It is unknown if the device is available for return to apollo endosurgery for analysis.Unable to follow up with the reporter as no contact information was provided.Apollo had reached out to local representative who was unable to provide any additional information related to this event or reporter at this time.Device labeling addresses the reported event as follows: warnings and precautions: bowel obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.Some obstructions have reportedly been associated with patients who have diabetes or who have had prior abdominal surgery, so this should be considered in assessing the risk of the procedure.Bowel obstructions can result in death.The risk of intestinal obstruction may be higher in patients who have had prior abdominal or gynecological surgery.The risk of intestinal obstruction may be higher in patients who have a dysmotility disorder or diabetes.The physiological response of the patient to the presence of the orbera® system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Complications: possible complications of the use of the orbera® system include: intestinal obstruction by the balloon.An insufficiently inflated balloon or a leaking balloon that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way through into the colon and be passed with stool.However, if there should be a narrow area in the bowel, as might occur after prior surgery on the bowel or adhesion formation, the balloon may not pass and then may cause a bowel obstruction.If this occurs, percutaneous drainage, surgery or endoscopic removal could be required.Complications of routine endoscopy include: cardiac or respiratory arrest (these are extremely rare and are usually related to severe underlying medical problems).
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Regulatory agency reported via an incident report, "the patient presented with gastric outlet obstruction and at laparotomy was found to have gastric necrosis, requiring a gastrectomy.Patient outcome/consequences: icu admission, gastrectomy, cardiac arrest intra operatively.".
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