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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 will be returned for investigation.
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Manufacturer Narrative
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Additional information: evaluation summary one bravo ph capsule delivery device was received for investigation.The capsule was not returned.Visual inspection did not reveal any damage and appears to have functioned within specification.Functional testing could not be performed because this is a single use device and once the capsule is delivered it cannot be functionally tested.Investigation conclusion for the failure to attach could not be reliably determined.A review of the device history record was performed and indicates that the product was released meeting finished product specifications.We were unable to confirm the customer¿s report.Corrected information: (device evaluation), h6(evaluation code - method, evaluation code- result, evaluation-conclusion).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Corrected information: if information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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