HF-RESECTIONELECTRODE"PLASMALOOP¿MEDIUM,30°",LOOP,24FR,STANDARD,12°-30°,FORTCRIS

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.

Description of Event or Problem

IT WAS REPORTED TO OLYMPUS THAT A HF-RESECTIONELECTRODE WAS DISTORTED AND THAT THERE WAS A CATCH WHEN PASSING THE SHEATH. AT THE TIME OF INSPECTION BEFORE USE. IT WAS CONFIRMED AND REPLACED WITH ANOTHER ONE, AND THE PLANNED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.