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 BLACKOUT DURING A DIAGNOSTIC PROCEDURE, INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED