WM-NP2 WORKSTATION SET 1 (ROW)

Description of Event or Problem

NO OTHER UPDATED INFORMATION FROM THE CUSTOMER.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D4 (UNIQUE DEVICE IDENTIFIER (UDI) #1), D8, D9, G4 (PMA/510(K) #), H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE OF CASTOR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

E1 FACILITY NAME: (B)(6) HOSPITAL. E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. 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 THAT THE SUBJECT DEVICE HAD WHEELS FRACTURED. THE ISSUE WAS IDENTIFIED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.