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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 26 26

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 49
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 6 6
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Not Applicable 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
No Patient Involvement 1 1
Bruise/Contusion 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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