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 function 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.However, the patient's condition in all likelihood was a key factor in the outcome.That is, having a malformation 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.The account is being made aware of the findings.To further address the issue, additional in-service work is being offered to the medical staff.No trends have been identified.Erbe usa, inc.Is now closing the file on this event.
|
It was reported that an erbe system, argon plasma coagulator (apc) with an electrosurgical unit (esu/generator, model vio 300 d, part number (p/n) 10140-100, serial number (b)(4)) was involved in a patient incident.The apc/esu settings were pulsed apc, effect 2, 20 watts with a gas flow of 0.5 liters per minute.The system was used with an apc probe to treat a malformation in the right colon.Upon argon plasma coagulation, a perforation occurred.To address the issue, a right hemicolectomy was performed on the patient.
|