WM-NP2 WORKSTATION SET 4 (US)

Additional Manufacturer Narrative

SEE UPDATE IN G2 ¿ HEALTH PROFESSIONAL.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE THE UPDATES IN SECTIONS H4, H6, AND H10. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THE DEVICE WAS NOT RETURNED; THEREFORE, THE REPORTED PHENOMENON OR CONDITION OF THE DEVICE COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE REVIEWED FOR THIS DEVICE HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SPECIFIC ROOT CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED AT THIS TIME BECAUSE THE DEVICE WAS NOT RETURNED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT THE CART CASTER WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.