HF UNIT "ESG-400"

Description of Event or Problem

IT WAS REPORTED TO OLYMPUS THAT A GENERATOR (HF UNIT) HAD E002 E006 ERRORS AND WAS SENT IN FOR REPAIR. THE REPORTED ISSUE WAS DURING REPROCESSING OF THE DEVICE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTIONS TO B3, B5, G2 (ALSO SELECTED ¿OTHER¿) WHICH WERE INADVERTENTLY LEFT OFF THE INITIAL REPORT. THE CUSTOMER'S REPORTABLE MALFUNCTION WAS NOT CONFIRMED. 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 FOR THE REPORTABLE PHENOMENON, IT IS LIKELY THAT ERROR MESSAGE E006 WAS TRIGGERED BY A USER ERROR OR A DEFECTIVE INSTRUMENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THIS EVENT OCCURRED DURING A TRANSURETHRAL PROCEDURE, WHICH WAS COMPLETED. THE DEVICE WAS INSPECTED BEFORE USE.

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 (B)(4).