WM-NP2 WORKSTATION SET 4 (JP)

Description of Event or Problem

IT WAS REPORTED THAT THE WORKSTATION EXHIBITED DAMAGE TO THE CASTOR. THE ISSUE OCCURRED DURING SET UP AND INSPECTION BEFORE PATIENT IN ROOM. THERE WAS NO REPORT OF PATIENT HARM.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. THE DEVICE WAS RETURNED FOR INSPECTION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION IT IS LIKELY THAT THE EVENT REPORTED 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. THIS REPORT WAS SENT IN ERROR AS THE CASTER IS BROKEN WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR.