Model Number FGS-0313 |
Device Problems
Failure To Adhere Or Bond (1031); Misconnection (1399)
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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, the capsule failed to attach.An endoscopy was done prior to the placement of capsule and the esophagus appeared to be normal.There was nothing unusual about the patient or the procedure and no intervention was required.It was unknown if lube was used to facilitate the capsule replacement.The cause of the failure to attach was also unknown.There was no injury caused to the patient and no repeat procedure was performed.
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Manufacturer Narrative
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Device evaluation: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Evaluation summary: the customer reported the capsule failed to pair with the recorder during calibration.The investigation found the bravo delivery arrived to the investigation site without capsule, therefore, the investigation could not determine a root cause or a probable root cause for the customer's report based on the inadequate sample provided.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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