EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

THE CUSTOMER REPORTED A BLACK SCREEN DURING REPROCESSING INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT 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.