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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
2018 197 197
2019 212 212
2020 232 232
2021 251 251
2022 98 98
2023 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Jam 473 473
Failure to Form Staple 222 222
Activation, Positioning or Separation Problem 39 39
Adverse Event Without Identified Device or Use Problem 39 39
Misfire 34 34
Mechanics Altered 33 33
Difficult to Open or Close 32 32
Entrapment of Device 27 27
Detachment of Device or Device Component 20 20
Break 19 19
Failure to Fire 18 18
Failure to Advance 14 14
Failure to Align 13 13
Delivered as Unsterile Product 11 11
Unintended Movement 10 10
Firing Problem 9 9
Device Slipped 9 9
Patient Device Interaction Problem 7 7
Physical Resistance/Sticking 6 6
Tear, Rip or Hole in Device Packaging 6 6
Incomplete Coaptation 5 5
Component Missing 5 5
Defective Device 5 5
Material Separation 5 5
Device Fell 5 5
Insufficient Information 4 4
Shipping Damage or Problem 4 4
Premature Activation 4 4
Difficult to Remove 4 4
Leak/Splash 3 3
Patient-Device Incompatibility 3 3
Defective Component 3 3
Material Split, Cut or Torn 3 3
Material Twisted/Bent 3 3
Therapeutic or Diagnostic Output Failure 2 2
Failure to Eject 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Premature Separation 2 2
Contamination /Decontamination Problem 2 2
Loose or Intermittent Connection 2 2
Unintended Ejection 2 2
Material Fragmentation 1 1
Mechanical Problem 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1
Failure to Discharge 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unsealed Device Packaging 1 1
Unexpected Therapeutic Results 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Separation Failure 1 1
Activation Problem 1 1
Separation Problem 1 1
Material Deformation 1 1
Device Dislodged or Dislocated 1 1
Packaging Problem 1 1
Scratched Material 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 533 533
No Clinical Signs, Symptoms or Conditions 315 315
Wound Dehiscence 47 47
No Known Impact Or Consequence To Patient 34 34
Insufficient Information 27 27
Pain 22 22
Hemorrhage/Bleeding 20 20
Impaired Healing 20 20
No Code Available 16 16
No Information 14 14
No Patient Involvement 12 12
Unspecified Infection 9 9
Hematoma 6 6
Unspecified Tissue Injury 5 5
Skin Disorders 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blood Loss 3 3
Skin Inflammation/ Irritation 2 2
Unintended Radiation Exposure 2 2
Post Operative Wound Infection 2 2
Scar Tissue 1 1
Sepsis 1 1
Failure to Anastomose 1 1
Inflammation 1 1
Swelling 1 1
Cellulitis 1 1
Foreign Body Reaction 1 1
Foreign Body In Patient 1 1
Not Applicable 1 1
Seroma 1 1
Hypersensitivity/Allergic reaction 1 1
Intermenstrual Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1
Itching Sensation 1 1
Pneumothorax 1 1
Injury 1 1
Encephalitis 1 1
Purulent Discharge 1 1
Abscess 1 1
Cerebrospinal Fluid Leakage 1 1
Rash 1 1
Skin Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical II Mar-26-2018
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