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Model Number FGS-0313 |
Device Problems
Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
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Patient Problems
Hemorrhage/Bleeding (1888); Discomfort (2330)
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Event Date 05/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: na/others.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 detach from the delivery device.There was some mild discomfort to the patient and a tiny amount of blood in the suction and on the drapes.Further observation as intervention was required following minimal bleeding, but the patient is stable and there was no harm to anybody, and a repeat procedure was performed as the procedure was terminated at the time of incident.They used a third capsule, but the patient was unable to tolerate the third attempt.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.A lubricant was used to facilitate placement of the capsule and the capsule was cleaned thoroughly with disinfectant wipes and will be returned together with the delivery device for investigation.
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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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Manufacturer Narrative
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Additional: (street 1, mfr.City, region, postal code),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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Search Alerts/Recalls
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