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TPLC
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show TPLC since
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Device
instruments, surgical, cardiovascular
Product Code
DWS
Regulation Number
870.4500
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
28
28
2020
28
28
2021
32
32
2022
35
35
2023
18
18
2024
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
43
43
Corroded
20
20
Mechanical Jam
13
13
Physical Resistance/Sticking
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Failure to Cut
8
8
Detachment of Device or Device Component
8
8
Mechanical Problem
7
7
Material Fragmentation
6
6
Insufficient Information
6
6
Material Separation
4
4
Improper or Incorrect Procedure or Method
3
3
Component Missing
3
3
Entrapment of Device
3
3
Fracture
3
3
Difficult to Open or Close
3
3
Packaging Problem
2
2
Leak/Splash
2
2
Misfire
2
2
Difficult to Remove
2
2
Material Too Rigid or Stiff
1
1
Material Perforation
1
1
Failure to Disconnect
1
1
Separation Failure
1
1
Loose or Intermittent Connection
1
1
Pitted
1
1
Material Erosion
1
1
Crack
1
1
Mechanics Altered
1
1
Material Integrity Problem
1
1
Device Markings/Labelling Problem
1
1
Noise, Audible
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
82
82
No Consequences Or Impact To Patient
18
18
No Patient Involvement
18
18
Insufficient Information
15
15
No Information
10
10
No Known Impact Or Consequence To Patient
8
8
Tissue Damage
8
8
Foreign Body In Patient
7
7
Unspecified Tissue Injury
4
4
Vascular Dissection
3
3
Perforation of Vessels
3
4
Cardiac Perforation
2
2
Laceration(s)
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Unspecified Vascular Problem
1
1
Blood Loss
1
1
Cardiac Tamponade
1
1
Death
1
1
Low Blood Pressure/ Hypotension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Vandergrift, Inc.
II
Sep-01-2023
2
Deroyal Industries, Inc. Lafollette
II
Feb-19-2020
3
Maquet Cardiovascular, LLC
II
Jul-31-2023
4
Maquet Cardiovascular, LLC
II
Apr-12-2022
5
TELEFLEX MEDICAL INC
II
Jan-27-2020
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