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Model Number B-50000 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problems
Pain (1994); Vomiting (2144)
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Event Date 09/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Medwatch sent to the fda on 11/15/2016.The reporter of the event was asked to return the product for analysis.The device has not yet been received by apollo.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 symptoms.Possible complications: possible complications of the use of orbera 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.Abdominal or back pain, either steady or cyclic.
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Event Description
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Reported as: a patient had the orbera intragastric balloon placed, and after a period "patient complaint of new symptoms, progressive and intense, like pain in the epigastric region, constant distension and appetite loss.Patient evolved with inability to feed, uncontrollable vomiting and painful distention visible on physical examination.It was required abdomen x-ray that showed hyperinflation of the balloon, requiring the exchange of the same, to preserve the health and life of the patient." the device was removed and replaced.
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Manufacturer Narrative
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Supplement #1 - medwatch sent to the fda on 02/21/2017.Additional information: device available for evaluation?, device evaluated by mfr?, evaluation codes, additional mfr narrative.Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.A visual examination noted blue discoloration on the shell.Yellow particles were observed on the outer surface of the shell, patch and valve.A valve test was performed and flow of fluid was continuous and unobstructed.An air leak test was performed and leakage was observed.Under microscopic analysis noted thirteen small striated openings and one large striated opening, 5 mm in length, all consistent with device removal.Yellow and brown particles were observed in the valve channel.
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Search Alerts/Recalls
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