The apc/esu system was returned and thoroughly inspected/tested.A technical safety check was performed on each unit.This included an electrical safety check, a functional check of each of the equipment's features, and a power output check.Also, the gas flow rates were measured and found to be within their acceptable ranges for the apc.All features were/are functioning properly within specifications on both devices.In addition, no anomalies were found in the device history records (dhrs) for the apc and esu.In conclusion, no erbe equipment problem was found that would have caused or attributed to the event.Most likely, there were many factors involved in the reported incident.Specifically, upon the intervention work in a very thin-walled area, the remaining tissue of the bowl did not stay intact (which resulted in the perforation.In conclusion, no determination could be made as to the cause of the event.No trends have been identified.Erbe usa, inc.Is now closing the file on this event.
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It was reported that an erbe system, argon plasma coagulator (apc)/electrosurgical unit (esu/generator, model vio 3, part number (p/n) 10160-000, serial number (b)(4) system was involved in a patient incident to treat an angiodysplasia.While or upon using argon plasma coagulation, a perforation occurred in the cecum.No information was provided on the patient or the medical treatment provided to address the perforation.
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