Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Back to Search Results
Device
system, irrigation, urological
Product Code
LJH
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
KARL STORZ ENDOSCOPY AMERICA, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
19
19
2018
18
18
2019
16
16
2020
23
23
2021
15
15
2022
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid Leak
26
26
Device Contamination with Chemical or Other Material
11
11
Leak/Splash
7
7
Break
5
5
Free or Unrestricted Flow
5
5
Improper Flow or Infusion
5
5
No Flow
5
5
Tear, Rip or Hole in Device Packaging
4
4
Fitting Problem
3
3
Detachment of Device or Device Component
3
3
Disconnection
3
3
Filling Problem
3
3
Device Packaging Compromised
3
3
Incomplete or Inadequate Connection
3
3
Smoking
2
2
Backflow
2
2
Defective Component
2
2
Component Missing
2
2
Device Operates Differently Than Expected
1
1
Failure to Disconnect
1
1
Defective Device
1
1
Contamination /Decontamination Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Packaging Problem
1
1
Protective Measures Problem
1
1
Physical Resistance/Sticking
1
1
Material Twisted/Bent
1
1
Partial Blockage
1
1
Material Discolored
1
1
Improper or Incorrect Procedure or Method
1
1
Loose or Intermittent Connection
1
1
Mechanical Problem
1
1
Delivered as Unsterile Product
1
1
Failure to Prime
1
1
Reflux within Device
1
1
Device Remains Activated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
35
35
No Known Impact Or Consequence To Patient
20
20
No Consequences Or Impact To Patient
17
17
No Clinical Signs, Symptoms or Conditions
17
17
Insufficient Information
2
2
Rupture
1
1
Abdominal Distention
1
1
No Information
1
1
Air Embolism
1
1
Cardiac Arrest
1
1
Death
1
1
Pain
1
1
-
-