The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.A review of the instructions for use notes the following: warning: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Ensure that there is sufficient space for the needle to open.Warning: do not introduce the device with the needle body in its open position.Adverse event: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: abdominal pain and / or bloating.Pharyngeal, colonic and/or esophageal perforation.Esophageal, colonic and/or pharyngeal laceration.Intra-abdominal (hollow or solid) visceral injury.
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Reported as: a patient who underwent an endoscopic sleeve gastroplasty (esg) utilizing the overstitch endoscopic suturing system was noted to have a perforation and leak.The patient was transferred to a hospital where the patient was drained, washed out and complete esg was taken down.Additional information provided by the physician,"five sutures went smoothly.The next day the patient experienced pain and requested analgesia.An ed evaluation and ct noted air + acute abdomen.There was a 5-7mm perforation mid-body thought maybe to be a needle anchor pulled through under tension.Drains placed with no drainage since.It was noted the patient developed dyspnea and the ct noted the patient had a pulmonary embolism which spontaneously dislodged during the catheter study.The patient is doing well.".
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