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TPLC
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show TPLC since
2008
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2015
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2017
2018
2019
2020
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2023
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Device
passer
Product Code
HWQ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
64
64
2019
55
55
2020
171
171
2021
160
160
2022
63
63
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
282
282
Material Separation
53
53
Mechanical Jam
31
31
Detachment of Device or Device Component
29
29
Mechanical Problem
17
17
Failure to Advance
14
14
Adverse Event Without Identified Device or Use Problem
11
11
Physical Resistance/Sticking
9
9
Detachment Of Device Component
7
7
Fracture
7
7
Material Deformation
6
6
Insufficient Information
6
6
Device Dislodged or Dislocated
5
5
Material Split, Cut or Torn
5
5
Misassembled
5
5
Material Integrity Problem
5
5
Material Fragmentation
5
5
Device Operates Differently Than Expected
5
5
Device Fell
4
4
Delivered as Unsterile Product
4
4
Firing Problem
4
4
Ejection Problem
4
4
Difficult to Open or Close
4
4
No Apparent Adverse Event
4
4
Nonstandard Device
3
3
Device Damaged Prior to Use
3
3
Entrapment of Device
3
3
Failure to Fire
3
3
Device-Device Incompatibility
3
3
Bent
3
3
Positioning Failure
3
3
Separation Failure
2
2
Device Contamination with Chemical or Other Material
2
2
Difficult to Insert
2
2
Activation, Positioning or Separation Problem
2
2
Difficult to Open or Remove Packaging Material
2
2
Separation Problem
2
2
Output Problem
1
1
Appropriate Term/Code Not Available
1
1
Retraction Problem
1
1
Use of Device Problem
1
1
Failure to Align
1
1
Defective Device
1
1
Melted
1
1
Crack
1
1
Loose or Intermittent Connection
1
1
Flaked
1
1
Grounding Malfunction
1
1
Misfire
1
1
Device Disinfection Or Sterilization Issue
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Component Falling
1
1
Difficult to Fold, Unfold or Collapse
1
1
Product Quality Problem
1
1
Solder Joint Fracture
1
1
Unintended Movement
1
1
Problem with Sterilization
1
1
Expiration Date Error
1
1
Failure to Cycle
1
1
Unsealed Device Packaging
1
1
Device Operational Issue
1
1
Installation-Related Problem
1
1
Material Twisted/Bent
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
252
252
No Known Impact Or Consequence To Patient
176
176
No Consequences Or Impact To Patient
36
36
No Information
19
19
Foreign Body In Patient
18
18
No Patient Involvement
9
9
Device Embedded In Tissue or Plaque
6
6
Injury
5
5
Insufficient Information
5
5
Hypersensitivity/Allergic reaction
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Chills
1
1
Tissue Damage
1
1
No Code Available
1
1
Rupture
1
1
Unspecified Infection
1
1
Pain
1
1
Scar Tissue
1
1
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