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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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 38 38
Output Problem 14 14
No Device Output 11 11
Overheating of Device 9 9
Defective Device 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 4 4
Detachment of Device or Device Component 4 4
Device Packaging Compromised 4 4
Electrical Power Problem 4 4
Sparking 4 4
Activation Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Separation Problem 2 2
Failure to Power Up 2 2
Device Contamination with Chemical or Other Material 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Operating System Becomes Nonfunctional 2 2
Packaging Problem 1 1
Appropriate Term/Code Not Available 1 1
Unintended Electrical Shock 1 1
Suction Failure 1 1
Device Emits Odor 1 1
Device Operates Differently Than Expected 1 1
Gas Leak 1 1
Material Deformation 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
Communication or Transmission Problem 1 1
Connection Problem 1 1
Charred 1 1
Detachment Of Device Component 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Image Display Error/Artifact 1 1
Leak/Splash 1 1
Misassembled During Installation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 28 28
No Clinical Signs, Symptoms or Conditions 24 24
No Patient Involvement 22 22
No Known Impact Or Consequence To Patient 15 15
No Information 4 4
No Code Available 3 3
Insufficient Information 3 3
Electric Shock 2 2
Bacterial Infection 2 2
Burn(s) 2 2
Hepatitis 2 2
Internal Organ Perforation 1 1
Sepsis 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 Jun-03-2022
3 Northgate Technologies, Inc. II Dec-03-2021
4 Northgate Technologies, Inc. II Mar-24-2020
5 Northgate Technologies, Inc. II Nov-08-2017
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