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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clip, hemostatic
Regulation Description Implantable clip.
Product CodeMCH
Regulation Number 878.4300
Device Class 2

MDR Year MDR Reports MDR Events
2021 27 27
2022 125 125
2023 1 2

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 149 150
Break 11 11
Use of Device Problem 10 11
Difficult to Open or Close 7 7
Material Deformation 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Premature Activation 4 4
Entrapment of Device 3 3
Positioning Failure 3 3
Detachment of Device or Device Component 2 2
Defective Device 1 1
Material Twisted/Bent 1 1
Failure to Advance 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 148 149
Hemorrhage/Bleeding 5 5
No Consequences Or Impact To Patient 3 3
Abdominal Pain 1 1
Syncope/Fainting 1 1
Dizziness 1 1
Anemia 1 1
Ulcer 1 1

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