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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 28 28
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 79 79
Output Problem 70 70
Power Problem 28 28
Physical Resistance/Sticking 20 20
Electrical /Electronic Property Problem 15 15
Blocked Connection 12 12
Use of Device Problem 11 11
Break 11 11
Intermittent Energy Output 8 8
Intermittent Continuity 7 7
Appropriate Device Problem Term/Code Not Available 5 5
Material Frayed 5 5
Intermittent Loss of Power 4 4
Scratched Material 3 3
Detachment of Device or Device Component 3 3
Intermittent Capture 3 3
Device Contaminated During Manufacture or Shipping 2 2
Mechanical Problem 2 2
Computer Software Problem 2 2
Degraded 1 1
Material Fragmentation 1 1
Electrical Power Problem 1 1
Collapse 1 1
Unintended Movement 1 1
Complete Loss of Power 1 1
Failure to Power Up 1 1
Difficult to Fold, Unfold or Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 161 161
No Consequences Or Impact To Patient 16 16
Not Applicable 4 4
Swelling/ Edema 1 1
Intraoperative Pain 1 1

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