EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

THE CUSTOMER REPORTED A BLACKOUT DURING A DIAGNOSTIC PROCEDURE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, AND THE EVENT OCCURRED DURING SEDATION WHILE THE DEVICE WAS INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

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