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Model Number FGS-0635 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2020 |
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 attach.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.No lubricant was used to facilitate placement of the capsule.
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Search Alerts/Recalls
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