It is reported in the literature article "short-term outcomes of double versus single pyloromyotomy at peroral endoscopic pyloromyotomy in the treatment of gastroparesis" appearing in volume 92, no.3: 2020 of the gastrointestinal endoscopy journal, that a patient experienced a procedure related adverse event following a single pyloromyotomy using a gastroscope, transparent distal cap attachment, insufflation device, and either a hybrid knife i-type (erbe-germany) or a hookknife.This patient experienced the adverse event of tension capnoperitoneum.The patient was treated with needle decompression and recovered without any consequences.
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This report is being submitted to report investigation results.A review of the device history record (dhr) could not be conducted, as no serial number was provided.Olympus conducts comprehensice quality inspections on all devices prior to shipment, and doe not ship any device that does not meet specifications.No containement measures are warranted.At this time there is no information to suggest that the reported event may expand.Conclusion: no device malfunction was reported.The definitive cause of the event is not established.
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