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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
Product CodeFXR
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 14 14
2021 5 5
2022 37 37
2023 45 45
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 76 76
Peeled/Delaminated 17 17
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 13 13
Break 5 5
Corroded 5 5
Crack 3 3
Fluid/Blood Leak 3 3
No Apparent Adverse Event 3 3
Material Split, Cut or Torn 1 1
Moisture Damage 1 1
Unstable 1 1
Solder Joint Fracture 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 71
Brain Injury 26 26
No Patient Involvement 9 9
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 3 3

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