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Model Number FGS-0635 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, they had a capsule which failed to detach from the delivery system.There was no harm to the patient and no intervention was required.There was nothing unusual about the patient or the procedure, and an endoscopy had been performed prior to the procedure that showed the esophagus to be normal.The plunger did not pop back up during the procedure, and the physician broke the handle on the delivery device so that the capsule can be placed on the patient's esophagus.
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Search Alerts/Recalls
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