EVIS LUCERA ELITE XENON LIGHT SOURCE

Additional Manufacturer Narrative

REPORTER STREET ADDRESS LINE 1: (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 HAD NOISED SCREEN. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.