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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applier, hemostatic clip
Regulation Description Manual surgical instrument for general use.
Product CodeHBT
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 9 9
2021 11 11
2022 15 15
2023 4 4
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 16 16
Mechanical Problem 8 8
Appropriate Term/Code Not Available 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Failure to Align 5 5
Material Twisted/Bent 3 3
Firing Problem 3 3
Difficult to Insert 3 3
Failure to Fire 2 2
Difficult to Open or Close 2 2
Insufficient Information 2 2
Material Integrity Problem 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Consequences Or Impact To Patient 8 8
Hemorrhage/Bleeding 5 5
No Known Impact Or Consequence To Patient 1 1
Foreign Body In Patient 1 1
Perforation of Vessels 1 1

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