EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Description of Event or Problem

The customer reported image noise during Inspection for use involving an Olympus Gastrointestinal Videoscope. There was no patient injury reported.

Additional Manufacturer Narrative

E1 - 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.