OLYMPUS EVIS EXERA COLONOVIDEOSCOPE

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THE COLONOSCOPE WAS WITHDRAWN FROM THE PT AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT BUT SIMILAR ENDOSCOPE. THERE WAS NO PT INJURY REPORTED.

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT CONFIRM THE USER'S REPORT OF IMAGE LOSS; HOWEVER, THERE WAS EVIDENCE OF FLUID INVASION IN THE ELECTRICAL CONNECTOR, SCOPE CONNECTOR, AND CONTROL BODY UNIT, WHICH LIKELY CAUSED THE IMAGE DIFFICULTY. THE DEVICE PASSED THE LEAK TEST. THE BENDING SECTION COVER AND BENDING SECTION COVER GLUE ARE FOUND TO BE A NON-OLYMPUS REPAIRS. THE OBJECTIVE LENS WAS CRACKED. THE SWITCH #1 BUTTON IS NOT WORKING. THE INSERTION TUBE FAILED THE INSULATION TEST. THE DEVICE WAS REFURBISHED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN EXCESS OF CAUTION.