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Model Number FGS-0313 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 procedure, but the patient was consistently coughing.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.
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Manufacturer Narrative
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This report is based on information provided by medtronic investigation personnel and the sample that arrived.1 bravo capsule and 1 bravo delivery device were received for evaluation.A review of the product expiration date discovered this product was used before the expiration date.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported bravo fail to attach to patient's esophagus.The reported condition was not confirmed.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found the device to function normally and within specifications.No corrective action is required, because no failure mode was identified.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.No intervention was required, and a repeat procedure was performed.There was nothing unusual about the procedure, but the patient was consistently coughing.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.
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Search Alerts/Recalls
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