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Model Number FGS-0313 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Blood Loss (2597)
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Event Date 02/15/2019 |
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, the capsule attached, but it did not detach from the delivery system.The capsule had to be completely removed from the mucosa of the esophagus.The patient had a minute bleeding on the site, no intervention was required, and another capsule was used to proceed with 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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Additional information: 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.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 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.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 first capsule failed to calibrate.A second capsule was used, it attached but it did not detach from the delivery system.The capsule had to be completely removed from the mucosa of the esophagus.The patient had a minute bleeding on the site, no intervention was required to stop the bleeding, and a third capsule was used to proceed with 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.
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Search Alerts/Recalls
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