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Model Number B-50000 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
Vomiting (2144)
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Event Date 01/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the reported event as follows: warnings and precautions: 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.Complications: possible complications of the use of the orbera system include: - gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.- continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.
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Event Description
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Reported as: a patient had the orbera intragastric balloon placed, and after a period, "the patient complained of vomiting and x-ray presented level of air with filling solution in the intragastric balloon." the device was removed.
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Manufacturer Narrative
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Device evaluation summary: the device was returned to apollo for analysis, and visual examination noted the balloon shell to be discolored, as it was dark green in appearance.The center patch was observed to be discolored, as it was yellow in appearance.A sample fill tube was used for device testing.A valve test was performed, and when di water was injected into the valve, the flow of fluid was continuous and unobstructed.An air leak test was performed, and the balloon was noted to be leaking from one opening on the radius of the shell.Under microscopic analysis, the opening measuring approximately 1.1 inches in length, was observed to have striated edges, consistent with damage from a surgical tool.Black particulate matter was observed on the inner surface of the valve channel.
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Search Alerts/Recalls
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