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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 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 40 40
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 13 13
Peeled/Delaminated 4 4
Corroded 2 2
No Apparent Adverse Event 2 2
Device Dislodged or Dislocated 1 1
Break 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
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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