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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lithotriptor, ultrasonic
Product CodeFEO
Regulation Number 876.4480
Device Class 2


Premarket Reviews
ManufacturerDecision
CYBERSONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
E.M.S ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 1
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 16 16
2015 6 6
2016 2 2
2017 8 8
2018 9 9
2019 12 12
2020 128 128
2021 66 66
2022 30 30
2023 39 39
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Break 83 83
Defective Device 60 60
Output Problem 53 53
Defective Component 20 20
Communication or Transmission Problem 11 11
Connection Problem 10 10
Material Twisted/Bent 8 8
Activation Problem 8 8
Electrical /Electronic Property Problem 8 8
No Device Output 8 8
Failure to Power Up 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Suction Problem 6 6
Material Integrity Problem 6 6
Power Problem 6 6
Loss of Power 5 5
Fracture 5 5
Material Separation 4 4
Leak/Splash 4 4
Device Remains Activated 4 4
Difficult to Remove 3 3
Self-Activation or Keying 3 3
Device Damaged Prior to Use 3 3
Protective Measures Problem 3 3
Fluid/Blood Leak 3 3
Image Display Error/Artifact 3 3
Energy Output Problem 3 3
Material Fragmentation 3 3
Flaked 2 2
Corroded 2 2
Device Reprocessing Problem 2 2
Delivered as Unsterile Product 2 2
Mechanical Problem 2 2
Use of Device Problem 2 2
Metal Shedding Debris 2 2
Application Program Problem: Power Calculation Error 2 2
Temperature Problem 2 2
Insufficient Information 2 2
Intermittent Loss of Power 2 2
Suction Failure 2 2
Device Fell 2 2
Electrical Power Problem 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Operating System Becomes Nonfunctional 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Complete Loss of Power 1 1
Unexpected Shutdown 1 1
Intermittent Energy Output 1 1
Incomplete or Inadequate Connection 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Premature Activation 1 1
Improper or Incorrect Procedure or Method 1 1
Melted 1 1
Misconnection 1 1
Loose or Intermittent Connection 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Contamination 1 1
Intermittent Continuity 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Air Leak 1 1
Defective Alarm 1 1
Crack 1 1
Decrease in Suction 1 1
Erratic or Intermittent Display 1 1
Electromagnetic Interference 1 1
Insufficient Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Patient Involvement 110 110
No Consequences Or Impact To Patient 69 69
No Known Impact Or Consequence To Patient 19 19
No Code Available 12 12
Foreign Body In Patient 3 3
Insufficient Information 2 2
Unspecified Respiratory Problem 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Injury 1 1
Numbness 1 1
Burn, Thermal 1 1
Burn(s) 1 1
Fever 1 1
Fistula 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Internal Organ Perforation 1 1
Pain 1 1
Pneumothorax 1 1
Sepsis 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Aug-11-2022
2 Olympus Corporation of the Americas II Jun-01-2020
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