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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cutter, surgical
Product CodeFZT
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 36 36
2020 59 59
2021 63 63
2022 76 76
2023 60 60
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 125 125
Break 39 39
Mechanical Jam 37 37
Difficult to Open or Close 27 27
Use of Device Problem 26 26
Dull, Blunt 21 21
Material Deformation 15 15
Failure to Cut 12 12
Material Integrity Problem 10 10
Mechanical Problem 9 9
Device-Device Incompatibility 9 9
Corroded 6 6
Material Twisted/Bent 5 5
Component Missing 5 5
No Apparent Adverse Event 4 4
Appropriate Term/Code Not Available 2 2
Material Split, Cut or Torn 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Defective Device 2 2
Failure to Fire 2 2
Premature Activation 2 2
Product Quality Problem 1 1
Material Rupture 1 1
Material Separation 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Detachment of Device or Device Component 1 1
Packaging Problem 1 1
Positioning Problem 1 1
No Fail-Safe Mechanism 1 1
Firing Problem 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Activation Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 228 228
No Consequences Or Impact To Patient 75 75
Not Applicable 7 7
No Patient Involvement 3 3
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1

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