WM-NP2 WORKSTATION SET 5 (EU)

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO CUSTOMER MISUSE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE WHEEL OF THE WORKSTATION TROLLEY WAS PUSHED OVER A DOORSTEP AT HIGH SPEED RESULTING IN ONE OF THE WHEELS BREAKING OFF. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO A 3RD PARTY DISTRIBUTOR AND WAS REPAIRED ONSITE AT A LOCAL SERVICE CENTER. THE FAILURE OCCURRED USING A NON-BRAKED CASTOR WHICH WAS FITTED TO THE BACK RIGHT OF THE WORKSTATION. IN ADDITION, A GAS CYLINDER HAD BEEN FITTED TO THE WORKSTATION. ALL OF THE WHEELS WERE REPLACED ON THE TROLLEY. THE WORKSTATION DID NOT HAVE AN OLYMPUS SERVICE HISTORY, WITH NO PREVIOUS CASTOR ISSUES ON THE WORKSTATION OR WITHIN THE FACILITY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.