EVIS LUCERA ELITE XENON LIGHT SOURCE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE MOST PROBABLE CAUSE OF THE MALFUNCTION IS TRACED TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THE CUSTOMER RETURNED THE XENON LIGHT SOURCE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE INTERFACE HAD TRACES OF LIQUID IMMERSION AND THE INTERIOR WAS RUSTY AND NOT GOOD. THERE WAS NO PATIENT INVOLVEMENT.