WM-NP2 WORKSTATION SET 4 (US)

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Description of Event or Problem

IT WAS REPORTED THAT WHEN WORKSTATION SET 4 IS PLUGGED INTO THE WALL, IT SPARKS AND BEGINS TO SMOKE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO USER ERROR IN THAT THE UNIT WAS REPEATEDLY MOVED WHILE CONNECTED TO THE WALL SUPPLY (CONTRAINDICATED IN THE INSTRUCTIONS FOR USE) WHICH CAUSED THE MAINS LEAD TO BE PULLED FROM THE REAR OF THE TRANSFORMER CAUSING BOTH THE MINOR ARC DAMAGE AND A DISCONNECTION OF THE MAINS SUPPLY FROM THE TRANSFORMER INPUT) AND COMPOUNDED BY A LACK OF MAINTENANCE TO DETECT AND REPLACE THE CABLE/PLUG ASSEMBLY AT AN EARLIER OPPORTUNITY. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.