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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applier, aneurysm clip
Product CodeHCI
Regulation Number 882.4175
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC
  SUBSTANTIALLY EQUIVALENT 1
MIZUHO AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 2 2
2021 6 6
2022 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 4 4
Failure to Form Staple 3 3
Device Fell 3 3
Compatibility Problem 2 2
Failure to Fire 2 2
Difficult to Open or Close 1 1
Material Deformation 1 1
Mechanical Jam 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
No Known Impact Or Consequence To Patient 4 4
Hemorrhage/Bleeding 2 2
Intracranial Hemorrhage 2 2
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Peter Lazic Gmbh II Mar-11-2024
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