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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, pneumoperitoneum, automatic
Product CodeFDP
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 3 3
2021 1 1
2022 7 7
2023 6 6
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 5 5
Appropriate Term/Code Not Available 5 5
Patient Device Interaction Problem 4 4
Insufficient Information 4 4
Difficult to Open or Remove Packaging Material 3 3
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Jam 1 1
Break 1 1
Material Disintegration 1 1
Retraction Problem 1 1
Use of Device Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Form Staple 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Consequences Or Impact To Patient 5 5
Hemorrhage/Bleeding 3 3
Unspecified Tissue Injury 2 2
Insufficient Information 2 2
Pneumothorax 1 1

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