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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
2020 232 234
2021 251 251
2022 98 98
2023 72 72
2024 51 51
2025 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 251 251
Failure to Form Staple 160 160
Mechanics Altered 111 111
Adverse Event Without Identified Device or Use Problem 89 89
Entrapment of Device 50 50
Activation, Positioning or Separation Problem 29 29
Firing Problem 26 26
Difficult to Open or Close 26 26
Patient Device Interaction Problem 24 24
Detachment of Device or Device Component 23 23
Failure to Fire 22 23
Misfire 22 22
Difficult to Remove 15 15
Break 13 13
Failure to Align 12 12
Delivered as Unsterile Product 12 12
Physical Resistance/Sticking 6 6
Material Separation 6 6
Defective Device 5 5
Tear, Rip or Hole in Device Packaging 5 5
Incomplete Coaptation 5 5
Shipping Damage or Problem 4 4
Device Fell 3 3
Patient-Device Incompatibility 3 3
Failure to Eject 3 3
Material Split, Cut or Torn 3 3
Defective Component 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Contamination /Decontamination Problem 2 2
Unintended Ejection 2 2
Material Twisted/Bent 2 2
Device Slipped 2 3
Leak/Splash 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Markings/Labelling Problem 1 1
Material Fragmentation 1 1
Component Missing 1 1
Activation Problem 1 1
Activation Failure 1 1
Separation Problem 1 1
Unexpected Therapeutic Results 1 1
Premature Separation 1 1
Loose or Intermittent Connection 1 2
Failure to Discharge 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 411 411
No Consequences Or Impact To Patient 186 186
Wound Dehiscence 47 47
Insufficient Information 45 45
Unspecified Tissue Injury 40 40
Pain 39 39
Impaired Healing 23 23
Hemorrhage/Bleeding 20 20
Unspecified Infection 17 17
No Known Impact Or Consequence To Patient 10 12
Post Operative Wound Infection 9 9
No Patient Involvement 8 8
Skin Disorders 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unintended Radiation Exposure 3 3
Hematoma 3 3
Foreign Body In Patient 3 3
Seroma 3 3
Tissue Breakdown 2 2
Abscess 2 2
Discomfort 2 2
Rash 2 2
Itching Sensation 2 2
Skin Inflammation/ Irritation 2 2
Hypersensitivity/Allergic reaction 2 2
Foreign Body Reaction 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Intermenstrual Bleeding 1 1
Blood Loss 1 1
Necrosis 1 1
Encephalitis 1 1
Scar Tissue 1 1
Laceration(s) 1 1
No Information 1 1
Failure to Anastomose 1 1
Sepsis 1 1
Cerebrospinal Fluid Leakage 1 1
No Code Available 1 1
Intraoperative Pain 1 1
Pneumothorax 1 1
Device Embedded In Tissue or Plaque 1 1

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