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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 4 4

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
Connection Problem 15 15
Adverse Event Without Identified Device or Use Problem 15 16
Unexpected Shutdown 12 12
Failure to Power Up 9 9
Overheating of Device 7 7
Break 5 5
Output Problem 4 4
Defective Device 4 4
Excessive Heating 4 4
Device-Device Incompatibility 3 3
Mechanical Problem 3 3
Smoking 3 5
No Device Output 2 2
Electrical /Electronic Property Problem 2 2
Corroded 2 2
Human-Device Interface Problem 2 2
Power Problem 2 2
Detachment of Device or Device Component 2 2
Thermal Decomposition of Device 2 2
Use of Device Problem 2 2
Failure to Clean Adequately 2 2
Leak/Splash 2 2
Energy Spectrum Incorrect 1 1
Poor Visibility 1 1
Material Separation 1 1
Activation Failure 1 1
Battery Problem 1 1
Inadequate or Insufficient Training 1 1
Defective Component 1 1
Insufficient Information 1 1
Complete Loss of Power 1 1
Image Display Error/Artifact 1 1
No Visual Prompts/Feedback 1 1
Fire 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 182 185
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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