EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE HAD NOISY IMAGES. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, RUST ON THE INTERFACE IS CONSIDERED THE MOST LIKELY CONTRIBUTOR TO THE OBSERVED IMAGE NOISE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.