HF UNIT "ESG-400"

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3003724334.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS. DURING THEIR INSPECTION, THE SBC FOUND THAT THE HAND SWITCH FUNCTION AT THE MONOPOLAR 1 OUTPUT WAS NOT WORKING. THE SBC TRACED THIS ISSUE BACK TO A DEFECTIVE MOTHERBOARD. FINALLY, THE SBC FOUND THE CONTACTS OF THE MONOPOLAR 1 CONNECTION SOCKET OF THE FRONT PANEL TO BE CORRODED. THE SBC DID NOT DETAIL IF THERE WAS AN ELECTRICAL OR FUNCTIONAL IMPAIRMENT. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. ERROR E433 IS TRIGGERED BY THE DEVICE¿S SAFETY SYSTEM AND OCCURS IF THE EFFECTIVE VALUE OF THE OUTPUT SIGNAL WHICH IS SET FOR TESTING FALLS BELOW THE INTENDED LIMIT OF 130V. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

Description of Event or Problem

IT WAS REPORTED TO OLYMPUS THAT A GENERATOR (HF UNIT) HAD AN E433 ERROR. THE PATIENT WAS NOT UNDER SEDATION AND THERE WAS NO DELAY. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.