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TPLC
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show TPLC since
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Device
accessories, catheter, g-u
Product Code
KNY
Regulation Number
876.5130
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
19
19
2020
36
36
2021
17
17
2022
19
19
2023
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
49
49
Fracture
14
14
Material Separation
14
14
Device Fell
8
8
Material Fragmentation
5
5
Detachment of Device or Device Component
5
5
Peeled/Delaminated
4
4
Material Twisted/Bent
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Difficult to Remove
1
1
Material Split, Cut or Torn
1
1
Sharp Edges
1
1
Material Frayed
1
1
Problem with Sterilization
1
1
Stretched
1
1
Structural Problem
1
1
Defective Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
36
36
No Consequences Or Impact To Patient
20
20
No Patient Involvement
16
16
No Known Impact Or Consequence To Patient
11
11
Foreign Body In Patient
9
9
Device Embedded In Tissue or Plaque
4
4
Unspecified Kidney or Urinary Problem
3
3
Pulmonary Edema
3
3
Tissue Damage
2
2
Hematuria
2
2
Dysuria
1
1
Injury
1
1
Urinary Tract Infection
1
1
Swelling
1
1
Abrasion
1
1
Fever
1
1
Myocardial Infarction
1
1
Pain
1
1
Perforation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Olympus Corporation of the Americas
II
Aug-14-2023
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