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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
2019 212 212
2020 232 232
2021 251 251
2022 98 98
2023 72 72
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 353 353
Failure to Form Staple 195 195
Adverse Event Without Identified Device or Use Problem 79 79
Mechanics Altered 52 52
Activation, Positioning or Separation Problem 38 38
Entrapment of Device 37 37
Difficult to Open or Close 28 28
Misfire 27 27
Failure to Fire 20 20
Detachment of Device or Device Component 19 19
Patient Device Interaction Problem 17 17
Firing Problem 16 16
Break 16 16
Failure to Advance 14 14
Delivered as Unsterile Product 12 12
Difficult to Remove 12 12
Failure to Align 11 11
Unintended Movement 9 9
Tear, Rip or Hole in Device Packaging 7 7
Physical Resistance/Sticking 6 6
Device Fell 5 5
Insufficient Information 5 5
Incomplete Coaptation 5 5
Defective Device 5 5
Material Separation 5 5
Shipping Damage or Problem 4 4
Device Slipped 3 3
Defective Component 3 3
Leak/Splash 3 3
Material Twisted/Bent 3 3
Material Split, Cut or Torn 3 3
Failure to Eject 2 2
Therapeutic or Diagnostic Output Failure 2 2
Loose or Intermittent Connection 2 2
Premature Activation 2 2
Unintended Ejection 2 2
Patient-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Material Fragmentation 1 1
Failure to Discharge 1 1
Mechanical Problem 1 1
Component Missing 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unexpected Therapeutic Results 1 1
Scratched Material 1 1
Activation Failure 1 1
Noise, Audible 1 1
Activation Problem 1 1
Separation Problem 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 366 366
No Clinical Signs, Symptoms or Conditions 345 345
Wound Dehiscence 49 49
Insufficient Information 34 34
Pain 31 31
Impaired Healing 22 22
No Known Impact Or Consequence To Patient 22 22
Unspecified Tissue Injury 22 22
Hemorrhage/Bleeding 20 20
Unspecified Infection 15 15
No Information 11 11
No Patient Involvement 10 10
Hematoma 6 6
No Code Available 4 4
Skin Disorders 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unintended Radiation Exposure 2 2
Skin Inflammation/ Irritation 2 2
Device Embedded In Tissue or Plaque 2 2
Post Operative Wound Infection 2 2
Blood Loss 2 2
Discomfort 2 2
Encephalitis 1 1
Intermenstrual Bleeding 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Not Applicable 1 1
Failure to Anastomose 1 1
Hypersensitivity/Allergic reaction 1 1
Abscess 1 1
Cellulitis 1 1
Cerebrospinal Fluid Leakage 1 1
Purulent Discharge 1 1
Foreign Body Reaction 1 1
Inflammation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Pneumothorax 1 1
Rash 1 1
Scar Tissue 1 1
Sepsis 1 1
Seroma 1 1
Swelling 1 1

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