WM-NP2 WORKSTATION SET 4 (US)

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE BROKEN CASTOR ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED TO CAPTURE ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER. THAT INFORMATION IS LOCATED IN B5 & SECTION E. SHOULD FURTHER INFORMATION BE PROVIDED, ANOTHER SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER VIA A PHONE CALL. PER A CALL TO (B)(4), BIOMEDICAL EQUIPMENT TECHNICIAN III, HE STATES THAT THE INCIDENT WITH THE CASTOR WAS INTERESTING AND UNUSUAL. HE SAID THAT THE CASTOR WOULD DRAG AND WAS HARD TO TURN. ALSO, IT WAS WEARING ON THE OUTSIDE AND LEAVING RESIDUE ALONG THE WAY. (B)(4) ORDERED THE CASTOR (AND A SPARE) AND REPLACED IT. THE UNIT IS BACK IN SERVICE AND WORKS FINE. THERE WERE NO ADVERSE EVENTS AND HE STATED IT WAS MORE AN INCONVENIENCE THAN ANYTHING ELSE.

Additional Manufacturer Narrative

THE CUSTOMER CALLED OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) PERSONNEL TO REPORT HIS EVENT. DURING THE CALL, TAC PROVIDED THE CUSTOMER WITH THE REPLACEMENT COMPONENT (NEW WHEEL AND WASHER) NUMBERS IN ORDER TO RESTORE HIS WORKSTATION¿S MOBILITY. AT THIS TIME, THE SUBJECT DEVICE IS NOT SCHEDULED RETURN EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE PRIOR TO THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ONE OF THE WHEELS ON HIS OLYMPUS WM-NP2 WORKSTATION SET 4 HAD BROKEN. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.