Model Number APC 3 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Bowel Perforation (2668)
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Event Date 10/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 incident.However, based upon the provided documentation there are two possible scenarios: 1.The use of the different mode (including other non-typical settings employed) resulted in excessive coagulation and the perforation (as concluded by the user).2.During the intervention work in the cecum (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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Event Description
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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 during a colonoscopy.No information was provided in regards to other equipment or accessories involved in the procedure.However, it was stated that the forcedapc mode was inadvertently used instead of the pulsedapc mode that is in their "cecum program".Nevertheless, while coagulating with argon plasma in the cecum, a perforation occurred.No details were conveyed to erbe in regards with the patient's condition (including additional medical treatment, hospitalization, etc.To address the perforation).
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Search Alerts/Recalls
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