WM-DP2 WORKSTATION SET 1 - UK

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: SCORCHING ON BASE AND MELTED PLASTIC. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: SCORCHING ON BASE CAUSED BY A POWER CABLE SITTING ON THE BASE NOT PLUGGED IN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A LARGE SPARK FROM THE UNDERNEATH SECTION OF THE ENDOSCOPY WORKSTATIONS WHERE ALL THE CABLES WERE HOUSED AND SOME SCORCHING. THE ISSUE WAS FOUND DURING SEDATION - DEVICE INSIDE PATIENT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE AND IT WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.