EVIS LUCERA ELITE XENON LIGHT SOURCE

Description of Event or Problem

IT WAS REPORTED THAT LIGHT SOURCE HAD SCOPE COMMUNICATION ERROR B30 (SCOPE COMMUNICATION ERROR). THE EVENT OCCURRED DURING INSPECTION FOR USE. 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.