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TPLC
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show TPLC since
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Device
staple, removable (skin)
Product Code
GDT
Regulation Number
878.4760
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
197
197
2019
212
212
2020
232
232
2021
251
251
2022
98
98
2023
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Jam
473
473
Failure to Form Staple
222
222
Activation, Positioning or Separation Problem
39
39
Adverse Event Without Identified Device or Use Problem
39
39
Misfire
34
34
Mechanics Altered
33
33
Difficult to Open or Close
32
32
Entrapment of Device
27
27
Detachment of Device or Device Component
20
20
Break
19
19
Failure to Fire
18
18
Failure to Advance
14
14
Failure to Align
13
13
Delivered as Unsterile Product
11
11
Unintended Movement
10
10
Firing Problem
9
9
Device Slipped
9
9
Patient Device Interaction Problem
7
7
Physical Resistance/Sticking
6
6
Tear, Rip or Hole in Device Packaging
6
6
Incomplete Coaptation
5
5
Component Missing
5
5
Defective Device
5
5
Material Separation
5
5
Device Fell
5
5
Insufficient Information
4
4
Shipping Damage or Problem
4
4
Premature Activation
4
4
Difficult to Remove
4
4
Leak/Splash
3
3
Patient-Device Incompatibility
3
3
Defective Component
3
3
Material Split, Cut or Torn
3
3
Material Twisted/Bent
3
3
Therapeutic or Diagnostic Output Failure
2
2
Failure to Eject
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Premature Separation
2
2
Contamination /Decontamination Problem
2
2
Loose or Intermittent Connection
2
2
Unintended Ejection
2
2
Material Fragmentation
1
1
Mechanical Problem
1
1
Device Reprocessing Problem
1
1
Detachment Of Device Component
1
1
Failure to Discharge
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Unsealed Device Packaging
1
1
Unexpected Therapeutic Results
1
1
Device Damaged Prior to Use
1
1
Device Markings/Labelling Problem
1
1
Device Operates Differently Than Expected
1
1
Separation Failure
1
1
Activation Problem
1
1
Separation Problem
1
1
Material Deformation
1
1
Device Dislodged or Dislocated
1
1
Packaging Problem
1
1
Scratched Material
1
1
Appropriate Term/Code Not Available
1
1
Activation Failure
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
533
533
No Clinical Signs, Symptoms or Conditions
315
315
Wound Dehiscence
47
47
No Known Impact Or Consequence To Patient
34
34
Insufficient Information
27
27
Pain
22
22
Hemorrhage/Bleeding
20
20
Impaired Healing
20
20
No Code Available
16
16
No Information
14
14
No Patient Involvement
12
12
Unspecified Infection
9
9
Hematoma
6
6
Unspecified Tissue Injury
5
5
Skin Disorders
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Blood Loss
3
3
Skin Inflammation/ Irritation
2
2
Unintended Radiation Exposure
2
2
Post Operative Wound Infection
2
2
Scar Tissue
1
1
Sepsis
1
1
Failure to Anastomose
1
1
Inflammation
1
1
Swelling
1
1
Cellulitis
1
1
Foreign Body Reaction
1
1
Foreign Body In Patient
1
1
Not Applicable
1
1
Seroma
1
1
Hypersensitivity/Allergic reaction
1
1
Intermenstrual Bleeding
1
1
Device Embedded In Tissue or Plaque
1
1
Itching Sensation
1
1
Pneumothorax
1
1
Injury
1
1
Encephalitis
1
1
Purulent Discharge
1
1
Abscess
1
1
Cerebrospinal Fluid Leakage
1
1
Rash
1
1
Skin Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Teleflex Medical
II
Mar-26-2018
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