Initial medwatch submitted to the fda on 18/may/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 delayed gastric emptying" 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:literature review the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.
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Supplement 01 medwatch submitted to the fda on 20/jun/2023.Additional information: the device has not been returned for analysis, and after multiple attempts to gather more information from the reporter, no additional information has been received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.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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