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Model Number FGS-0109-J |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/29/2024 |
Event Type
Injury
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Manufacturer Narrative
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D10 concomitant product: unk - pillcam, unknown pillcam (lot#unknown) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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According to the reporter, the patient swallowed a patency capsule, and no discharge was observed after two days, so the location was confirmed by x-ray.It could not be confirmed with x-ray imaging, and discharge was determined as there was also excretion during that time.After five days, the test was conducted, but the patient visited the hospital two days after due to abdominal pain.Upon checking the ct scan, it was observed that the small bowel capsule was stuck in the stenosis site.The outer film of the small bowel capsule was collected and the patency capsule using an endoscope.The patient was prepped for the procedure.The patient was hospitalized for four days.
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Search Alerts/Recalls
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