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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device camera, surgical and accessories
Product CodeKQM
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2018 8 8
2019 6 6
2020 19 19
2021 9 9
2022 6 6
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 8 8
Poor Quality Image 7 7
Insufficient Information 5 5
Device Fell 5 5
No Display/Image 4 4
Break 4 4
Detachment of Device or Device Component 3 3
Corroded 2 2
Collapse 2 2
Power Problem 2 2
Failure to Power Up 2 2
Structural Problem 2 2
Unexpected Shutdown 2 2
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Connection Problem 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
Misconnection 1 1
Crack 1 1
Loss of Power 1 1
Electrical Power Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
No Consequences Or Impact To Patient 13 13
No Known Impact Or Consequence To Patient 9 9
No Information 2 2
Insufficient Information 1 1
Not Applicable 1 1
No Patient Involvement 1 1
Patient Problem/Medical Problem 1 1
Bruise/Contusion 1 1
Bone Fracture(s) 1 1
Head Injury 1 1

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