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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
2020 35 35
2021 35 35
2022 21 21
2023 28 28
2024 33 33
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 56 56
Dull, Blunt 16 16
Insufficient Information 14 14
Fracture 12 12
Material Integrity Problem 9 9
Unsealed Device Packaging 7 7
Failure to Cut 6 6
Difficult to Remove 3 3
Packaging Problem 3 3
Difficult to Open or Close 3 3
Fail-Safe Did Not Operate 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Handling Problem 2 2
Degraded 2 2
Entrapment of Device 2 2
Defective Component 1 1
Material Too Soft/Flexible 1 1
Extra Components 1 1
Delivered as Unsterile Product 1 1
Material Discolored 1 1
Difficult to Open or Remove Packaging Material 1 1
Material Separation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Appropriate Term/Code Not Available 1 1
Material Fragmentation 1 1
Contamination /Decontamination Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Nonstandard Device 1 1
Material Too Rigid or Stiff 1 1
Defective Device 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Device Contamination with Chemical or Other Material 1 1
Detachment of Device or Device Component 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 96 96
Insufficient Information 18 18
Foreign Body In Patient 14 14
No Known Impact Or Consequence To Patient 8 8
Laceration(s) 6 6
No Consequences Or Impact To Patient 4 4
Device Embedded In Tissue or Plaque 3 3
Injury 3 3
Hemorrhage/Bleeding 1 1
Tissue Damage 1 1
Nervous System Injury 1 1
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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