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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gastrointestinal motility system, capsule
Definition Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Product CodeNYV
Regulation Number 876.1725
Device Class 2

MDR Year MDR Reports MDR Events
2017 2 2
2019 2 2
2020 1 1
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 5 5
Loss of Data 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Application Program Shut Down 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 4 4
Radiation Exposure, Unintended 3 3
Unintended Radiation Exposure 1 1
Abdominal Pain 1 1
Urinary Tract Infection 1 1
Vomiting 1 1

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