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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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 69 69
Positioning Failure 14 14
Material Deformation 8 8
Firing Problem 8 8
Break 8 8
Mechanical Jam 4 4
Premature Activation 3 3
Loose or Intermittent Connection 3 3
Activation, Positioning or Separation Problem 3 3
Use of Device Problem 2 2
Misfire 2 2
Material Twisted/Bent 2 2
Device Damaged Prior to Use 2 2
Physical Resistance/Sticking 2 2
Device Contaminated During Manufacture or Shipping 1 1
Unintended Movement 1 1
Material Separation 1 1
Entrapment of Device 1 1
Detachment of Device or Device Component 1 1
Fracture 1 1
Compatibility Problem 1 1
Failure to Advance 1 1
Melted 1 1
Appropriate Term/Code Not Available 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 64 64
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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