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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
2021 57 57
2022 10 10
2023 6 6
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 37 37
Failure to Power Up 21 21
Protective Measures Problem 13 13
Unexpected Shutdown 9 9
Insufficient Information 3 3
Smoking 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Electrical /Electronic Property Problem 2 2
Break 1 1
Image Display Error/Artifact 1 1
Poor Quality Image 1 1
Intermittent Energy Output 1 1
Energy Output Problem 1 1
Optical Obstruction 1 1
Arcing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
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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