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Model Number FGS-0313 |
Device Problems
Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Consequences Or Impact To Patient (2199); Not Applicable (3189)
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Event Date 05/30/2019 |
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.It was in the wrong passage when it was rechecked, but the capsule was removed afterwards.There was no harm to the patient or user, 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.A lubricant was used to facilitate placement of the capsule.Another capsule was used to resolve the issue.
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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.It was in the wrong passage when it was rechecked, but the capsule was removed afterwards.There was no harm to the patient or user, 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.A lubricant was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.Another capsule was used to resolve the issue.
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Search Alerts/Recalls
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