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Model Number FGS-0313 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2020 |
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 the user.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 lubrication was used to facilitate placement of the capsule, and the delivery system and capsule will be returned for investigation.
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Search Alerts/Recalls
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