This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additionally, the following fields were updated: d9, h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.The device was returned to olympus for inspection, and there were no malfunctions identified.The legal manufacturer reviewed images provided by the customer which showed the non-split neutral electrode type used during the procedure, and the patient burn where the neutral electrode had been.Where the electrode had been was not completely free of hair (on an unshaven chest).Based on the results of the investigation, it is likely the reported issue occurred due to a user error.The occurrence of burns in the area of the neutral electrode can occur from monopolar applications.In most cases, these burns are caused by the following: - an incorrectly affixed electrode.- improper preparation of the respective skin area (remaining hair).- residues of disinfectant are located between skin and neutral electrode.- mechanical pressure is exerted on a certain point of the affixed neutral electrode during activation.Such user errors will result in an increased current density which may have a thermal effect on the adjacent skin and lead to burns.Olympus will continue to monitor field performance for this device.
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