OLYMPUS

Additional Manufacturer Narrative

THERE HAS BEEN NO DEVICE MALFUNCTION - THIS EVENT IS THE RESULT OF ABNORMAL USE - THIS REPORT IS SUBMITTED IN AN ABUNDANCE OF CAUTION. THE WM-260 MOBILE WORKSTATION IS A DISCONTINUED PRODUCT, WAS LAST MANUFACTURED IN 2005. NO EVENT CODES HAVE BEEN ENTERED IN THE REPORT AS THERE WAS NO PATIENT INVOLVEMENT, NO DEVICE MALFUNCTION AND THE DEVICE IS NOT REQUIRED TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

OLYMPUS MOBILE WORKSTATIONS ARE INTENDED FOR USE IN MEDICAL FACILITIES UNDER THE DIRECTION OF A TRAINED PHYSICIAN AND ARE DESIGNED TO BE USED WITH A RANGE OF OLYMPUS EQUIPMENT TO FACILITATE GI ENDOSCOPY, ENDOSCOPIC ULTRASOUND, RESPIRATORY AND SURGICAL ENDOSCOPIC PROCEDURES. KEYMED ( MEDICAL & INDUSTRIAL EQUIPMENT) LTD HAS BEEN MADE AWARE OF AN EVENT WHEREBY TWO NURSES WERE PUSHING A WORKSTATION EACH, THROUGH THE CORRIDORS OF THE HOSPITAL (FLAT LINOLEUM SURFACE). THE FIRST NURSE (PUSHING THE WM-NP1 MOBILE WORKSTATION ) PAUSED OR HESITATED AND THE SECOND NURSE (PUSHING THE WM-260 WORKSTATION) WAS TOO NEAR TO THE FIRST NURSE. THE SECOND NURSE DIDN'T REACT IN TIME AND PUSHED THE WM-260 WORKSTATION INTO THE FIRST NURSE. THE FIRST NURSE ATTENDED THE ACCIDENT & EMERGENCY DEPARTMENT AT THE HOSPITAL AND REQUIRED STITCHES IN THE BACK OF HER FOOT.