIME (AFTER SETTING THE WATER FILTER) ¿ WHEN THE WATER FILTER IS REPLACED ¿ WHEN IT IS DETERMINED THAT VARIOUS BACTERIA HAVE ENTERED THE WATER SUPPLY PIPE ¿ WHEN THE DEVICE HAS BEEN STORED FOR A LONG PERIOD OF TIME AND THEN PUT BACK INTO USE. ·WHEN DISINFECTING WATER SUPPLY PIPES, USE AN ACESIDE CHECKER TO CHECK THE EFFECTIVENESS OF THE DISINFECTANT. IF IT IS DETERMINED THAT THE SPECIFIED DISINFECTION EFFECT IS NOT ACHIEVED, THE REPLACE THE VENOM. IF THE WATER SUPPLY PIPE IS DISINFECTED AS IT IS, THE SPECIFIED DISINFECTION EFFECT MAY NOT BE OBTAINED. ·DISINFECT THE WATER SUPPLY LINE IMMEDIATELY AFTER REPLACING THE WATER FILTER (AT LEAST ONCE A MONTH) EVERY TIME. IN ADDITION, DEPENDING ON THE USAGE ENVIRONMENT, ETC., THE WATER SUPPLY PIPE MAY SINCE THERE IS A RISK OF CONTAMINATION OF THE ROAD WITH VARIOUS BACTERIA, BE SURE TO PERFORM A BACTERIOLOGICAL TEST OF THE RINSE WATER, EVEN IF IT IS DETERMINED THAT DISINFECTION IS NECESSARY FROM THE STANDPOINT OF A SPECIALIST." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE."