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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,
Product CodeGEF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 14 14
2018 74 74
2019 41 41
2020 19 19
2021 20 20
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 46 46
Positioning Failure 43 43
Activation, Positioning or SeparationProblem 26 26
Mechanical Jam 12 12
Break 10 10
Firing Problem 8 8
Material Deformation 5 5
Failure to Fire 5 5
Mechanical Problem 4 4
Activation Problem 4 4
Material Twisted/Bent 3 3
Misfire 3 3
Loose or Intermittent Connection 3 3
Device Damaged Prior to Use 2 2
Deformation Due to Compressive Stress 2 2
Physical Resistance/Sticking 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Difficult to Open or Close 2 2
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Connection Problem 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Failure to Advance 1 1
Loss of or Failure to Bond 1 1
Melted 1 1
Delivered as Unsterile Product 1 1
Premature Activation 1 1
Material Separation 1 1
Detachment Of Device Component 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 119 119
No Clinical Signs, Symptoms or Conditions 27 27
Not Applicable 15 15
No Code Available 12 12
No Known Impact Or Consequence To Patient 12 12
Tissue Damage 7 7
Injury 5 5
Foreign Body In Patient 2 2
Laceration(s) 1 1
Device Embedded In Tissue or Plaque 1 1

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