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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device camera, television, surgical, without audio
Regulation Description Surgical camera and accessories.
Product CodeFWB
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2021 6 6
2022 1 1
2023 11 11
2024 6 6
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 15 15
Output Problem 9 9
Device Fell 3 3
Electrical Power Problem 2 2
Electrical Shorting 2 2
Melted 2 2
Material Frayed 1 1
Sparking 1 1
Separation Problem 1 1
Break 1 1
Image Display Error/Artifact 1 1
Poor Quality Image 1 1
Wireless Communication Problem 1 1
Optical Distortion 1 1
Optical Discoloration 1 1
Overheating of Device 1 1
Display or Visual Feedback Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
Insufficient Information 4 4
Perforation 1 1
Internal Organ Perforation 1 1

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