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TPLC
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show TPLC since
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2020
2021
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2024
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Device
holder, needle, gastroenterologic
Product Code
FHQ
Regulation Number
876.4730
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
80
80
2020
50
50
2021
57
57
2022
64
64
2023
63
63
2024
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
164
164
Retraction Problem
110
110
Use of Device Problem
58
58
Misfire
31
31
Break
26
26
Mechanical Problem
22
22
Adverse Event Without Identified Device or Use Problem
18
18
Device-Device Incompatibility
16
16
Difficult to Open or Close
9
9
Failure to Align
4
4
Material Twisted/Bent
4
4
Therapeutic or Diagnostic Output Failure
3
3
Contamination
3
3
Fracture
2
2
Material Separation
2
2
Defective Device
2
2
Defective Component
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure of Device to Self-Test
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Unsealed Device Packaging
1
1
Difficult to Remove
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Entrapment of Device
1
1
Appropriate Term/Code Not Available
1
1
Activation Failure
1
1
Device Fell
1
1
Difficult to Advance
1
1
Packaging Problem
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
167
167
No Consequences Or Impact To Patient
62
62
Device Embedded In Tissue or Plaque
38
38
Foreign Body In Patient
37
37
No Known Impact Or Consequence To Patient
31
31
Insufficient Information
11
11
Hemorrhage/Bleeding
4
4
Pain
4
4
No Code Available
3
3
Hematoma
2
2
Constipation
1
1
Dyspareunia
1
1
No Information
1
1
Abscess
1
1
Erosion
1
1
Discomfort
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boss Instruments, Ltd.
II
Aug-05-2020
2
Dufner Instrumente GmbH
II
Jul-10-2020
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