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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device applier, staple, surgical,
Regulation Description Manual surgical instrument for general use.
Product CodeGEF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 19 19
2021 20 20
2022 18 18
2023 18 18
2024 44 44
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 94 94
Premature Activation 10 10
Material Deformation 9 9
Break 6 6
Loose or Intermittent Connection 3 3
Positioning Failure 2 2
Use of Device Problem 2 2
Unintended Movement 2 2
Misfire 2 2
Appropriate Term/Code Not Available 2 2
Device Damaged Prior to Use 2 2
Mechanical Jam 1 1
Deformation Due to Compressive Stress 1 1
Compatibility Problem 1 1
Entrapment of Device 1 1
Material Twisted/Bent 1 1
Activation, Positioning or Separation Problem 1 1
Physical Resistance/Sticking 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 105 105
No Consequences Or Impact To Patient 13 13
Tissue Damage 3 3
No Code Available 3 3
Laceration(s) 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1

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