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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
CYBERSONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ELMED USA
  SUBSTANTIALLY EQUIVALENT 1
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 2
MED-SONICS CORP
  SUBSTANTIALLY EQUIVALENT 2
MED-SONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 2
WALZ ELEKTRONIK GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 9 9
2015 7 7
2016 7 7
2017 9 9
2018 18 18
2019 10 10
2020 39 39
2021 22 22
2022 13 13
2023 10 10
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 51 51
Output Problem 14 14
No Device Output 11 11
Detachment of Device or Device Component 11 11
Overheating of Device 9 9
Insufficient Information 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Defective Device 5 5
Device Packaging Compromised 5 5
Sparking 4 4
Electrical Power Problem 4 4
Metal Shedding Debris 4 4
Activation Problem 3 3
Detachment Of Device Component 3 3
Device Inoperable 3 3
Therapeutic or Diagnostic Output Failure 3 3
Connection Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
No Apparent Adverse Event 3 3
Operating System Becomes Nonfunctional 2 2
Separation Problem 2 2
Mechanical Problem 2 2
Unintended Electrical Shock 2 2
Loose or Intermittent Connection 2 2
Device Operates Differently Than Expected 2 2
Use of Device Problem 2 2
Failure to Power Up 2 2
Device Contamination with Chemical or Other Material 2 2
Arcing of Electrodes 1 1
Improper or Incorrect Procedure or Method 1 1
Electrical /Electronic Property Problem 1 1
Device Displays Incorrect Message 1 1
Suction Problem 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1
Increase in Pressure 1 1
Device Emits Odor 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Handling Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Gas/Air Leak 1 1
Charred 1 1
Material Discolored 1 1
Material Fragmentation 1 1
Failure To Adhere Or Bond 1 1
Misassembled During Installation 1 1
Difficult to Remove 1 1
Smoking 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 39 39
No Clinical Signs, Symptoms or Conditions 37 37
No Known Impact Or Consequence To Patient 24 24
No Patient Involvement 23 23
No Code Available 5 5
No Information 4 4
Insufficient Information 4 4
Electric Shock 3 3
Burn(s) 3 3
Foreign Body In Patient 2 2
Hepatitis 2 2
Bacterial Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Abdominal Pain 1 1
Hypovolemic Shock 1 1
Death 1 1
Sepsis 1 1
Perforation 1 1
Hematoma 1 1
Burn, Thermal 1 1
Eye Burn 1 1
Numbness 1 1
Hemorrhage/Bleeding 1 1
Internal Organ Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corp II Nov-11-2009
2 Cook Inc. II May-02-2018
3 Northgate Technologies, Inc. II Jun-03-2022
4 Northgate Technologies, Inc. II Dec-03-2021
5 Northgate Technologies, Inc. II Mar-24-2020
6 Northgate Technologies, Inc. II Nov-08-2017
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