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TPLC
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Device
lithotriptor, ultrasonic
Regulation Description
Electrohydraulic lithotriptor.
Product Code
FEO
Regulation Number
876.4480
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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