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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
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
80
80
Defective Device
60
60
Output Problem
53
53
Defective Component
20
20
Communication or Transmission Problem
10
10
Connection Problem
10
10
Material Twisted/Bent
8
8
No Device Output
8
8
Failure to Power Up
7
7
Electrical /Electronic Property Problem
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Activation Problem
7
7
Material Integrity Problem
6
6
Suction Problem
6
6
Power Problem
6
6
Fracture
5
5
Device Remains Activated
4
4
Material Separation
4
4
Leak/Splash
4
4
Difficult to Remove
3
3
Self-Activation or Keying
3
3
Material Fragmentation
3
3
Fluid/Blood Leak
3
3
Image Display Error/Artifact
3
3
Device Damaged Prior to Use
3
3
Loss of Power
3
3
Detachment of Device or Device Component
2
2
Protective Measures Problem
2
2
Temperature Problem
2
2
Insufficient Information
2
2
Electrical Power Problem
2
2
Suction Failure
2
2
Device Fell
2
2
Flaked
2
2
Corroded
2
2
Device Reprocessing Problem
2
2
Use of Device Problem
2
2
Metal Shedding Debris
2
2
Mechanical Problem
2
2
Delivered as Unsterile Product
2
2
Energy Output Problem
1
1
Application Program Problem: Power Calculation Error
1
1
Melted
1
1
Misconnection
1
1
Loose or Intermittent Connection
1
1
Improper or Incorrect Procedure or Method
1
1
Premature Activation
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
Decrease in Suction
1
1
Erratic or Intermittent Display
1
1
Insufficient Heating
1
1
Complete Loss of Power
1
1
Intermittent Loss of Power
1
1
Unexpected Shutdown
1
1
Intermittent Energy Output
1
1
Incomplete or Inadequate Connection
1
1
Operating System Becomes Nonfunctional
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Device Displays Incorrect Message
1
1
Sparking
1
1
Activation Failure
1
1
Material Split, Cut or Torn
1
1
Device Operates Differently Than Expected
1
1
Device Damaged by Another Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
110
110
No Clinical Signs, Symptoms or Conditions
105
105
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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