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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device knife, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeEMF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 4 126
2022 10 132
2023 3 3
2024 1 1
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10 132
Use of Device Problem 3 3
Material Fragmentation 3 3
Detachment of Device or Device Component 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Component Missing 1 1
Fluid/Blood Leak 1 1
Material Protrusion/Extrusion 1 1
Positioning Problem 1 123
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 132
Foreign Body In Patient 4 126
Insufficient Information 4 4
Laceration(s) 2 2
Damage to Ligament(s) 1 1
Abrasion 1 1
Numbness 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MicroAire Surgical Instruments, LLC II Jun-12-2025
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