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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device image, illumination, fiberoptic, for endoscope
Product CodeFFS
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2018 19 19
2019 17 17
2020 56 56
2021 57 57
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 52 52
Overheating of Device 49 49
Protective Measures Problem 16 16
Unexpected Shutdown 14 14
Insufficient Information 8 8
Power Problem 8 8
Loss of Power 4 4
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Noise, Audible 2 2
Defective Component 2 2
Break 2 2
Thermal Decomposition of Device 2 2
No Display/Image 2 2
Electrical /Electronic Property Problem 1 1
Fire 1 1
Image Display Error/Artifact 1 1
Melted 1 1
Poor Quality Image 1 1
Device Emits Odor 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Device Operates Differently Than Expected 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Inadequate Lighting 1 1
Smoking 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Optical Obstruction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83 83
No Known Impact Or Consequence To Patient 35 35
No Patient Involvement 33 33
Full thickness (Third Degree) Burn 3 3
No Information 3 3
No Consequences Or Impact To Patient 2 2
Blurred Vision 1 1
No Code Available 1 1

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