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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
Regulation Description Surgical camera and accessories.
Product CodeKQM
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2020 19 19
2021 9 9
2022 6 6
2023 10 10
2024 29 29
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 13 13
No Display/Image 11 11
Insufficient Information 8 8
Poor Quality Image 7 7
Break 5 5
Detachment of Device or Device Component 5 5
Device Fell 4 4
Fracture 4 4
Failure to Power Up 3 3
Power Problem 3 3
Electromagnetic Interference 3 3
Unexpected Shutdown 2 2
Image Display Error/Artifact 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Corroded 2 2
Loss of Power 2 2
Circuit Failure 1 1
Compatibility Problem 1 1
Crack 1 1
Electrical Power Problem 1 1
Collapse 1 1
Smoking 1 1
Solder Joint Fracture 1 1
Device Handling Problem 1 1
Connection Problem 1 1
Self-Activation or Keying 1 1
Intermittent Communication Failure 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 55 55
No Consequences Or Impact To Patient 9 9
Insufficient Information 6 6
No Known Impact Or Consequence To Patient 2 2
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

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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