OLYMPUS

Additional Manufacturer Narrative

DEVICE WAS MANUFACTURED IN 2006. OLYMPUS (B)(4) PLAN TO RETURN THE SUBJECT DEVICE TO THE MANUFACTURER - KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD FOR INVESTIGATION. KEYMED HAVE REQUESTED A COPY OF THE MAINTENANCE RECORDS FROM THE HEALTHCARE FACILITY AND ANY SERVICE EVENTS AT THE OLYMPUS REPAIR CENTRE. DEVICE AWAITING RETURN OF DEVICE.

Description of Event or Problem

THE OLYMPUS WM-NP1 SERIES MOBILE WORKSTATION IS INTENDED FOR USE IN MEDICAL FACILITIES UNDER THE DIRECTION OF A TRAINED PHYSICIAN AND HAS BEEN DESIGNED TO BE USED WITH A RANGE OF OLYMPUS EQUIPMENT TO FACILITATE GI ENDOSCOPY, ENDOSCOPY ULTRASOUND, RESPIRATORY AND SURGICAL ENDOSCOPIC PROCEDURES. KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD HAS BEEN MADE AWARE OF AN EVENT WHICH TOOK PLACE IN (B)(6). THE THREADED STUD OF THE RIGHT REAR CASTOR OF THE WORKSTATION BROKE WHEN THE WORKSTATION WAS MANOEUVRED. THE WORKSTATION WAS CAUGHT BY HEALTHCARE FACILITY STAFF. THERE IS NO REPORT OF INJURY TO PATIENT OR USERS AND THIS REPORT IS SUBMITTED IN AN ABUNDANCE OF CAUTION.

Additional Manufacturer Narrative

INVESTIGATION BASED ON THE RETURN OF THE WORKSTATION CASTOR TO THE MANUFACTURER. THE WORKSTATION WAS MANUFACTURED IN 2006. THE MOST PROBABLE CAUSE IDENTIFIED BY THE INVESTIGATING ENGINEER WAS THAT THE CASTOR WASHER INSIDE DIAMETER WAS NOT SUFFICIENT TO ACCOMODATE THE CASTOR STEM. THE INSIDE DIAMETER OF THE WASHER WAS INCREASED BY 0.3MM FOLLOWING A DESIGN REVIEW IN 2007