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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device led light source
Regulation Description Endoscope and accessories.
Definition Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
Product CodeNTN
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 47 47
2022 47 49
2023 26 27
2024 32 32
2025 42 42
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Optical Problem 69 69
Poor Quality Image 66 67
Appropriate Term/Code Not Available 47 47
Adverse Event Without Identified Device or Use Problem 15 16
Connection Problem 15 15
Unexpected Shutdown 12 12
Failure to Power Up 9 9
Overheating of Device 7 7
Break 4 4
Output Problem 4 4
Defective Device 4 4
Excessive Heating 4 4
Device-Device Incompatibility 3 3
Mechanical Problem 3 3
Smoking 3 5
Leak/Splash 2 2
Failure to Clean Adequately 2 2
Use of Device Problem 2 2
Thermal Decomposition of Device 2 2
Detachment of Device or Device Component 2 2
Power Problem 2 2
Human-Device Interface Problem 2 2
Electrical /Electronic Property Problem 2 2
No Device Output 2 2
No Visual Prompts/Feedback 1 1
Image Display Error/Artifact 1 1
Insufficient Information 1 1
Defective Component 1 1
Battery Problem 1 1
Energy Spectrum Incorrect 1 1
Material Separation 1 1
Activation Failure 1 1
Inadequate or Insufficient Training 1 1
Complete Loss of Power 1 1
Corroded 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Intermittent Loss of Power 1 1
Intermittent Communication Failure 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 179 182
Burn(s) 9 9
Superficial (First Degree) Burn 4 4
No Consequences Or Impact To Patient 3 3
Blister 1 1
Insufficient Information 1 1
Bradycardia 1 1

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