OLYMPUS

Description of Event or Problem

THE USER FACILITY REPORTED THAT AT THE OUTSET OF A DIAGNOSTIC PROCEDURE, JUST AFTER THE DEVICE WAS INSERTED, THE USERS COULD NO LONGER VISUALIZE THE IMAGE. THE ENDOSCOPE WAS WITHDRAWN FROM THE PT, THE DEVICE RE-TESTED, AND THE IMAGE WAS SAID TO BE BLURRY. THE USERS ELECTED TO ABORT THE PROCEDURE AND THE PT WAS SAID TO BE RE-SCHEDULED FOR ANOTHER TIME. THE USER FACILITY STATED THAT THE PT HAD NOT RECEIVED ANY ANESTHESIA AT THE TIME OF THE EVENT.

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT DUPLICATE THE USER'S REPORT OF A COMPLETE LOSS OF IMAGE. THE IMAGE WAS EXAMINED AND WAS FOUND TO BE WITHIN SPECIFICATION. HOWEVER, THE EVAL ALSO NOTED THE DISTAL END COVER WAS CRACKED, AND THE UNIT FAILED ELECTRICAL LEAKAGE TESTING. ADDITIONALLY, THE BENDING SECTION GLUE AND OBJECTIVE LENS GLUE WERE OBSERVED TO BE CRACKING AND PEELING. THE CRACKED DISTAL END COVER, AND GLUE WERE DETERMINED TO BE DUE TO PHYSICAL DAMAGE. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.