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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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 63 63
Output Problem 53 53
Power Problem 22 22
Physical Resistance/Sticking 15 15
Electrical /Electronic Property Problem 12 12
Break 11 11
Use of Device Problem 10 10
Blocked Connection 9 9
Intermittent Energy Output 8 8
Intermittent Continuity 7 7
Material Frayed 5 5
Intermittent Loss of Power 4 4
Scratched Material 3 3
Intermittent Capture 3 3
Detachment of Device or Device Component 3 3
Device Contaminated During Manufacture or Shipping 2 2
Appropriate Term/Code Not Available 2 2
Mechanical Problem 1 1
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
Material Fragmentation 1 1
Failure to Power Up 1 1
Computer Software Problem 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 131 131
No Consequences Or Impact To Patient 16 16
Not Applicable 4 4
Intraoperative Pain 1 1
Swelling/ Edema 1 1

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