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TPLC
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show TPLC since
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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
72
72
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
177
177
Retraction Problem
112
112
Use of Device Problem
71
71
Misfire
43
43
Break
26
26
Mechanical Problem
23
23
Adverse Event Without Identified Device or Use Problem
23
23
Device-Device Incompatibility
18
18
Difficult to Open or Close
11
11
Failure to Align
5
5
Material Twisted/Bent
4
4
Defective Device
3
3
Therapeutic or Diagnostic Output Failure
3
3
Contamination
3
3
Material Separation
2
2
Fracture
2
2
Appropriate Term/Code Not Available
2
2
Material Frayed
1
1
Entrapment of Device
1
1
Difficult to Advance
1
1
Device Fell
1
1
Unsealed Device Packaging
1
1
Defective Component
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Positioning Problem
1
1
Difficult to Remove
1
1
Material Fragmentation
1
1
Material Deformation
1
1
Packaging Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Activation Failure
1
1
Suction Problem
1
1
Failure of Device to Self-Test
1
1
Premature Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
200
200
No Consequences Or Impact To Patient
62
62
Foreign Body In Patient
41
41
Device Embedded In Tissue or Plaque
38
38
No Known Impact Or Consequence To Patient
31
31
Insufficient Information
13
13
Pain
4
4
Hemorrhage/Bleeding
4
4
No Code Available
3
3
Hematoma
2
2
No Information
1
1
No Patient Involvement
1
1
Dyspareunia
1
1
Discomfort
1
1
Abscess
1
1
Unspecified Tissue Injury
1
1
Erosion
1
1
Constipation
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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