WM-NP3 MOBILE WORKSTATION ROW GI

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION IS BEING MADE TO PREVIOUSLY SUBMITTED E1 - INITIAL REPORTER ADDRESS, WHICH WAS NOT LATE. THE CORRECT INITIAL REPORTER WAS INTERNAL TO OLYMPUS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER THREE (3) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT/REPORTABLE MALFUNCTION WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO ITEM WAS AVAILABLE FOR RETURN FOR A COMPLETE AND MEANINGFUL INVESTIGATION. LIKEWISE, NO IMAGE OF THE CASTOR COULD BE PROVIDED. HOWEVER, FROM THE NARRATIVE PROVIDED, OLYMPUS PRESUMES THE MOST LIKELY CAUSE OF THIS PARTICULAR FAILURE IS METAL FATIGUE, PROVOKED BY MULTIPLE IMPACTS. THIS OCCURS FOLLOWING THE DEVELOPMENT OF A STRESS CRACK IN THE MOUNTING SPIGOT, DUE TO AN UNKNOWN ORIGIN, THAT PROPAGATES THROUGH THE SPIGOT DRIVEN BY THE ADDITIONAL STRESSES NOW BEING PLACED ON THE COMPONENT. THIS PROPAGATION EVENTUALLY CAUSES A LOSS OF PRE-TENSION IN THE THREADED JOINT AND THE CASTOR WORKS LOOSE. THIS CONTINUED LOOSENING EXPEDITES THE RATE OF CRACKING UNTIL THE EFFECTIVE CROSS-SECTIONAL AREA OF THE CASTOR MOUNTING SPIGOT IS REDUCED TO SUCH AN EXTENT, THAT INEVITABLY, A COMPLETE BRITTLE FRACTURE OF THE CASTOR SPIGOT OCCURS, OFTEN WITHOUT WARNING AND WITH A SEEMINGLY INNOCUOUS LOAD BEING APPLIED. THERE ARE SEVERAL POTENTIAL KNOWN CAUSES OF THE CRACK ORIGIN BUT NON-AVAILABILITY OF EITHER PART OF THE BROKEN CASTOR SPIGOT PREVENTS FURTHER INVESTIGATION.

Description of Event or Problem

THE ISSUE OCCURRED WITH THE FRONT RIGHT BRAKED CASTOR. THE FAILURE WAS FOUND DURING INSPECTION IN LOANER CENTER WHEN IT WAS RETURNED FROM THE CUSTOMER.

Description of Event or Problem

IT WAS REPORTED THE MOBILE WORKSTATION HAD A BROKEN CASTOR. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.