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 Information (3190)
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Event Date 04/30/2019 |
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 reported patient outcome.
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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 as they used another capsule to complete 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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Evaluation summary: this report is based on information provided by medtronic investigation personnel.Bravo device was received for evaluation.The customer reported that they have a capsule which failed to attach.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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