Medwatch sent to the fda on 14/jun/2019.Further information has been requested from the presenter regarding: additional information regarding the reported event, physician information, patient information, and device information.The presentor indicated that they had not seen this patient, and that they would not provide the name of the patient's treating physician.A review of the instructions for use notes the following: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Adverse events: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: hemorrhage, intra-abdominal (hollow or solid) visceral injury.
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