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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2020 4 4
2021 4 4
2022 5 5
2023 10 10
2024 15 15
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 18 18
Device-Device Incompatibility 5 5
Unsealed Device Packaging 4 4
Unintended Ejection 3 3
Retraction Problem 2 2
Detachment of Device or Device Component 2 2
No Apparent Adverse Event 2 2
Unintended Movement 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Product Quality Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Laceration(s) 8 8
Insufficient Information 4 4
Foreign Body In Patient 2 2
Blood Loss 1 1
Injury 1 1
Exposure to Body Fluids 1 1
No Patient Involvement 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
2 Sklar Instruments II Jan-16-2025
3 Steris Corporation II Oct-12-2022
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