MOUTHPIECE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSE NOT ESTABLISHED. 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 WHITE, GRANULAR FOREIGN MATERIAL WAS ADHERING TO THE INSIDE OF THE STERILIZED PACKAGE INVOLVING AN OLYMPUS MOUTHPIECE. THERE WAS NO PATIENT INVOLVEMENT.