EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

IT WAS REPORTED THE XENON LIGHT SOURCE PRESENTED AN OCCASIONAL BLACKOUT. THE ISSUE OCCURRED DURING INSPECTION FOR USE, BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.