WM-NP2 WORKSTATION SET 4 (US)

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY SPECIFIED. PARTS AND PHOTOGRAPHS WERE UNAVAILABLE TO CONDUCT A MEANINGFUL INVESTIGATION. COMPONENT FAILURE OF THE NATURE DESCRIBED BY THE COMPLAINANT TYPICALLY REQUIRES MULTIPLE INPUTS, OCCURRING COINCIDENTALLY PRIOR TO PRESENTING THEMSELVES AS A SINGLE, CATASTROPHIC EVENT. AS THE FAILED COMPONENT PARTS WERE UNAVAILABLE FOR DETAILED INVESTIGATION, CONCLUSIONS COULD NOT BE DRAWN WITH HONESTY AND INTEGRITY. THE PROVIDED INFORMATION INDICATED THIS PARTICULAR PRODUCT WAS OPERATING OUTSIDE OF THE DESIGNED WORKING LIFE SPAN.

Additional Manufacturer Narrative

IN TROUBLESHOOTING THE ISSUE WITH OLYMPUS TECHNICAL SUPPORT VIA THE PHONE, THE CUSTOMER REQUESTED TO PURCHASE A REPLACEMENT CASTER TO REMOVE AND REPLACE THE DAMAGED CASTER. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

THE USER FACILITY REPORTED TO OLYMPUS THAT THE BOLT THAT SECURES THE CASTER ON THE WM-NP2 WORKSTATION SET HAD BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED.