EVIS LUCERA ELITE XENON LIGHT SOURCE

Additional Manufacturer Narrative

E1: (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

THE CUSTOMER REPORTED AN OCCASIONAL BLACKOUT AND WHITEOUT DURING INSPECTION FOR USE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.