Model Number NOT APPLICABLE |
Device Problems
Material Separation (1562); Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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There have been a significant number of tube replacements or removals and this is the first such event to be reported.Material separation has been anticipated in the a-tube risk assessment and mitigated as far as possible by design and testing of the a-tube, and assessment of the risks associated with removal of separated pieces of the a-tube by endoscopic means.What has been learned as a result of this event is that placement of the snare may be important particularly in older implants.As a result the instructions for a-tube removal are being revised to specify placement of the snare as an additional means of risk reduction.The clinicians are now reminded not to attach the snare at the aspiration holes but rather at the full circumference of the a-tube for more secure purchase during removal.
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Event Description
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During the procedure where the a-tube was removed, the a-tube split into 2 sections in esophagus.After removal of the small piece the gastroscope was used again to remove the second part.No problems reported for the patient.After the a-tube was removed the endoscope was reinserted to evaluate the stomach and esophagus which revealed minimal damage to the mucous membranes consistent with tube removal.
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Search Alerts/Recalls
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