EVIS LUCERA ELITE XENON LIGHT SOURCE

Additional Manufacturer Narrative

E1 - INITIAL REPORTER ESTABLISHMENT NAME: (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

IT WAS REPORTED THAT THE XENON LIGHT SOURCE HAD BLURRY IMAGE. THE ISSUE WAS FOUND DURING A REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT