The reported events were found during a literature review.It was report several patient had the following symptoms - (4 patients) nausea, vomiting, abdominal pain, sore throats, diarrhea and (1 patient) esophageal perforation.The 4 patients were treated conservatively.One patient with the esophageal perforation was treated with a laparoscopic drainage without clinical evidence for perforation.All patients are doing well.
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Combined medwatch submitted to the fda on 27/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 "esophageal perforation, nausea, vomiting, pain (abdominal), and other (sore throat) 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.
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