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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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Optical Problem 69 69
Poor Quality Image 68 69
Appropriate Device Problem 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 10 10
Overheating of Device 6 6
Break 5 5
Excessive Heating 4 4
Defective Device 4 4
Output Problem 4 4
Smoking 3 5
Device-Device Incompatibility 3 3
Electrical /Electronic Property Problem 3 3
Mechanical Problem 3 3
Human-Device Interface Problem 2 2
Leak/Splash 2 2
Use of Device Problem 2 2
Complete Loss of Power 2 2
Power Problem 2 2
Failure to Clean Adequately 2 2
Activation Failure 2 2
No Device Output 2 2
Corroded 2 2
Inadequate or Insufficient Training 1 1
No Apparent Adverse Event 1 1
Loose or Intermittent Connection 1 1
Energy Spectrum Incorrect 1 1
Image Display Error/Artifact 1 1
Poor Visibility 1 1
Temperature Problem 1 1
No Visual Prompts/Feedback 1 1
Intermittent Loss of Power 1 1
Activation Problem 1 1
Detachment of Device or Device Component 1 1
Fire 1 1
Insufficient Device Problem Information 1 1
Intermittent Communication Failure 1 1
Display or Visual Feedback Problem 1 1
Defective Component 1 1
Improper or Incorrect Procedure or Method 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 190 193
Burn(s) 9 9
Superficial (First Degree) Burn 4 4
No Consequences Or Impact To Patient 3 3
Blister 1 1
Bradycardia 1 1
Insufficient Information 1 1

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