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TPLC
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show TPLC since
2009
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2014
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2019
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
2014
37
37
2015
67
67
2016
74
74
2017
101
101
2018
104
104
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
200
200
Detachment Of Device Component
181
181
Retraction Problem
179
179
Break
83
83
Use of Device Problem
60
60
Misfire
41
41
Adverse Event Without Identified Device or Use Problem
31
31
Mechanical Problem
23
23
Device-Device Incompatibility
16
16
Difficult to Open or Close
9
9
Device Operates Differently Than Expected
8
8
Failure to Align
6
6
Material Twisted/Bent
5
5
Tear, Rip or Hole in Device Packaging
4
4
Component Missing
4
4
Material Separation
3
3
Entrapment of Device
3
3
Fracture
3
3
Contamination
3
3
Therapeutic or Diagnostic Output Failure
3
3
Device Or Device Fragments Location Unknown
3
3
Device Contaminated During Manufacture or Shipping
3
3
Device Contamination with Chemical or Other Material
2
2
Appropriate Term/Code Not Available
2
2
Positioning Failure
2
2
Failure To Adhere Or Bond
2
2
Difficult to Insert
2
2
Defective Component
2
2
Improper or Incorrect Procedure or Method
2
2
Other (for use when an appropriate device code cannot be identified)
2
2
Defective Device
2
2
Device Packaging Compromised
2
2
Difficult to Advance
1
1
Unknown (for use when the device problem is not known)
1
1
Solder Joint Fracture
1
1
Bent
1
1
Failure to Capture
1
1
Component Falling
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Device Slipped
1
1
Unsealed Device Packaging
1
1
Difficult to Remove
1
1
Device Handling Problem
1
1
Activation Failure
1
1
Firing Problem
1
1
Device Fell
1
1
Failure of Device to Self-Test
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Packaging Problem
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
223
223
No Clinical Signs, Symptoms or Conditions
167
167
Device Embedded In Tissue or Plaque
132
132
No Known Impact Or Consequence To Patient
120
120
Foreign Body In Patient
44
44
Pain
14
14
Insufficient Information
11
11
No Information
8
8
No Code Available
6
6
No Patient Involvement
6
6
Urinary Retention
4
4
Hemorrhage/Bleeding
4
4
Hematoma
3
3
Vessel Or Plaque, Device Embedded In
2
2
Abscess
1
1
Erosion
1
1
Unspecified Infection
1
1
Nerve Damage
1
1
Tissue Damage
1
1
Constipation
1
1
Dyspareunia
1
1
Unknown (for use when the patient's condition is not known)
1
1
Nonresorbable materials, unretrieved in body
1
1
Discomfort
1
1
Obstruction/Occlusion
1
1
Surgical procedure, additional
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boss Instruments, Ltd.
II
Aug-05-2020
2
Cook Inc.
II
Jun-08-2017
3
Davol, Inc., Sub. C. R. Bard, Inc.
II
Sep-06-2009
4
Dufner Instrumente GmbH
II
Jul-10-2020
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