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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lithotriptor, ultrasonic
Regulation Description Electrohydraulic lithotriptor.
Product CodeFEO
Regulation Number 876.4480
Device Class 2


Premarket Reviews
ManufacturerDecision
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 128 128
2021 66 66
2022 30 30
2023 39 39
2024 221 221
2025 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Break 116 116
Output Problem 63 63
Defective Device 62 62
Communication or Transmission Problem 36 36
Defective Component 22 22
Energy Output Problem 20 20
Connection Problem 19 19
Activation Problem 18 18
Power Problem 16 16
Electrical /Electronic Property Problem 15 15
No Device Output 13 13
Failure to Power Up 12 12
Material Twisted/Bent 9 9
Activation Failure 8 8
Loss of Power 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Leak/Splash 7 7
Crack 7 7
Corroded 7 7
Protective Measures Problem 6 6
Material Deformation 6 6
Loose or Intermittent Connection 5 5
Material Integrity Problem 5 5
Use of Device Problem 5 5
Suction Problem 5 5
Fracture 4 4
Device Remains Activated 4 4
Intermittent Loss of Power 4 4
Fluid/Blood Leak 4 4
Detachment of Device or Device Component 4 4
Image Display Error/Artifact 3 3
Self-Activation or Keying 3 3
Failure to Deliver Energy 3 3
Mechanical Problem 3 3
Device Damaged Prior to Use 3 3
Material Split, Cut or Torn 3 3
Thermal Decomposition of Device 3 3
Complete Loss of Power 3 3
Pressure Problem 2 2
Insufficient Information 2 2
Device Reprocessing Problem 2 2
Application Program Problem: Power Calculation Error 2 2
Device Fell 2 2
Activation, Positioning or Separation Problem 2 2
Sparking 2 2
Flaked 2 2
Incomplete or Inadequate Connection 2 2
Intermittent Energy Output 2 2
Material Fragmentation 2 2
Key or Button Unresponsive/not Working 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 334 334
No Patient Involvement 108 108
No Consequences Or Impact To Patient 51 51
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 4 4
Internal Organ Perforation 1 1
Injury 1 1
Inflammation 1 1
Unspecified Respiratory Problem 1 1
Urinary Tract Infection 1 1
Fistula 1 1
Hemorrhage/Bleeding 1 1
Numbness 1 1
Pain 1 1
Sepsis 1 1
Full thickness (Third Degree) Burn 1 1
Fever 1 1
Pneumothorax 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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