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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device obturator, for endoscope
Product CodeFEC
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 1 1
2019 2 2
2020 1 1
2021 2 2
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Detachment Of Device Component 1 1
Crack 1 1
Flaked 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Foreign Body In Patient 1 1

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