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Model Number DSL-19-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Radiation Exposure, Unintended (3164)
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Event Date 06/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Title: comparison of two specialized histology needles for endoscopic ultrasound (eus)-guided liver biopsy: a pilot study source: digestive diseases and sciences https://doi.Org/10.1007/s10620-020-06391-3, received: 22 april 2020 / accepted: 3 june 2020 springer science+business media, llc, part of springer nature 2020.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 literature source of the study performed, from october, 2018 to september 2019.Two of the patients form the same study had a biopsy using the competitors and company's device.Both patients reported an abdominal pain after the operation and had a ct-scan, which showed no abnormal finding.The patients stayed overnight for observation and were discharged the next morning after their pain was controlled by medication.
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Search Alerts/Recalls
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