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 device labeling notes the following: warnings and precautions: deflated devices should be removed promptly.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, acute pancreatitis, spontaneous inflation, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.If it is necessary to replace a balloon which has spontaneously deflated, the recommended initial fill volume of the replacement balloon is the same as for the first balloon or the most recent volume of the removed balloon.A greater initial fill volume in the replacement balloon may result in severe nausea, vomiting or ulcer formation.Possible complications of the use of the orbera® system include: -balloon deflation and subsequent replacement.
|