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 FOLLOWING LED TO THE MALFUNCTION: LIGHT SOURCE ENDOSCOPE SOCKET WAS CORRODED CAUSES OCCASIONAL BLACKOUT 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

IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE EXHIBITED OCCASIONAL BLACKOUT. THERE WAS NO PATIENT INVOLVEMENT.