WM-NP2 WORKSTATION SET 5 - ROW

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED, THE WORKSTATION EXPERIENCED BROKEN RIGHT REAR CASTER. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED EVENT IS LIKELY METAL FATIGUE WHICH OCCURS FOLLOWING THE DEVELOPMENT OF A STRESS CRACK IN THE MOUNTING SPIGOT THAT PROPAGATES THROUGH THE SPIGOT DRIVEN BY THE ADDITIONAL STRESSES NOW BEING PLACED ON THE COMPONENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.