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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, with audio
Product CodeFWC
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 4 4
2021 22 22
2022 17 17
2023 10 10
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 17 17
Break 16 16
Detachment of Device or Device Component 6 6
Crack 6 6
Mechanical Problem 5 5
Material Integrity Problem 5 5
Smoking 3 3
Loose or Intermittent Connection 3 3
Temperature Problem 2 2
Connection Problem 2 2
Collapse 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Problem 1 1
Melted 1 1
Poor Quality Image 1 1
Device Emits Odor 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Image Display Error/Artifact 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
Insufficient Information 3 3
No Consequences Or Impact To Patient 3 3
Unspecified Tissue Injury 2 2
No Patient Involvement 1 1
Irritation 1 1
Concussion 1 1

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