WM-NP2 WORKSTATION SET 4 (JP)

Description of Event or Problem

IT WAS REPORTED THE ENDOSCOPY WORKSTATION CASTOR HAD BROKEN OFF. IT IS UNSPECIFIED WHEN THIS ISSUE OCCURRED. 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.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS BELIEVED THAT THE LIKELY CAUSE OF THE BROKEN CASTER WAS METAL FATIQUE. IT WAS REPORTED THAT THERE WAS A STRESS CRACK IN THE MOUNTING SPEGOT WHICH EVENTUALLY CAUSED A LOSS OF PRE TENTION IN THE THREADED JOINT LOOSENING THE CASTER. THE LOOSENING EXPEDITED THE RATE OF CRACKING UNTIL A COMPLETE BRITTLE FRACTURE OF THE CASTOR SPIGOT OCCURED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.