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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, surgical and accessories
Product CodeKQM
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2017 5 5
2018 8 8
2019 6 6
2020 19 19
2021 9 9
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 7 7
Poor Quality Image 7 7
Insufficient Information 5 5
Device Fell 5 5
Detachment of Device or Device Component 4 4
No Display/Image 4 4
Break 4 4
Collapse 2 2
Misconnection 2 2
Corroded 2 2
Smoking 2 2
Structural Problem 2 2
Unexpected Shutdown 2 2
Power Problem 2 2
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Connection Problem 1 1
Unstable 1 1
Electrical Power Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Crack 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Circuit Failure 1 1
Fracture 1 1
Image Display Error/Artifact 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 10 10
No Information 2 2
No Patient Involvement 2 2
Patient Problem/Medical Problem 1 1
Anxiety 1 1
Bruise/Contusion 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Pain 1 1
Insufficient Information 1 1
Not Applicable 1 1

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