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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
132
132
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
110
110
Defective Device
60
60
Output Problem
56
56
Communication or Transmission Problem
26
26
Defective Component
22
22
Activation Problem
17
17
Connection Problem
14
14
Power Problem
12
12
No Device Output
10
10
Energy Output Problem
9
9
Failure to Power Up
9
9
Electrical /Electronic Property Problem
9
9
Material Integrity Problem
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Material Twisted/Bent
8
8
Suction Problem
6
6
Crack
6
6
Activation Failure
6
6
Leak/Splash
6
6
Protective Measures Problem
6
6
Device Remains Activated
5
5
Loss of Power
5
5
Fracture
5
5
Material Fragmentation
4
4
Material Separation
4
4
Detachment of Device or Device Component
4
4
Fluid/Blood Leak
4
4
Intermittent Loss of Power
4
4
Device Damaged Prior to Use
3
3
Image Display Error/Artifact
3
3
Failure to Deliver Energy
3
3
Loose or Intermittent Connection
3
3
Corroded
3
3
Use of Device Problem
3
3
Self-Activation or Keying
3
3
Difficult to Remove
3
3
Thermal Decomposition of Device
3
3
Metal Shedding Debris
2
2
Mechanical Problem
2
2
Device Reprocessing Problem
2
2
Flaked
2
2
Delivered as Unsterile Product
2
2
Application Program Problem: Power Calculation Error
2
2
Material Split, Cut or Torn
2
2
Key or Button Unresponsive/not Working
2
2
Temperature Problem
2
2
Device Fell
2
2
Electrical Power Problem
2
2
Insufficient Information
2
2
Suction Failure
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
224
224
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
Patient Problem/Medical Problem
1
1
Pneumothorax
1
1
Sepsis
1
1
Inflammation
1
1
Burn, Thermal
1
1
Burn(s)
1
1
Injury
1
1
Fever
1
1
Numbness
1
1
Pain
1
1
Unspecified Respiratory Problem
1
1
Hemorrhage/Bleeding
1
1
Internal Organ Perforation
1
1
Full thickness (Third Degree) Burn
1
1
Device Embedded In Tissue or Plaque
1
1
Fistula
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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