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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, ent
Product CodeKAE
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 8 8
2016 5 5
2017 3 3
2018 1 1
2019 1 1
2021 4 4
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Material Fragmentation 5 5
Device Operates Differently Than Expected 3 3
Mechanical Problem 2 2
Device Reprocessing Problem 2 2
Detachment Of Device Component 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Fracture 2 2
Physical Resistance 2 2
Detachment of Device or Device Component 1 1
Bent 1 1
Component Missing 1 1
High Sensing Threshold 1 1
Entrapment of Device 1 1
Migration or Expulsion of Device 1 1
Increase in Pressure 1 1
Difficult to Remove 1 1
Difficult to Open or Close 1 1
Scratched Material 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
Injury 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Pain 4 4
No Consequences Or Impact To Patient 3 3
Foreign Body In Patient 3 3
Insufficient Information 2 2
Cerebrospinal Fluid Leakage 1 1
Device Embedded In Tissue or Plaque 1 1
Brain Injury 1 1
No Patient Involvement 1 1

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