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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
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 47
2023 26 26
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 99 99
Optical Problem 86 86
Poor Quality Image 76 76
Unexpected Shutdown 16 16
Connection Problem 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Failure to Power Up 7 7
Overheating of Device 3 3
Thermal Decomposition of Device 2 2
Human-Device Interface Problem 2 2
Smoking 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Excessive Heating 2 2
Output Problem 1 1
Defective Device 1 1
Inadequate or Insufficient Training 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 124
No Consequences Or Impact To Patient 55 55
Burn(s) 5 5
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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