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Model Number FGS-0313 |
Device Problems
Loss of or Failure to Bond (1068); Structural Problem (2506)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 06/22/2018 |
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 no repeat procedure was performed.They opened another capsule and placed it to continue the procedure.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 and capsule will be returned for investigation.
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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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Manufacturer Narrative
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Evaluation summary: this report is based on information provided by medtronic investigation personnel and the sample that arrived.One bravo capsule and one bravo delivery device were received for evaluation.This device has been used in the diagnosis of a patient.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.Additional information: (evaluation summary) corrected information: (evaluation code - method, evaluation code-result, evaluation code-conclusion).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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