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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, nephroscope
Product CodeFGA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Adverse Event Without Identified Device or Use Problem 7 7
Poor Quality Image 3 3
Material Separation 3 3
Crack 2 2
Optical Problem 2 2
Detachment of Device or Device Component 2 2
Metal Shedding Debris 2 2
No Display/Image 1 1
Mechanical Problem 1 1
Image Display Error/Artifact 1 1
Optical Distortion 1 1
Material Fragmentation 1 1
Material Twisted/Bent 1 1
Fracture 1 1
Device Operates Differently Than Expected 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Insufficient Information 6 6
Hemorrhage/Bleeding 5 5
Necrosis 4 4
Vascular Dissection 4 4
Increased Intra-Peritoneal Volume (IIPV) 4 4
Ischemia 4 4
Rupture 4 4
Cardiac Arrest 4 4
Thrombosis/Thrombus 4 4
Septic Shock 4 4
Disseminated Intravascular Coagulation (DIC) 4 4
Unspecified Kidney or Urinary Problem 4 4
Aneurysm 4 4
Hypoxia 4 4
Ascites 4 4
Respiratory Failure 4 4
No Known Impact Or Consequence To Patient 3 3
No Code Available 1 1
Inflammation 1 1
Foreign Body In Patient 1 1
No Patient Involvement 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Urinary Tract Infection 1 1

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