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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)
Regulation Description Removable skin staple.
Product CodeGDT
Regulation Number 878.4760
Device Class 1

MDR Year MDR Reports MDR Events
2021 251 251
2022 98 98
2023 72 72
2024 51 51
2025 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 186 186
Mechanics Altered 123 123
Adverse Event Without Identified Device or Use Problem 86 86
Failure to Form Staple 54 54
Entrapment of Device 49 49
Patient Device Interaction Problem 26 26
Firing Problem 25 25
Detachment of Device or Device Component 20 20
Activation, Positioning or Separation Problem 16 16
Failure to Fire 16 16
Difficult to Remove 16 16
Failure to Align 11 11
Break 10 10
Delivered as Unsterile Product 10 10
Misfire 10 10
Difficult to Open or Close 9 9
Tear, Rip or Hole in Device Packaging 5 5
Incomplete Coaptation 5 5
Material Separation 4 4
Physical Resistance/Sticking 4 4
Shipping Damage or Problem 3 3
Defective Device 3 3
Patient-Device Incompatibility 3 3
Failure to Eject 3 3
Material Split, Cut or Torn 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Unintended Ejection 2 2
Insufficient Information 2 2
Therapeutic or Diagnostic Output Failure 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Component Missing 1 1
Defective Component 1 1
Material Twisted/Bent 1 1
Device Markings/Labelling Problem 1 1
Activation Problem 1 1
Activation Failure 1 1
Unexpected Therapeutic Results 1 1
Separation Problem 1 1
Premature Separation 1 1
Device Slipped 1 1
Premature Activation 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 406 406
Wound Dehiscence 47 47
Insufficient Information 43 43
Unspecified Tissue Injury 41 41
Pain 38 38
Impaired Healing 23 23
Hemorrhage/Bleeding 20 20
Unspecified Infection 16 16
Post Operative Wound Infection 9 9
Foreign Body In Patient 5 5
Skin Disorders 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Seroma 3 3
Unintended Radiation Exposure 3 3
Hypersensitivity/Allergic reaction 2 2
Skin Inflammation/ Irritation 2 2
Hematoma 2 2
Itching Sensation 2 2
Rash 2 2
Discomfort 2 2
Abscess 2 2
Tissue Breakdown 2 2
Pneumothorax 1 1
Intraoperative Pain 1 1
Necrosis 1 1
Purulent Discharge 1 1
Intermenstrual Bleeding 1 1
Localized Skin Lesion 1 1
Foreign Body Reaction 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Encephalitis 1 1
Failure to Anastomose 1 1
Cerebrospinal Fluid Leakage 1 1
Device Embedded In Tissue or Plaque 1 1

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