WM-NP2 WORKSTATION SET 3 (EU)

Description of Event or Problem

THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTIONS. CORRECTED FIELDS: E1, A2, A4, A5, A6, B5, B6, B7, AND H6. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED MALFUNCTION WAS TRACED TO BE A 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

IT WAS REPORTED THAT THE WM P2 SERIES OF ENDOSCOPY WORKSTATIONS HAD A BROKEN WHEEL. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.