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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
2019 6 6
2020 19 19
2021 9 9
2022 6 6
2023 10 10
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 12 12
No Display/Image 8 8
Poor Quality Image 7 7
Insufficient Information 6 6
Break 6 6
Fracture 5 5
Detachment of Device or Device Component 4 4
Device Fell 4 4
Power Problem 3 3
Failure to Power Up 3 3
Electromagnetic Interference 2 2
Collapse 2 2
Corroded 2 2
Loss of Power 2 2
Unexpected Shutdown 2 2
Noise, Audible 1 1
Crack 1 1
Circuit Failure 1 1
Image Display Error/Artifact 1 1
Smoking 1 1
Solder Joint Fracture 1 1
Structural Problem 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 41 41
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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

Recalls
Manufacturer Recall Class Date Posted
1 Barco N.V. II Feb-02-2024
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