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TPLC
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Device
kit, nephroscope
Regulation Description
Endoscope and accessories.
Product Code
FGA
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
KARL STORZ SE & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
6
6
2022
1
1
2023
11
11
2024
23
23
2025
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
20
20
Adverse Event Without Identified Device or Use Problem
9
9
Crack
3
3
Optical Problem
2
2
Component Missing
2
2
Poor Quality Image
2
2
Detachment of Device or Device Component
2
2
Fracture
1
1
Optical Distortion
1
1
Material Integrity Problem
1
1
Mechanical Problem
1
1
Material Twisted/Bent
1
1
No Display/Image
1
1
Image Display Error/Artifact
1
1
Material Separation
1
1
Improper or Incorrect Procedure or Method
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
32
32
Insufficient Information
6
6
Hemorrhage/Bleeding
5
5
Unspecified Kidney or Urinary Problem
4
4
Thrombosis/Thrombus
4
4
Ischemia
4
4
Hypoxia
4
4
Disseminated Intravascular Coagulation (DIC)
4
4
Septic Shock
4
4
Increased Intra-Peritoneal Volume (IIPV)
4
4
Necrosis
4
4
Cardiac Arrest
4
4
Respiratory Failure
4
4
Rupture
4
4
Ascites
4
4
Aneurysm
4
4
Vascular Dissection
4
4
Foreign Body In Patient
1
1
No Patient Involvement
1
1
Inflammation
1
1
Urinary Tract Infection
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Karl Storz Endoscopy
II
Sep-24-2024
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