The apc/esu system was returned and thoroughly inspected/tested.An electrical safety test was performed on each unit and no issues were found with the equipment.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.However, in each case, the patient's condition in all likelihood was a key factor in the outcome.That is, having to perform argon plasma coagulation in the right colon, a very thin-walled area of the bowel.Specifically, upon the intervention, 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) with an electrosurgical unit (esu/generator, model vio 200 d, part number (p/n) 10140-200, serial number (b)(4)) was involved in two (2) patient incidents.The settings were forced apc, 40 watts.A colonoscopy was performed on each of the patients and argon plasma coagulation was used in the right colon in their treatment.Both patients had a delay perforation (i.E., a perforation was detected approximately a day or more after their colonoscopy.).With one (1) of the patients, a colectomy was performed to address the issue.No further information was provided regarding the patients.Note: system distributed to a hospital in the (b)(6).
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