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

THE CUSTOMER REPORTED LINES ON THE SCREEN DURING INSPECTION FOR USE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.