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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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2024
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Device
kit, nephroscope
Product Code
FGA
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
SCHOELLY FIBEROPTIC, GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
2
2
2018
1
1
2019
1
1
2020
6
6
2022
1
1
2023
11
11
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
8
8
Poor Quality Image
3
3
Material Separation
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Optical Problem
2
2
Metal Shedding Debris
2
2
Detachment of Device or Device Component
2
2
Crack
2
2
No Display/Image
1
1
Fracture
1
1
Material Fragmentation
1
1
Image Display Error/Artifact
1
1
Mechanical Problem
1
1
Device Operates Differently Than Expected
1
1
Material Twisted/Bent
1
1
Optical Distortion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14
14
Insufficient Information
3
3
No Known Impact Or Consequence To Patient
3
3
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
Hemorrhage/Bleeding
1
1
Inflammation
1
1
Urinary Tract Infection
1
1
No Consequences Or Impact To Patient
1
1
No Patient Involvement
1
1
Foreign Body In Patient
1
1
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