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

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION (H6/H10). BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT WAS USAGE-RELATED WEAR AND TEAR. THE LOOP WIRE AT THE DISTAL END OF THE HF-RESECTION ELECTRODE WEARS OUT DURING USE AND MAY BREAK, BURN OR MELT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR EVALUATION AND THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED, THE LOOP WIRE AT THE DISTAL END OF THE ELECTRODE WAS BROKEN AND IN A MOLTEN SPHERICAL STATE ON ONE END OF THE BROKEN LOOP WIRE. NO OTHER DEFECTS WERE OBSERVED. THE REVIEW OF THE DEVICE HISTORY RECORDS FOR THE AFFECTED LOT OR SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. THE INVESTIGATION IS STILL IN PROGRESS; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Description of Event or Problem

THE CUSTOMER REPORTED, DURING THE TRANS CERVICAL RESECTION IN SALINE PROCEDURE THE LOOP WIRE WAS CUT OFF WHEN OUTPUT WAS PERFORMED TWICE USING THE HIGH FREQUENCY RESECTION ELECTRODE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ELECTRODE FROM THE SAME LOT. THE ELECTROSURGICAL GENERATOR SETTING VALUE WAS AT 120WATTS. AFTER REPLACING THE ELECTRODE, 100WATTS SETTING WAS USED. NO DEATH OR INJURY WAS REPORTED TO OLYMPUS.