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TPLC
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show TPLC since
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2024
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Device
applier, surgical, clip
Product Code
GDO
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
293
308
2020
221
221
2021
304
304
2022
361
361
2023
368
368
2024
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Form Staple
506
521
Mechanics Altered
286
286
Failure to Align
243
243
Failure to Fire
142
142
Mechanical Problem
96
96
Difficult to Open or Close
88
88
No Apparent Adverse Event
83
83
Break
82
82
Mechanical Jam
72
72
Material Twisted/Bent
66
66
Detachment of Device or Device Component
66
66
Activation, Positioning or Separation Problem
46
46
Appropriate Term/Code Not Available
29
29
Firing Problem
29
29
Adverse Event Without Identified Device or Use Problem
28
28
Insufficient Information
21
21
Entrapment of Device
18
18
Material Integrity Problem
16
16
Device Fell
15
15
Leak/Splash
15
15
Misfire
14
14
Difficult to Remove
12
12
Loose or Intermittent Connection
11
11
Material Separation
9
9
Defective Device
9
9
Physical Resistance/Sticking
9
9
Fail-Safe Problem
8
8
Noise, Audible
7
7
Device Slipped
7
7
Delivered as Unsterile Product
7
7
Patient Device Interaction Problem
6
6
Activation Problem
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Material Deformation
5
5
Difficult to Open or Remove Packaging Material
5
5
Separation Problem
5
5
Positioning Problem
5
5
Therapeutic or Diagnostic Output Failure
5
5
Fracture
5
5
Corroded
4
4
Separation Failure
4
4
Improper or Incorrect Procedure or Method
4
4
Difficult to Insert
3
3
Product Quality Problem
3
3
Unintended Ejection
3
3
Difficult to Fold, Unfold or Collapse
3
3
Device Handling Problem
3
3
Activation Failure
2
2
Unintended Movement
2
2
Difficult or Delayed Separation
2
2
Device Dislodged or Dislocated
2
2
Tear, Rip or Hole in Device Packaging
2
2
Output Problem
2
2
Material Fragmentation
2
2
Peeled/Delaminated
2
2
Failure to Advance
2
2
Dent in Material
1
1
Defective Component
1
1
Failure to Deliver
1
1
Difficult or Delayed Activation
1
1
Device Difficult to Setup or Prepare
1
1
Material Puncture/Hole
1
1
Use of Device Problem
1
1
Retraction Problem
1
1
Unsealed Device Packaging
1
1
Nonstandard Device
1
1
Collapse
1
1
Degraded
1
1
Difficult or Delayed Positioning
1
1
Disconnection
1
1
Material Disintegration
1
1
Display or Visual Feedback Problem
1
1
Packaging Problem
1
1
Material Protrusion/Extrusion
1
1
Malposition of Device
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Migration
1
1
Ejection Problem
1
1
Failure to Eject
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1013
1013
No Consequences Or Impact To Patient
407
422
Hemorrhage/Bleeding
90
90
Insufficient Information
44
44
No Known Impact Or Consequence To Patient
36
36
Unspecified Tissue Injury
19
19
No Information
9
9
Swelling/ Edema
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Perforation of Vessels
7
7
No Code Available
7
7
No Patient Involvement
5
5
Foreign Body In Patient
5
5
Inflammation
5
5
Pain
5
5
Tissue Damage
5
5
Hematoma
4
4
Cardiac Arrest
4
4
Dyspnea
3
3
Blood Loss
3
3
Unintended Radiation Exposure
2
2
Failure to Anastomose
2
2
Laceration(s)
2
2
Nerve Damage
2
2
Hemostasis
1
1
Unspecified Infection
1
1
Pleural Effusion
1
1
Renal Failure
1
1
Wound Dehiscence
1
1
Abdominal Pain
1
1
Abscess
1
1
Adult Respiratory Distress Syndrome
1
1
Exsanguination
1
1
Fever
1
1
Patient Problem/Medical Problem
1
1
Device Embedded In Tissue or Plaque
1
1
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