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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lithotriptor, extracorporeal shock-wave, urological
Product CodeLNS
Regulation Number 876.5990
Device Class 2


Premarket Reviews
ManufacturerDecision
DORNIER MEDTECH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
LITE-MED INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 60 60
2020 38 38
2021 55 55
2022 52 52
2023 86 86
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 299 299
Device Displays Incorrect Message 4 4
Improper or Incorrect Procedure or Method 3 3
Mechanical Problem 2 2
Failure to Power Up 2 2
Use of Device Problem 2 2
Loss of Power 2 2
Fluid/Blood Leak 2 2
Failure to Deliver Energy 1 1
Intermittent Energy Output 1 1
Energy Output Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Smoking 1 1
Defective Component 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Output above Specifications 1 1
Patient Device Interaction Problem 1 1
Gas/Air Leak 1 1
Charging Problem 1 1
Power Conditioning Problem 1 1
Appropriate Term/Code Not Available 1 1
Intermittent Continuity 1 1
Failure to Deliver Shock/Stimulation 1 1
Display or Visual Feedback Problem 1 1
Intermittent Shock/Stimulation 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematoma 295 295
No Known Impact Or Consequence To Patient 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 7 7
Rupture 4 4
Death 3 3
Unspecified Kidney or Urinary Problem 3 3
No Consequences Or Impact To Patient 3 3
Patient Problem/Medical Problem 2 2
Hematuria 2 2
No Code Available 1 1
Injury 1 1
No Patient Involvement 1 1
Hypoxia 1 1
Hemorrhage/Bleeding 1 1

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