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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
device, biopsy, endomyocardial
Product Code
DWZ
Regulation Number
870.4075
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
5
5
2020
5
5
2021
5
5
2022
14
14
2023
11
11
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
14
14
Break
6
6
Physical Resistance/Sticking
5
5
Difficult to Open or Close
5
5
Mechanical Problem
4
4
Failure to Obtain Sample
2
2
Therapeutic or Diagnostic Output Failure
2
2
Difficult to Remove
2
2
Mechanics Altered
2
2
Detachment of Device or Device Component
2
2
Activation Failure
2
2
Fracture
2
2
Mechanical Jam
2
2
Output Problem
1
1
Defective Component
1
1
Protective Measures Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
16
16
Insufficient Information
8
8
Cardiac Tamponade
7
7
No Known Impact Or Consequence To Patient
4
4
Cardiac Perforation
4
4
Perforation of Vessels
3
3
Pericardial Effusion
2
2
Tachycardia
2
2
Arrhythmia
1
1
Embolism/Embolus
1
1
Ventricular Fibrillation
1
1
Thrombosis/Thrombus
1
1
Discomfort
1
1
Unspecified Tissue Injury
1
1
No Consequences Or Impact To Patient
1
1
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