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 "bleeding and ulcer" as follows: the apollo endosurgery overstitch¿ endoscopic suture system (ess) is intended for endoscopic placement of suture(s) and approximation of soft tissue.Warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Contact of electrosurgical components with other components may result in injury to the patient and/or operator as well as damage to the device and/or endoscope.Verify compatibility of endoscopic instruments and accessories and ensure performance is not compromised.Note: refurbished scopes may no longer confirm to original specifications.Adverse events 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.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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