The involved equipment was seized by the judicial authorities and has not, at this time, been made available for inspection/testing.No anomalies were found in the review of the esu's device history record (dhr).If the generator is evaluated and problems are found that could have caused or contributed to the reported incident, a follow-up report will be filed.At this time, no conclusive determination can be made as to the cause of the event.No trends have been identified with this incident.Erbe usa, inc.Is now closing the file on this event.
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It was reported that an incident occurred with the electrosurgical unit (esu/generator) during a cardiovascular surgery (note: an erbe smoke evacuator unit was also being used.It is not a product distributed in the u.S.).No information was provided in regards with the esu's settings or any other involved equipment/accessory.While performing the procedure, a fire occurred.No details were provided as to the origin of the fire.Nevertheless, the flames were quickly extinguished and the surgery continued.Nonetheless, the patient did suffer a burn to the skin.However, the extent and severity of the necrosis was not conveyed to erbe.Additionally, no details were provided in regards to if or how the burn was treated.
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