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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device camera, television, surgical, with audio
Product CodeFWC
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2018 5 5
2019 1 1
2020 4 4
2021 22 22
2022 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 14 14
Device Fell 13 13
Detachment of Device or Device Component 5 5
Crack 5 5
Smoking 4 4
Device Emits Odor 3 3
Loose or Intermittent Connection 2 2
Connection Problem 2 2
Poor Quality Image 2 2
Excessive Heating 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Problem 1 1
Mechanical Problem 1 1
Loss of Power 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 3 3
No Consequences Or Impact To Patient 3 3
Unspecified Tissue Injury 2 2
No Patient Involvement 1 1
Irritation 1 1
Concussion 1 1

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