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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applier, staple, surgical,
Product CodeGEF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 41 41
2020 19 19
2021 20 20
2022 18 18
2023 18 18
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 88 88
Positioning Failure 14 14
Material Deformation 10 10
Premature Activation 9 9
Break 8 8
Firing Problem 8 8
Mechanical Jam 4 4
Activation, Positioning or Separation Problem 3 3
Loose or Intermittent Connection 3 3
Physical Resistance/Sticking 2 2
Device Damaged Prior to Use 2 2
Unintended Movement 2 2
Misfire 2 2
Use of Device Problem 2 2
Material Twisted/Bent 2 2
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Entrapment of Device 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Fracture 1 1
Failure to Advance 1 1
Appropriate Term/Code Not Available 1 1
Melted 1 1
Difficult to Open or Close 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 90 90
No Consequences Or Impact To Patient 46 46
No Code Available 11 11
Not Applicable 7 7
Injury 5 5
Tissue Damage 4 4
No Known Impact Or Consequence To Patient 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Laceration(s) 1 1

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