WM-NP2 WORKSTATION SET 4 (JP)

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY. E1: (B)(6) HOSPITAL.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT THE WM-NP2 WORKSTATION SET 4 (JP) HAD SMOKE COME OUT FROM THE POWER OUTLET. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONALLY, (H4) DEVICE MANUFACTURING DATE WAS ADDED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION PROVIDED, THOUGH THE SPECIFIC ROOT CAUSE COULD NOT BE CONFIRMED, THE REPORTED ISSUE IS CONSISTENT WITH A USE ISSUE WHERE AN INDUCTIVE LOAD WAS CONNECTED/DISCONNECTED FROM THE POWER SUPPLY WHILE THE POWER WAS ON AND PLUGGED IN TO MAINS/AC POWER. WHEN THIS OCCURS, A SURGE CURRENT IS CREATED. THE POWER SUPPLY DISCHARGES THE SURGE ENERGY BY CREATING A VOLTAGE WHICH WILL OVERCOME THE RESISTANCE OF THE AIR AND GENERATE AN ARCING DISCHARGE (SPARK AND/OR SMOKE). THIS IS EXPECTED BEHAVIOR AND IS MITIGATED BY THE SURGE PROTECTION CIRCUIT INCLUDED IN THE POWER SUPPLY DESIGN AND BY THE GUIDANCE PROVIDED IN THE INSTRUCTIONS FOR USE (IFU), INSTALLATION/MANEUVERING/INSPECTION AND MAINTENANCE. HOWEVER, SOMETIMES USERS STILL MOVE WORKSTATIONS WITH THE POWER SUPPLY CONNECTED TO MAINS. IF THE CABLE IS STRETCHED OR PULLED DURING MOVEMENT, THE PLUG MAY BE PARTIALLY OR FULLY REMOVED INADVERTENTLY. EACH OCCURRENCE FURTHER DAMAGES THE POWER SUPPLY MAINS INPUT CONNECTOR. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE IFU: WM-NP2 INSTRUCTION MANUAL SECTIONS: 4.9 EQUIPMENT INSTALLATION, 5.2 MANEUVERING, 6.2 INSPECTION AND 6.4 MAINTENANCE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.