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: DUE TO FRONT PANEL WAS CRACKED AT THE INTERFACE, HAS LIQUID IMMERSION. 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 WATER INVASION IN FRONT PANEL FROM CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.