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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
Product CodeHBT
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 9 9
2021 11 11
2022 15 15
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 19 19
Appropriate Term/Code Not Available 7 7
Failure to Align 6 6
Mechanical Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Material Twisted/Bent 3 3
Firing Problem 3 3
Difficult to Insert 2 2
Insufficient Information 2 2
Device Slipped 2 2
Failure to Fire 2 2
Corroded 1 1
Material Integrity Problem 1 1
Defective Component 1 1
Difficult to Open or Close 1 1
Defective Device 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
No Consequences Or Impact To Patient 12 12
Hemorrhage/Bleeding 5 5
Failure to Anastomose 3 3
No Code Available 3 3
Peritonitis 2 2
No Known Impact Or Consequence To Patient 2 2
Not Applicable 2 2
Foreign Body In Patient 1 1
Fistula 1 1
Ischemia 1 1
Perforation of Vessels 1 1

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