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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
2020 13 13
2021 6 6
2022 1 1
2023 11 11
2024 6 6
2025 5 5
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 21 21
Calcified 14 14
No Display/Image 13 13
Electrical Power Problem 2 2
Device Fell 2 2
Electrical Shorting 2 2
Material Frayed 1 1
Unstable 1 1
Sparking 1 1
Separation Problem 1 1
Break 1 1
Display Difficult to Read 1 1
Image Display Error/Artifact 1 1
Wireless Communication Problem 1 1
Positioning Problem 1 1
Optical Distortion 1 1
Insufficient Device Problem Information 1 1
Inadequacy of Device Shape and/or Size 1 1
Connection Problem 1 1
Optical Discoloration 1 1
Display or Visual Feedback Problem 1 1
Flaked 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 11 11
Insufficient Information 4 4
Perforation 1 1
Injury 1 1
Internal Organ Perforation 1 1

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