EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE LIGHT SOURCE HAD GONE OUT AND COULD NOT BE USED NORMALLY DURING A THERAPEUTIC GASTROINTESTINAL EXAMINATION PROCEDURE INVOLVING AN OLYMPUS XENON LIGHT SOURCE. THE PROCEDURE WAS COMPLETED WITH OLYMPUS BACK UP DEVICE. 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.