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TPLC
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show TPLC since
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2024
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Device
lithotriptor, ultrasonic
Product Code
FEO
Regulation Number
876.4480
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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