UNKNOWN

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURE'S (LM) FINAL INVESTIGATION. BASED ON THE RESULTS OF THE RELATED COMPLAINT INVESTIGATION, THERE WERE NO OBVIOUS DEVIATIONS FROM THE INSTRUCTION FOR USE (IFU) REGARDING REPROCESSING PROCEDURES. SINCE NO DEVICES WERE RETURNED, OLYMPUS WAS UNABLE TO DETERMINE A RELATIONSHIP BETWEEN THE DEVICES AND THE POSITIVE CULTURE RESULTS. THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST: SAMPLING DATE: UNKNOWN MICROBIOLOGICAL TEST RESULTS, INCLUDING DEVICE CULTURE TESTS: MICROORGANISM NAME: ACID-FAST BACTERIA BACTERIAL QUANTITY: UNKNOWN. THE REPORTED EVENT WAS NOT CONFIRMED AS THE SCOPE WAS NOT MICROBIOLOGICALLY TESTED BY OLYMPUS. AS THE MODEL NUMBER AND SERIAL NUMBER ARE UNKNOWN, OLYMPUS COULD NOT CONFIRM THE MANUFACTURING HISTORY OR REVIEW THE DEVICE HISTORY REPORT (DHR). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

NO DEVICE INFORMATION WAS PROVIDED BY THE CUSTOMER. FOLLOW UP FOR DEVICE MODEL NUMBER, SERIAL NUMBER, AND HOW MANY TIMES THE SCOPE WAS USED AFTER REPROCESSING WAS COMPLETED; HOWEVER, NO ADDITIONAL INFORMATION WAS AVAILABLE. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT ACCUMULATED WATER WAS SAMPLED AND CULTURED, RESULTING IN THE DETECTION OF ACID-FAST BACTERIA. THE ISSUE WAS FOUND DURING THE LEAK DETECTION PROCESS WHICH WAS CARRIED OUT WITHOUT INSTALLING A SCOPE ON THE WASHER. THE ENDOSCOPE¿S PRODUCT NUMBER, SERIAL NUMBER, AND NUMBER OF CASES USED COULD NOT BE IDENTIFIED AND ARE UNKNOWN. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.