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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device holder, camera, surgical
Regulation Description Surgical camera and accessories.
Product CodeFXR
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2020 14 14
2021 5 5
2022 37 38
2023 43 50
2024 17 18
2025 4 4
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 77 85
Peeled/Delaminated 18 19
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 13 13
Break 6 7
Corroded 6 6
Material Twisted/Bent 4 4
No Apparent Adverse Event 3 3
Crack 3 3
Fluid/Blood Leak 3 3
Device Dislodged or Dislocated 2 2
Moisture Damage 2 2
Material Split, Cut or Torn 1 2
Unstable 1 1
Solder Joint Fracture 1 1
Fracture 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 87
Brain Injury 26 26
No Patient Involvement 9 9
No Consequences Or Impact To Patient 7 7
Laceration(s) 4 4
Cerebral Edema 3 3
Skin Tears 1 2

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