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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 13 13
No Display/Image 8 8
Poor Quality Image 7 7
Break 6 6
Insufficient Information 6 6
Fracture 5 5
Device Fell 4 4
Detachment of Device or Device Component 4 4
Power Problem 3 3
Failure to Power Up 3 3
Loss of Power 2 2
Collapse 2 2
Corroded 2 2
Electromagnetic Interference 2 2
Unexpected Shutdown 2 2
Device Handling Problem 1 1
Noise, Audible 1 1
Electrical Power Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Loss of or Failure to Bond 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
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
2 Baxter Healthcare Corporation II Jul-05-2024
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