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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cutter, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeFZT
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 59 59
2021 63 63
2022 76 76
2023 60 60
2024 84 84
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 172 172
Mechanical Jam 58 58
Difficult to Open or Close 41 41
Use of Device Problem 36 36
Break 27 27
Dull, Blunt 24 24
Material Deformation 19 19
Material Integrity Problem 11 11
Device-Device Incompatibility 9 9
Mechanical Problem 9 9
Corroded 6 6
Component Missing 5 5
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 3 3
Defective Device 2 2
Material Twisted/Bent 2 2
Failure to Cut 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Failure to Fire 2 2
Premature Activation 2 2
Fitting Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Device Damaged Prior to Use 1 1
Difficult to Advance 1 1
No Fail-Safe Mechanism 1 1
Sharp Edges 1 1
Material Rupture 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 308 308
No Consequences Or Impact To Patient 47 47
Not Applicable 3 3
Foreign Body In Patient 2 2
Hematoma 1 1
No Known Impact Or Consequence To Patient 1 1
Laceration(s) 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sklar Instruments II Jan-16-2025
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