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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
2020 56 56
2021 47 47
2022 47 49
2023 26 27
2024 32 32
2025 42 42
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 100 100
Optical Problem 94 94
Poor Quality Image 90 91
Unexpected Shutdown 17 17
Connection Problem 16 16
Adverse Event Without Identified Device or Use Problem 16 17
Failure to Power Up 12 12
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
Improper or Incorrect Procedure or Method 3 3
Mechanical Problem 3 3
Smoking 3 5
No Device Output 2 2
Electrical /Electronic Property Problem 2 2
Corroded 2 2
Complete Loss of Power 2 2
Human-Device Interface Problem 2 2
Power Problem 2 2
Activation Failure 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
Fire 2 2
Leak/Splash 2 2
Material Separation 1 1
Poor Visibility 1 1
Energy Spectrum Incorrect 1 1
Battery Problem 1 1
Inadequate or Insufficient Training 1 1
Inadequate Instructions for Healthcare Professional 1 1
Defective Component 1 1
Insufficient Information 1 1
Image Display Error/Artifact 1 1
No Visual Prompts/Feedback 1 1
Loose or Intermittent Connection 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 195 198
No Consequences Or Impact To Patient 55 55
Burn(s) 10 10
Superficial (First Degree) Burn 4 4
No Known Impact Or Consequence To Patient 2 2
Blister 1 1
Insufficient Information 1 1
Bradycardia 1 1

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