It was reported that "during surgery an arc jumped from the insulative sheath of the es active accessory electrode to the pt and caused a minor burn. " it was also stated that "the surgeon had used a short length of "red robin" catheter tubing as an extension to the insulative sheath of the electrode. The arc occurred at the junction point of the catheter tubing and the insulative sheath on the electrode. ".

The production records for this device were reviewed and found to be complete and in order. The device appears to have been made to specification. The device was not returned to conmed for testing or eval but it was sterilized and examined by the biomedical engineering dept of the hosp. They reported that the device showed no signs of failure or malfunction. They feel the arc was caused by the electrical current that was transmitted by the column of fluid that was trapped under the "red robin" catheter tubing that was slipped over the electrode. The current exited through the gap between the catheter and the insulative hub/shath of the electrode. They have since instructed all surgeons/sugical teams that they are not to modify or alter the es active electrodes with catheters or by any other means. The burn was minor and needed no follow-up treatment or care. Co feels that this investigation is closed.