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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device staple, removable (skin)
Product CodeGDT
Regulation Number 878.4760
Device Class 1

MDR Year MDR Reports MDR Events
2017 657 657
2018 197 197
2019 212 212
2020 231 231
2021 251 251
2022 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 889 889
Failure to Form Staple 303 303
Tear, Rip or Hole in Device Packaging 65 65
Misfire 49 49
Difficult to Open or Close 43 43
Activation, Positioning or SeparationProblem 42 42
Unsealed Device Packaging 33 33
Entrapment of Device 27 27
Failure to Fire 22 22
Premature Activation 20 20
Break 19 19
Failure to Align 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Detachment of Device or Device Component 17 17
Failure to Advance 14 14
Loose or Intermittent Connection 14 14
Delivered as Unsterile Product 10 10
Unintended Movement 10 10
Material Separation 7 7
Device Slipped 7 7
Difficult to Remove 6 6
Mechanics Altered 6 6
Physical Resistance/Sticking 6 6
Device Fell 5 5
Incomplete Coaptation 5 5
Component Missing 4 4
Defective Device 4 4
Firing Problem 4 4
Material Twisted/Bent 3 3
Material Split, Cut or Torn 3 3
Insufficient Information 3 3
Device Dislodged or Dislocated 3 3
Device Damaged Prior to Use 3 3
Shipping Damage or Problem 3 3
Leak/Splash 3 3
Defective Component 2 2
Sticking 2 2
Contamination /Decontamination Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Operates Differently Than Expected 2 2
Packaging Problem 2 2
Patient Device Interaction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Premature Separation 2 2
Activation Problem 1 1
Separation Problem 1 1
Scratched Material 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Device Packaging Compromised 1 1
Material Deformation 1 1
Environmental Particulates 1 1
Patient-Device Incompatibility 1 1
Separation Failure 1 1
Unexpected Therapeutic Results 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Mechanical Problem 1 1
Material Fragmentation 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1
Positioning Failure 1 1
Failure to Discharge 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1052 1052
No Clinical Signs, Symptoms or Conditions 288 288
No Patient Involvement 93 93
No Known Impact Or Consequence To Patient 66 66
Wound Dehiscence 23 23
No Code Available 20 20
No Information 19 19
Insufficient Information 19 19
Not Applicable 13 13
Pain 9 9
Impaired Healing 6 6
Unspecified Infection 6 6
Hematoma 5 5
Skin Disorders 4 4
Injury 4 4
Blood Loss 3 3
Unspecified Tissue Injury 2 2
Hemorrhage/Bleeding 2 2
Abscess 2 2
Cellulitis 1 1
Cerebrospinal Fluid Leakage 1 1
Inflammation 1 1
Reaction 1 1
Encephalitis 1 1
Post Operative Wound Infection 1 1
Organ Dehiscence 1 1
Pneumothorax 1 1
Rash 1 1
Scar Tissue 1 1
Sepsis 1 1
Skin Irritation 1 1
Swelling 1 1
Unintended Radiation Exposure 1 1
Device Embedded In Tissue or Plaque 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Mar-26-2018
2 Teleflex Medical II May-17-2017
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