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Model Number FGS-0313 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and 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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Manufacturer Narrative
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Correction: (manufacturer name, first name, last name, street1, city, region, postal code, email), (phone#, fax#).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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