WM-NP2 WORKSTATION SET 4 (JP)

Description of Event or Problem

IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CASTER OF ENDOSCOPY WORKSTATIONS WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

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: THIS EVENT IS CAUSED BY A COMPONENT FAILURE OF THE CASTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.