EVIS LUCERA ELITE XENON LIGHT SOURCE

Additional Manufacturer Narrative

E1- FACILITY ADDRESS - (B)(6). 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 XENON LIGHT SOURCE EXHIBITS NOISY SCREEN AND THE IMAGE TURNED PURPLE DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.