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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
2020 232 232
2021 251 251
2022 98 98
2023 72 72
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 249 249
Failure to Form Staple 157 157
Adverse Event Without Identified Device or Use Problem 84 84
Mechanics Altered 62 62
Entrapment of Device 37 37
Activation, Positioning or Separation Problem 29 29
Difficult to Open or Close 26 26
Misfire 21 21
Firing Problem 18 18
Detachment of Device or Device Component 17 17
Patient Device Interaction Problem 17 17
Failure to Fire 15 15
Difficult to Remove 15 15
Break 12 12
Delivered as Unsterile Product 12 12
Failure to Align 10 10
Physical Resistance/Sticking 6 6
Incomplete Coaptation 5 5
Tear, Rip or Hole in Device Packaging 5 5
Material Separation 4 4
Shipping Damage or Problem 4 4
Material Split, Cut or Torn 3 3
Patient-Device Incompatibility 3 3
Device Fell 3 3
Defective Device 3 3
Material Twisted/Bent 2 2
Unintended Ejection 2 2
Contamination /Decontamination Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Component 2 2
Insufficient Information 2 2
Failure to Eject 2 2
Device Slipped 2 2
Leak/Splash 2 2
Component Missing 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Markings/Labelling Problem 1 1
Activation Failure 1 1
Unexpected Therapeutic Results 1 1
Activation Problem 1 1
Separation Problem 1 1
Premature Separation 1 1
Loose or Intermittent Connection 1 1
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 356 356
No Consequences Or Impact To Patient 186 186
Wound Dehiscence 45 45
Insufficient Information 37 37
Pain 36 36
Unspecified Tissue Injury 25 25
Impaired Healing 23 23
Hemorrhage/Bleeding 20 20
Unspecified Infection 14 14
No Known Impact Or Consequence To Patient 10 10
No Patient Involvement 8 8
Skin Disorders 4 4
Post Operative Wound Infection 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Tissue Breakdown 2 2
Unintended Radiation Exposure 2 2
Pneumothorax 1 1
Sepsis 1 1
No Code Available 1 1
No Information 1 1
Purulent Discharge 1 1
Blood Loss 1 1
Intermenstrual Bleeding 1 1
Cellulitis 1 1
Foreign Body Reaction 1 1
Seroma 1 1
Foreign Body In Patient 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Encephalitis 1 1
Failure to Anastomose 1 1
Abscess 1 1
Cerebrospinal Fluid Leakage 1 1
Device Embedded In Tissue or Plaque 1 1

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