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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, irrigation, urological
Product CodeLJH
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
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

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