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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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 64 64
Positioning Failure 14 14
Material Deformation 8 8
Firing Problem 8 8
Break 8 8
Mechanical Jam 4 4
Loose or Intermittent Connection 3 3
Premature Activation 3 3
Activation, Positioning or Separation Problem 3 3
Misfire 2 2
Use of Device Problem 2 2
Device Damaged Prior to Use 2 2
Material Twisted/Bent 2 2
Physical Resistance/Sticking 2 2
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Failure to Advance 1 1
Material Separation 1 1
Melted 1 1
Entrapment of Device 1 1
Fracture 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Consequences Or Impact To Patient 46 46
No Code Available 11 11
Not Applicable 7 7
Injury 5 5
Tissue Damage 4 4
Laceration(s) 1 1
Insufficient Information 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1

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