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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
2019 17 17
2020 56 56
2021 57 57
2022 10 10
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 52 52
Overheating of Device 47 47
Protective Measures Problem 16 16
Unexpected Shutdown 15 15
Insufficient Information 10 10
Power Problem 6 6
Smoking 2 2
No Apparent Adverse Event 2 2
Electrical /Electronic Property Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Sparking 1 1
No Display/Image 1 1
Break 1 1
Image Display Error/Artifact 1 1
Poor Quality Image 1 1
Electrical Power Problem 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Electrical Shorting 1 1
Device Emits Odor 1 1
Melted 1 1
Optical Obstruction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88 88
No Patient Involvement 33 33
No Known Impact Or Consequence To Patient 19 19
No Information 3 3
No Consequences Or Impact To Patient 2 2
Full thickness (Third Degree) Burn 2 2
Insufficient Information 1 1
Laceration(s) 1 1
Partial thickness (Second Degree) Burn 1 1

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