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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
2017
40
40
2018
60
60
2019
28
28
2020
28
28
2021
32
32
2022
35
35
2023
18
18
2024
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
67
67
Mechanical Jam
34
34
Corroded
22
22
Failure to Cut
16
16
Physical Resistance/Sticking
15
15
Mechanical Problem
13
13
Difficult to Open or Close
13
13
Adverse Event Without Identified Device or Use Problem
11
11
Misfire
11
11
Detachment of Device or Device Component
11
11
Material Fragmentation
7
7
Entrapment of Device
6
6
Insufficient Information
6
6
Contamination /Decontamination Problem
6
6
Material Separation
6
6
Fracture
6
6
Delivered as Unsterile Product
6
6
Device Operates Differently Than Expected
5
5
Difficult to Remove
5
5
Component Missing
4
4
Detachment Of Device Component
4
4
Improper or Incorrect Procedure or Method
3
3
Packaging Problem
3
3
Activation, Positioning or Separation Problem
3
3
Material Too Rigid or Stiff
2
2
Sticking
2
2
No Apparent Adverse Event
2
2
Material Integrity Problem
2
2
Leak/Splash
2
2
Failure to Disconnect
1
1
Loose or Intermittent Connection
1
1
No Pressure
1
1
Scratched Material
1
1
Positioning Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Physical Property Issue
1
1
Device Markings/Labelling Problem
1
1
Crack
1
1
Material Frayed
1
1
Material Deformation
1
1
Pitted
1
1
Dull, Blunt
1
1
Noise, Audible
1
1
Structural Problem
1
1
Out-Of-Box Failure
1
1
Mechanics Altered
1
1
Material Perforation
1
1
Use of Device Problem
1
1
Separation Failure
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
88
88
No Consequences Or Impact To Patient
65
65
No Known Impact Or Consequence To Patient
31
31
No Patient Involvement
29
29
Insufficient Information
18
18
No Information
14
14
Tissue Damage
14
14
Foreign Body In Patient
11
11
Not Applicable
4
4
Laceration(s)
4
4
Unspecified Tissue Injury
4
4
Device Embedded In Tissue or Plaque
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Vascular Dissection
3
3
Perforation of Vessels
3
4
Cardiac Perforation
2
2
Death
1
1
Perforation
1
1
Blood Loss
1
1
Cardiac Tamponade
1
1
Unspecified Vascular Problem
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
Genesee BioMedical, Inc.
II
May-29-2018
4
Maquet Cardiovascular, LLC
II
Jul-31-2023
5
Maquet Cardiovascular, LLC
II
Apr-12-2022
6
TELEFLEX MEDICAL INC
II
Jan-27-2020
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