EVIS LUCERA ELITE XENON LIGHT SOURCE

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER EXHIBITED NO IMAGE DURING THE MAINTENANCE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.