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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device colon capsule imaging system
Regulation Description Colon capsule endoscopy system.
Definition visualization of the colon for the detection of polyps
Product CodePGD
Regulation Number 876.1330
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 3 3
2022 2 2
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 2 2
Material Fragmentation 1 1
Patient-Device Incompatibility 1 1
Human-Device Interface Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Patient Device Interaction 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 2 2
Pain 2 2
Unintended Radiation Exposure 2 2
Abdominal Pain 1 1
Arthralgia 1 1
Fatigue 1 1
Nausea 1 1
No Code Available 1 1
Dizziness 1 1
Inflammation 1 1
Confusion/ Disorientation 1 1
Paresthesia 1 1
Fever 1 1
Diarrhea 1 1
Numbness 1 1
Unspecified Eye / Vision Problem 1 1
Insufficient Information 1 1
Dyspnea 1 1
Choking 1 1
Anxiety 1 1
Irritability 1 1
Constipation 1 1
Low Blood Pressure/ Hypotension 1 1
Lethargy 1 1

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