EVIS LUCERA ELITE XENON LIGHT SOURCE

Additional Manufacturer Narrative

DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. 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 EXCESSIVE INSUFFLATION FLOW DURING AN INSPECTION INVOLVING AN OLYMPUS XENON LIGHT SOURCE . THERE WAS NO PATIENT INVOLVEMENT REPORTED.