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TPLC
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Device
lithotriptor, biliary mechanical
Regulation Description
Mechanical lithotriptor.
Product Code
LQC
Regulation Number
876.4500
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
164
164
2021
112
112
2022
245
245
2023
224
224
2024
301
301
2025
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
556
556
Material Split, Cut or Torn
141
141
Material Deformation
138
138
Detachment of Device or Device Component
126
126
Difficult to Open or Close
88
88
Adverse Event Without Identified Device or Use Problem
81
81
Separation Failure
68
68
Use of Device Problem
47
47
Difficult to Remove
32
32
Premature Activation
30
30
Material Twisted/Bent
18
18
Mechanical Problem
18
18
Deformation Due to Compressive Stress
14
14
Crack
11
11
Material Separation
8
8
Mechanical Jam
8
8
Difficult to Advance
7
7
Entrapment of Device
7
7
Appropriate Term/Code Not Available
6
6
Defective Device
6
6
Accessory Incompatible
5
5
Retraction Problem
5
5
Leak/Splash
5
5
Tear, Rip or Hole in Device Packaging
4
4
Defective Component
3
3
Material Integrity Problem
3
3
Device Damaged Prior to Use
2
2
Fracture
2
2
Physical Resistance/Sticking
2
2
Problem with Sterilization
2
2
Device Reprocessing Problem
2
2
Output Problem
1
1
Device-Device Incompatibility
1
1
Failure to Disconnect
1
1
Device Damaged by Another Device
1
1
Material Perforation
1
1
Unintended Movement
1
1
Separation Problem
1
1
Material Too Rigid or Stiff
1
1
Obstruction of Flow
1
1
Product Quality Problem
1
1
Device Dislodged or Dislocated
1
1
Unsealed Device Packaging
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
823
823
No Consequences Or Impact To Patient
129
129
Foreign Body In Patient
31
31
No Code Available
26
26
Hemorrhage/Bleeding
17
17
No Known Impact Or Consequence To Patient
13
13
Perforation
10
10
Insufficient Information
9
9
Device Embedded In Tissue or Plaque
9
9
Pancreatitis
9
9
Abdominal Pain
5
5
Cardiac Arrest
4
4
Unspecified Hepatic or Biliary Problem
4
4
Pneumonia
4
4
Septic Shock
4
4
Fever
2
2
Hypoxia
2
2
Swelling/ Edema
2
2
Patient Problem/Medical Problem
2
2
Pain
2
2
Bradycardia
1
1
Bruise/Contusion
1
1
Death
1
1
Cardiac Enzyme Elevation
1
1
Low Blood Pressure/ Hypotension
1
1
Unspecified Infection
1
1
Inflammation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Pseudoaneurysm
1
1
Intraoperative Pain
1
1
Bowel Perforation
1
1
Myocardial Infarction
1
1
Tissue Damage
1
1
Vomiting
1
1
Peritonitis
1
1
Anxiety
1
1
Discomfort
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aomori Olympus Co., Ltd.
II
Feb-05-2021
2
Olympus Corporation of the Americas
II
Jan-16-2025
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