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Model Number FGS-0636 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This product is not sold in us and is 510(k) exempt.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, the capsule failed to attach.There was no harm to the patient, no intervention was required, and another capsule was used to start the procedure.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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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, the capsule failed to attach.There was no harm to the patient, no intervention was required, and another capsule was used to start the procedure.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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Search Alerts/Recalls
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