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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
2020 23 23
2021 28 28
2022 40 40
2023 25 25
2024 20 20
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 56 56
Output Problem 52 52
Power Problem 20 20
Physical Resistance/Sticking 15 15
Break 11 11
Electrical /Electronic Property Problem 11 11
Intermittent Energy Output 8 8
Use of Device Problem 8 8
Intermittent Continuity 7 7
Blocked Connection 6 6
Material Frayed 5 5
Intermittent Loss of Power 4 4
Intermittent Capture 3 3
Scratched Material 2 2
Detachment of Device or Device Component 2 2
Appropriate Term/Code Not Available 2 2
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Problem 1 1
No Visual Prompts/Feedback 1 1
Collapse 1 1
Difficult to Fold, Unfold or Collapse 1 1
Unintended Movement 1 1
Material Fragmentation 1 1
Failure to Power Up 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 119
No Consequences Or Impact To Patient 16 16
Not Applicable 4 4
Intraoperative Pain 1 1
Swelling/ Edema 1 1

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