EVIS LUCERA ELITE XENON LIGHT SOURCE

Additional Manufacturer Narrative

E1 - INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). E1 - ADDRESS 1: (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 SCREEN BLACKOUT DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.