MEDICAL CONTROL UNIT FOR ENDOSURGERY

Additional Manufacturer Narrative

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 NO IMAGE DISPLAYED BETWEEN THE INTEGRATION SYSTEM AND ROOM CAMERA HIGH-DEFINITION MULTIMEDIA INTERFACE PORT OF THE SURGICAL MICROSCOPE, WHICH DID NOT POPULATE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS SYSTEM INTEGRATION. THERE WAS NO PATIENT INJURY REPORTED.