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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
2017 4 4
2018 27 27
2019 36 36
2020 59 59
2021 63 63
2022 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 59 59
Break 46 46
Dull, Blunt 20 20
Mechanical Jam 20 20
Difficult to Open or Close 17 17
Failure to Cut 13 13
Mechanical Problem 10 10
Use of Device Problem 9 9
Material Integrity Problem 9 9
Corroded 6 6
Material Twisted/Bent 5 5
Device-Device Incompatibility 5 5
Device Operates Differently Than Expected 4 4
Component Missing 4 4
No Apparent Adverse Event 4 4
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 3 3
Material Deformation 3 3
Defective Device 2 2
Failure to Fire 2 2
Detachment of Device or Device Component 2 2
Material Separation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 2 2
Packaging Problem 1 1
Sharp Edges 1 1
Activation Problem 1 1
Inaccurate Information 1 1
Material Split, Cut or Torn 1 1
Firing 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
Device Damaged Prior to Use 1 1
Premature Activation 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Fracture 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Bent 1 1
Structural Problem 1 1
No Fail-Safe Mechanism 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Consequences Or Impact To Patient 89 89
No Known Impact Or Consequence To Patient 17 17
Not Applicable 7 7
No Patient Involvement 3 3
No Code Available 3 3
No Information 1 1
Injury 1 1
Hematoma 1 1
Laceration(s) 1 1

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