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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
Regulation Description Endoscope and accessories.
Product CodeFFS
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2020 56 56
2021 57 57
2022 10 10
2023 6 6
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 52 52
Overheating of Device 44 44
Protective Measures Problem 16 16
Unexpected Shutdown 16 16
Power Problem 6 6
Insufficient Information 4 4
Smoking 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Electrical /Electronic Property Problem 2 2
Defective Component 1 1
Image Display Error/Artifact 1 1
Poor Quality Image 1 1
Energy Output Problem 1 1
Optical Obstruction 1 1
Intermittent Energy Output 1 1
Break 1 1
Arcing 1 1
Sparking 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92 92
No Patient Involvement 31 31
No Known Impact Or Consequence To Patient 4 4
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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