MEDICAL CONTROL UNIT FOR ENDOSURGERY

Description of Event or Problem

THE CUSTOMER REPORTED NO IMAGE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS SYSTEM INTEGRATION. THERE WAS NO 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. DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE.