EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE XENON LIGHT SOURCE EXHIBITED A NOISY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION IT IS CAUSE TRACED TO COMPONENT FAILURE DUE TO METAL CONTACTS AT THE INTERFACE WERE BROKEN, REBOUND OF THE PROTECTIVE PLATE WAS NOT GOOD, AND INTERFACE WAS WORN AND NOT GOOD SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.