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TPLC
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Device
holder, needle, gastroenterologic
Regulation Description
Manual gastroenterology-urology surgical instrument and accessories.
Product Code
FHQ
Regulation Number
876.4730
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
50
50
2021
57
57
2022
64
64
2023
63
63
2024
71
71
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
122
122
Retraction Problem
91
91
Use of Device Problem
71
71
Misfire
40
40
Adverse Event Without Identified Device or Use Problem
23
23
Break
21
21
Mechanical Problem
20
20
Device-Device Incompatibility
14
14
Difficult to Open or Close
10
10
Failure to Align
5
5
Contamination
3
3
Defective Device
3
3
Therapeutic or Diagnostic Output Failure
3
3
Material Twisted/Bent
2
2
Appropriate Term/Code Not Available
2
2
Material Separation
2
2
Material Frayed
1
1
Device Fell
1
1
Suction Problem
1
1
Material Fragmentation
1
1
Positioning Problem
1
1
Defective Component
1
1
Packaging Problem
1
1
Fracture
1
1
Premature Separation
1
1
Material Deformation
1
1
Difficult to Advance
1
1
Unsealed Device Packaging
1
1
Activation Failure
1
1
Tear, Rip or Hole in Device Packaging
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Failure of Device to Self-Test
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
203
203
Foreign Body In Patient
37
37
No Consequences Or Impact To Patient
23
23
No Known Impact Or Consequence To Patient
17
17
Device Embedded In Tissue or Plaque
14
14
Insufficient Information
13
13
Hemorrhage/Bleeding
4
4
Pain
2
2
Hematoma
2
2
Abscess
1
1
Constipation
1
1
No Patient Involvement
1
1
Erosion
1
1
Dyspareunia
1
1
Unspecified Tissue Injury
1
1
Discomfort
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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