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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lithotriptor, electro-hydraulic
Product CodeFFK
Regulation Number 876.4480
Device Class 2


Premarket Reviews
ManufacturerDecision
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
WALZ ELEKTRONIK GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 39 39
2021 22 22
2022 13 13
2023 10 10
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 25 25
Output Problem 14 14
No Device Output 11 11
Detachment of Device or Device Component 9 9
Insufficient Information 7 7
Overheating of Device 7 7
Defective Device 5 5
Sparking 4 4
Electrical Power Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Activation Problem 3 3
Separation Problem 2 2
Unintended Electrical Shock 2 2
Mechanical Problem 2 2
Operating System Becomes Nonfunctional 2 2
Failure to Power Up 2 2
Increase in Pressure 1 1
Material Puncture/Hole 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Arcing of Electrodes 1 1
Defective Component 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Electrical /Electronic Property Problem 1 1
Material Erosion 1 1
Fire 1 1
Image Display Error/Artifact 1 1
Loose or Intermittent Connection 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Suction Failure 1 1
Misassembled During Installation 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
No Patient Involvement 21 21
No Consequences Or Impact To Patient 18 18
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 4 4
Electric Shock 3 3
Bacterial Infection 2 2
Hepatitis 2 2
Hypovolemic Shock 1 1
Perforation 1 1
Sepsis 1 1
Numbness 1 1
Eye Burn 1 1
Burn, Thermal 1 1
Burn(s) 1 1
Hemorrhage/Bleeding 1 1
Abdominal Pain 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Northgate Technologies, Inc. II Jun-03-2022
2 Northgate Technologies, Inc. II Dec-03-2021
3 Northgate Technologies, Inc. II Mar-24-2020
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