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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
CYBERSONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
E.M.S ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 1
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 2 2
2017 8 8
2018 9 9
2019 12 12
2020 128 128
2021 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 56 56
Output Problem 48 48
Break 47 47
Defective Component 19 19
Connection Problem 10 10
Material Twisted/Bent 7 7
Activation Problem 6 6
Material Integrity Problem 6 6
No Device Output 5 5
Material Fragmentation 3 3
Fluid Leak 3 3
Failure to Power Up 3 3
Device Damaged Prior to Use 3 3
Leak/Splash 3 3
Electrical Power Problem 2 2
Electrical /Electronic Property Problem 2 2
Power Problem 2 2
Device Fell 2 2
Use of Device Problem 2 2
Metal Shedding Debris 2 2
Fracture 2 2
Loss of Power 2 2
Temperature Problem 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 1 1
Intermittent Loss of Power 1 1
Intermittent Energy Output 1 1
Operating System Becomes Nonfunctional 1 1
Air Leak 1 1
Device Reprocessing Problem 1 1
Suction Problem 1 1
Material Separation 1 1
Sparking 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Incomplete or Inadequate Connection 1 1
Suction Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Flaked 1 1
Insufficient Heating 1 1
Image Display Error/Artifact 1 1
Defective Alarm 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Corroded 1 1
Erratic or Intermittent Display 1 1
Material Deformation 1 1
Device Displays Incorrect Message 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Device Remains Activated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 110 110
No Consequences Or Impact To Patient 54 54
No Clinical Signs, Symptoms or Conditions 20 20
No Known Impact Or Consequence To Patient 18 18
No Code Available 7 7
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Pain 1 1
Injury 1 1
Burn, Thermal 1 1
Insufficient Information 1 1
Numbness 1 1
Inflammation 1 1

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