WM-NP2 WORKSTATION SET 4 (US)

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND UPDATES TO D8, H3, H4 AND H6. ADDITIONALLY, A CORRECTION TO D4 (UNIQUE IDENTIFIER (UDI) NUMBER) WAS MADE - THE UDI WAS ADDED AS IT WAS INADVERTENTLY OMITTED IN THE INITIAL REPORT. SINCE THE DEVICE IS MORE THAN 13 YEARS OLD, THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, ROOT CAUSE OF THE REPORTED ISSUE IS LIKELY A USER ERROR WHERE THE POWER PLUG IS NOT BEING UNPLUGGED FROM THE WALL POWER OUTLET PRIOR TO MOVING THE WORKSTATION. BEING REPEATEDLY MOVED WHILE STILL CONNECTED TO THE WALL POWER OUTLET (CONTRAINDICATED IN THE INSTRUCTIONS FOR USE) CAUSES THE POWER PLUG TO BE PULLED FROM THE WALL SOCKET, ARC DAMAGE, AND A DISCONNECTION OF THE POWER FROM THE TRANSFORMER INPUT OF THE WORKSTATION, COMPOUNDED BY A LACK OF MAINTENANCE TO DETECT AND REPLACE THE CABLE/PLUG ASSEMBLY AT AN EARLIER OPPORTUNITY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED, THE ENDOSCOPY WORKSTATION'S CART HAD BURN MARKS AND LEFT A BURN MARK ON THE OUTLET. THE ISSUE WAS FOUND AFTER SUCCESSFULLY COMPLETING A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM OR PROCEDURAL DELAY.