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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2021 35 35
2022 21 21
2023 28 28
2024 33 33
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 52 52
Insufficient Information 19 19
Unsealed Device Packaging 16 16
Material Integrity Problem 10 10
Fracture 10 10
Dull, Blunt 5 5
Packaging Problem 3 3
Difficult to Open or Close 3 3
Device Contaminated During Manufacture or Shipping 2 2
Fail-Safe Did Not Operate 2 2
Degraded 2 2
Material Discolored 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Handling Problem 2 2
Appropriate Term/Code Not Available 2 2
Corroded 2 2
Entrapment of Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Defective Component 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Fail-Safe Problem 1 1
Structural Problem 1 1
Failure to Cut 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Nonstandard Device 1 1
Human-Device Interface Problem 1 1
Material Too Soft/Flexible 1 1
Extra Components 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 113
Insufficient Information 21 21
Foreign Body In Patient 11 11
Laceration(s) 6 6
Device Embedded In Tissue or Plaque 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Southmedic, Inc. II Nov-23-2022
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