WM-NP2 WORKSTATION SET 4 (JP)

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED 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, THE MOST LIKELY ROOT CAUSE IS 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). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED A SHORT CIRCUIT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.