WM-NP2 WORKSTATION SET 3 (ROW)

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION AND CORRECTIONS. UPDATED FIELDS: B5, D8, H2, H3, H4, H6 AND H11. CORRECTED FIELDS: A2, A4, A6, A5, B5, B6, B7 AND H6. THE DEVICE WAS INSPECTED FOR ONSITE REPAIR, AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED MALFUNCTION REAR LEFT WHEEL SNAPPED OFF TROLLEY COULD NOT BE 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

THERE WERE NO REPORTS OF PATIENT HARM. NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THE WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS HAD REAR LEFT WHEEL SNAPPED OFF TROLLEY. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.