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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
Product CodeFWF
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2019 40 40
2020 23 23
2021 28 28
2022 40 40
2023 25 25
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 44 44
Output Problem 36 36
Intermittent Continuity 24 24
Power Problem 18 18
Physical Resistance/Sticking 13 13
Electrical /Electronic Property Problem 13 13
Break 11 11
Intermittent Loss of Power 10 10
Intermittent Energy Output 10 10
Use of Device Problem 6 6
Blocked Connection 6 6
Intermittent Capture 6 6
Poor Quality Image 3 3
Material Frayed 3 3
Image Display Error/Artifact 2 2
Detachment of Device or Device Component 2 2
Intermittent Communication Failure 2 2
Operating System Becomes Nonfunctional 2 2
No Visual Prompts/Feedback 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Component or Accessory Incompatibility 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Image Orientation Incorrect 1 1
Mechanical Problem 1 1
Failure to Power Up 1 1
Sensing Intermittently 1 1
No Display/Image 1 1
Collapse 1 1
Computer Software Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 98 98
No Consequences Or Impact To Patient 42 42
Not Applicable 14 14
No Code Available 5 5
Swelling/ Edema 1 1
Intraoperative Pain 1 1
No Known Impact Or Consequence To Patient 1 1

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