Model Number APC 2 |
Device Problem
Output Problem (3005)
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Patient Problems
Necrosis (1971); Bowel Perforation (2668)
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Event Date 05/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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The apc/esu system was 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.In addition, no anomalies were found in either of the device history record (dhr) of the involved devices.In conclusion, no equipment problems were found that would have caused or contributed to the reported event.Most likely, there were many factors involved in the reported event.However, the patient's condition was a key factor in the outcome.That is, having angiodysplasia in the cecum (a very thin-walled area of the bowel).Specifically, upon argon plasma coagulation (the intervention work), the necrotic tissue (i.E., the assumed treatment area) of the bowl did not stay intact which resulted in the delayed 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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Event Description
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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 a patient incident.A colonoscopy was performed to treat angiodysplasia in the cecum.The system was used with a fiapc® probe 2200 a (part number 20132-221, lot number 128603) and a split return electrode from the 3m company (part number 8180f, lot number 202110mu).The equipment settings were pulsed apc, 20 watts, and flow rate 0.8 liters per minute.Upon argon plasma coagulation, white necrosis of approximate size of 1.5 cm2 was observed in the cecum.The next day a perforation was detected.To address the issue, the intestine was partially resected.
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Search Alerts/Recalls
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