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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

MDR Year MDR Reports MDR Events
2017 9 9
2018 18 18
2019 10 10
2020 39 39
2021 22 22
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 35 35
Output Problem 13 13
No Device Output 11 11
Overheating of Device 9 9
Defective Device 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Packaging Compromised 4 4
Electrical Power Problem 4 4
Detachment of Device or Device Component 3 3
Activation Problem 3 3
Insufficient Information 3 3
Sparking 3 3
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Failure to Power Up 2 2
Separation Problem 2 2
Operating System Becomes Nonfunctional 2 2
Device Contamination with Chemical or Other Material 2 2
Gas Leak 1 1
Material Deformation 1 1
Device Operates Differently Than Expected 1 1
Misassembled During Installation 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Appropriate Term/Code Not Available 1 1
Unintended Electrical Shock 1 1
Suction Failure 1 1
Increase in Pressure 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Device Inoperable 1 1
Suction Problem 1 1
Arcing of Electrodes 1 1
Defective Component 1 1
Device Emits Odor 1 1
Communication or Transmission Problem 1 1
Charred 1 1
Detachment Of Device Component 1 1
Electrical /Electronic Property Problem 1 1
Image Display Error/Artifact 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 28 28
No Patient Involvement 22 22
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 15 15
No Information 4 4
No Code Available 3 3
Insufficient Information 2 2
Electric Shock 2 2
Bacterial Infection 2 2
Burn(s) 2 2
Hepatitis 2 2
Internal Organ Perforation 1 1
Death 1 1
Numbness 1 1
Eye Burn 1 1
Burn, Thermal 1 1
Abdominal Pain 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II May-02-2018
2 Northgate Technologies, Inc. II Dec-03-2021
3 Northgate Technologies, Inc. II Mar-24-2020
4 Northgate Technologies, Inc. II Nov-08-2017
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