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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
2021 63 63
2022 76 76
2023 58 58
2024 84 84
2025 57 57
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 191 191
Mechanical Jam 60 60
Difficult to Open or Close 44 44
Use of Device Problem 37 37
Break 21 21
Material Deformation 19 19
Material Integrity Problem 10 10
Device-Device Incompatibility 8 8
Mechanical Problem 6 6
Appropriate Term/Code Not Available 5 5
Dull, Blunt 5 5
No Apparent Adverse Event 3 3
Defective Device 2 2
Component Missing 2 2
Detachment of Device or Device Component 2 2
Premature Activation 2 2
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Difficult to Advance 1 1
Difficult to Remove 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Sharp Edges 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Firing Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 335 335
Foreign Body In Patient 2 2
Laceration(s) 1 1
Perforation of Vessels 1 1
No Consequences Or Impact To Patient 1 1
Hemorrhage/Bleeding 1 1

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