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Model Number FGS-0313 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Inflammation (1932); No Consequences Or Impact To Patient (2199)
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Event Date 08/26/2019 |
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.They retrieved the capsule using a basket and prepared another capsule, but the physician decided not to continue the procedure due to the failed first attempt and patient's esophagitis.There was no harm to the patient, they pulled the capsule out, and no repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy was performed to confirm the placement of the capsule using an endoscope prior to the procedure and showed the esophagus to be normal.A lubricant was used to facilitate placement of the capsule and the delivery system and the 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 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, they had a capsule which failed to attach.They retrieved the capsule using a basket and prepared another capsule, but the physician decided not to continue the procedure due to the failed first attempt and patient's esophagitis that was related to the procedure.There was no harm to the patient, they pulled the capsule out, and no repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy was performed to confirm the placement of the capsule using an endoscope prior to the procedure and showed the esophagus to be normal.A lubricant 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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Event Description
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According to the reporter, they had a capsule which failed to attach.They retrieved the capsule using a basket and prepared another capsule, but the physician decided not to continue the procedure due to the failed first attempt and patient's esophagitis that was related to the procedure.There was no harm to the patient, they pulled the capsule out, and no repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy was performed to confirm the placement of the capsule using an endoscope prior to the procedure and showed the esophagus to be normal.A lubricant was used to facilitate placement of the capsule and the delivery system and capsule will be returned for investigation.
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Search Alerts/Recalls
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