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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
92
92
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Form Staple
524
539
Mechanics Altered
293
293
Failure to Align
259
259
Failure to Fire
146
146
Mechanical Problem
98
98
Difficult to Open or Close
93
93
Break
86
86
No Apparent Adverse Event
84
84
Mechanical Jam
72
72
Material Twisted/Bent
68
68
Detachment of Device or Device Component
67
67
Activation, Positioning or Separation Problem
46
46
Appropriate Term/Code Not Available
31
31
Adverse Event Without Identified Device or Use Problem
29
29
Firing Problem
29
29
Insufficient Information
23
23
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
Unintended Ejection
12
12
Loose or Intermittent Connection
11
11
Material Separation
9
9
Defective Device
9
9
Physical Resistance/Sticking
9
9
Delivered as Unsterile Product
8
8
Material Deformation
8
8
Fail-Safe Problem
8
8
Noise, Audible
7
7
Device Slipped
7
7
Patient Device Interaction Problem
6
6
Activation Problem
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Difficult to Open or Remove Packaging Material
5
5
Separation Problem
5
5
Positioning Problem
5
5
Therapeutic or Diagnostic Output Failure
5
5
Separation Failure
5
5
Fracture
5
5
Corroded
4
4
Improper or Incorrect Procedure or Method
4
4
Difficult to Insert
3
3
Product Quality Problem
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
Packaging 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
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
1064
1064
No Consequences Or Impact To Patient
407
422
Hemorrhage/Bleeding
92
92
Insufficient Information
45
45
No Known Impact Or Consequence To Patient
36
36
Unspecified Tissue Injury
20
20
No Information
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Swelling/ Edema
8
8
No Code Available
7
7
Perforation of Vessels
7
7
Foreign Body In Patient
6
6
No Patient Involvement
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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