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Model Number FGS-0312 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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, a bravo capsule failed to attach during the procedure.There was no harm to the patient or user and a repeat procedure was necessary due to the alleged device malfunction.The equipment and capsule is expected to be returned for evaluation.
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Manufacturer Narrative
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Device evaluation: one bravo ph capsule delivery device and one capsule were received for investigation.The capsule was not attached to the delivery device.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.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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