WORKING INSERT, ALBARRAN, TWO WAY

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR INSPECTION. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: DEGRADATION PROBLEM RESULTING IN COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THE CUSTOMER REPORTED THE PIN AT THE DISTAL END WAS MISSING DISPLAYED DURING SET UP INVOLVING AN OLYMPUS WORKING INSERT, ALBARRAN, TWO WAYS. THERE WAS NO PATIENT INJURY REPORTED.