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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
2018 28 28
2019 36 36
2020 59 59
2021 63 63
2022 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 80 80
Break 44 44
Mechanical Jam 21 21
Dull, Blunt 20 20
Difficult to Open or Close 19 19
Use of Device Problem 13 13
Failure to Cut 13 13
Mechanical Problem 10 10
Material Integrity Problem 9 9
Corroded 6 6
Device-Device Incompatibility 5 5
Material Deformation 5 5
Material Twisted/Bent 5 5
Component Missing 5 5
No Apparent Adverse Event 4 4
Appropriate Term/Code Not Available 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Material Separation 3 3
Device Operates Differently Than Expected 3 3
Physical Resistance/Sticking 3 3
Failure to Fire 2 2
Positioning Problem 2 2
Material Split, Cut or Torn 2 2
Defective Device 2 2
Detachment of Device or Device Component 2 2
Premature Activation 2 2
Nonstandard Device 1 1
Structural Problem 1 1
Activation Problem 1 1
No Fail-Safe Mechanism 1 1
Packaging Problem 1 1
Firing Problem 1 1
Sharp Edges 1 1
Material Rupture 1 1
Device Damaged Prior to Use 1 1
Product Quality Problem 1 1
Failure to Read Input Signal 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Fracture 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 148 148
No Consequences Or Impact To Patient 89 89
No Known Impact Or Consequence To Patient 13 13
Not Applicable 7 7
No Code Available 3 3
No Patient Involvement 3 3
No Information 2 2
Hemorrhage/Bleeding 1 1
Hematoma 1 1
Laceration(s) 1 1
Injury 1 1

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