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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
Regulation Description Endoscope and accessories.
Product CodeFDP
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 7 7
2023 6 6
2024 22 22
2025 16 16
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 29 29
Delivered as Unsterile Product 8 8
Patient Device Interaction Problem 6 6
Insufficient Information 4 4
Break 2 2
Difficult to Open or Remove Packaging Material 2 2
Improper Flow or Infusion 2 2
Malposition of Device 1 1
Communication or Transmission Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Microbial Contamination of Device 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Hemorrhage/Bleeding 5 5
Unspecified Tissue Injury 4 4
Insufficient Information 3 3
Pneumothorax 1 1

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