Combined medwatch submitted to the fda on 23/jun/2023.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "pain (abdominal); ulcer; pancreatitis; vessel damage / bleeding; migration and cholangitis" as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.Possible complications that may result from using the endoscopic suturing system include, but may not be limited to: pharyngitis / sore throat, nausea and / or vomiting, abdominal pain and / or bloating, hemorrhage, hematoma, conversion to laparoscopic or open procedure, stricture, infection / sepsis, pharyngeal, colonic and/or esophageal perforation, esophageal, colonic and/or pharyngeal laceration, intra-abdominal (hollow or solid) visceral injury, aspiration, wound dehiscence, acute inflammatory tissue reaction & death, note: any serious incident that has occurred in relation to the device should be reported to apollo endosurgery and any appropriate government entity.Additional information: the device has not been returned for analysis and attempts to gather more information from the reporter is not visible as this is a literature review, and the author does not have the information for the device.The investigator determined a device history record (dhr) review is not possible.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.
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This report was discovered during a literature review where it was discussing the adverse event of ercp (edge) procedures.The following events were mentioned as adverse event - ucler, pancreatitis, bleeding, pain, migration and cholangitis.It was not discussed how many patients were for each event it was just listed.These event may have already been reported but unable to verify as we do not have the information about each event.This literature review covers from 2015 to 2021.
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