EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

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

Additional Manufacturer Narrative

THE DATE OF EVENT IS UNKNOWN. A SUPPLEMENT REPORT WILL BE SUBMITTED IF PROVIDED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION. THE MOST PROBABLE CAUSE OF THE COMPLAINT WAS CAUSE 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.