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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
Regulation Description Surgical camera and accessories.
Product CodeFWC
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2021 22 23
2022 17 17
2023 10 10
2024 5 5
2025 7 7
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 19 20
Break 18 19
Detachment of Device or Device Component 8 8
Crack 6 6
Material Integrity Problem 5 5
Mechanical Problem 4 4
Sparking 3 3
Loose or Intermittent Connection 3 4
Smoking 2 2
Excessive Heating 2 2
Connection Problem 2 2
Electrical /Electronic Property Problem 2 2
Temperature Problem 2 2
Disconnection 1 1
Collapse 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 56 57
Insufficient Information 3 3
Unspecified Tissue Injury 3 3
Burn(s) 2 2
Concussion 1 1

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