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TPLC
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show TPLC since
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Device
clip, aneurysm
Product Code
HCH
Regulation Number
882.5200
Device Class
2
Premarket Reviews
Manufacturer
Decision
MIZUHO AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
PETER LAZIC GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
9
9
2020
9
9
2021
13
13
2022
1
1
2023
10
10
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Seal
15
15
Mechanical Problem
6
6
Material Integrity Problem
4
4
Loosening of Implant Not Related to Bone-Ingrowth
4
4
Improper or Incorrect Procedure or Method
4
4
Migration or Expulsion of Device
3
3
Patient Device Interaction Problem
3
3
Difficult to Open or Close
3
3
Break
2
2
Defective Component
2
2
Positioning Problem
2
2
Material Twisted/Bent
2
2
Component or Accessory Incompatibility
1
1
Activation Problem
1
1
Difficult to Fold, Unfold or Collapse
1
1
Insufficient Information
1
1
Wrong Label
1
1
Device Difficult to Setup or Prepare
1
1
Failure to Align
1
1
Material Deformation
1
1
Product Quality Problem
1
1
Fracture
1
1
Device Dislodged or Dislocated
1
1
Failure to Form Staple
1
1
Firing Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22
22
Insufficient Information
8
8
No Consequences Or Impact To Patient
8
8
No Known Impact Or Consequence To Patient
5
5
Aneurysm
5
5
Patient Problem/Medical Problem
2
2
Failure of Implant
2
2
Brain Injury
1
1
No Code Available
1
1
Foreign Body Reaction
1
1
Swelling
1
1
Ruptured Aneurysm
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Peter Lazic Gmbh
II
Mar-12-2024
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