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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
2018
7
7
2019
5
5
2020
5
5
2021
5
5
2022
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
11
11
Break
7
7
Difficult to Open or Close
6
6
Mechanical Problem
3
3
Difficult to Remove
2
2
Mechanics Altered
2
2
Physical Resistance/Sticking
2
2
Defective Component
1
1
Component Missing
1
1
Failure to Obtain Sample
1
1
Defective Device
1
1
Malposition of Device
1
1
Detachment of Device or Device Component
1
1
Difficult to Open or Remove Packaging Material
1
1
Corroded
1
1
Fracture
1
1
Output Problem
1
1
Protective Measures Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
8
8
No Known Impact Or Consequence To Patient
6
6
Cardiac Tamponade
5
5
Insufficient Information
4
4
Perforation of Vessels
3
3
No Consequences Or Impact To Patient
3
3
Cardiac Perforation
2
2
No Code Available
2
2
Pericardial Effusion
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Foreign Body In Patient
1
1
Ventricular Fibrillation
1
1
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