WM-NP1 110-120V EXERA II CART

Description of Event or Problem

IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, ONE OF THE CASTER WHEELS WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

G4 - PMA/510(K) # EXEMPT CLASS 1 DEVICE THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSE TRACED TO COMPONENT FAILURE. SINCE THE DEVICE IS MORE THAN 15 YEARS OLD, THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.