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Model Number FGS-0313 |
Device Problems
Loss of or Failure to Bond (1068); Appropriate Term/Code Not Available (3191)
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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, roth net was used to successfully retrieve the capsule from the stomach, and a repeat procedure was performed.The patient was coughing and restless during sedation and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.The delivery system and capsule will not 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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Search Alerts/Recalls
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