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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
Regulation Description Extracorporeal shock wave lithotripter.
Product CodeLNS
Regulation Number 876.5990
Device Class 2


Premarket Reviews
ManufacturerDecision
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
LITE-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WIKKON PRECISION TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SONOMOTION, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 38 38
2021 55 55
2022 52 52
2023 86 86
2024 40 40
2025 61 61
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 319 319
Misfocusing 3 3
Improper or Incorrect Procedure or Method 3 3
Use of Device Problem 3 3
Appropriate Device Problem Term/Code Not Available 2 2
Failure to Deliver Energy 1 1
Energy Output Problem 1 1
Insufficient Device Problem Information 1 1
Output above Specifications 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematoma 322 322
Insufficient Information 10 10
No Clinical Signs, Symptoms or Conditions 9 9
Rupture 5 5
Unspecified Kidney or Urinary Problem 3 3
No Known Impact Or Consequence To Patient 3 3
Hematuria 2 2
Kidney injury 2 2
Hypoxia 1 1
Unspecified Skin and Subcutaneous Tissue Problem 1 1
Death 1 1
No Code Available 1 1

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