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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2021 28 28
2022 40 40
2023 25 25
2024 20 20
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 67 67
Output Problem 61 61
Power Problem 23 23
Physical Resistance/Sticking 17 17
Use of Device Problem 10 10
Blocked Connection 10 10
Electrical /Electronic Property Problem 9 9
Intermittent Energy Output 8 8
Break 6 6
Material Frayed 5 5
Intermittent Loss of Power 4 4
Scratched Material 3 3
Device Contaminated During Manufacture or Shipping 2 2
Mechanical Problem 2 2
Computer Software Problem 2 2
Appropriate Term/Code Not Available 2 2
No Visual Prompts/Feedback 1 1
Electrical Power Problem 1 1
Collapse 1 1
Difficult to Fold, Unfold or Collapse 1 1
Unintended Movement 1 1
Intermittent Capture 1 1
Degraded 1 1
Material Fragmentation 1 1
Detachment of Device or Device Component 1 1
Complete Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 139 139
Intraoperative Pain 1 1
Swelling/ Edema 1 1

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