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Model Number FGS-0313 |
Device Problems
Loss of or Failure to Bond (1068); Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Date 05/20/2019 |
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, an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.During placement no lubrication was used, and the patient was gagging a little bit and there was nothing unusual about the procedure.However, the capsule failed to attach, and another capsule was used to proceed with the procedure.The cable at the rubber on the capsule was bent.No intervention was required, and a repeat procedure was performed.
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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.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, an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.During placement no lubrication was used, and the patient was gagging a little bit and there was nothing unusual about the procedure.However, the capsule failed to attach, and another capsule was used to proceed with the procedure.The customer also noted that the cable at the rubber on the capsule was bent.No intervention was required, and a repeat procedure was performed.The delivery system and capsule will be returned for investigation.
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Search Alerts/Recalls
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