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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
2017 73 73
2018 80 80
2019 53 53
2020 35 35
2021 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Break 151 151
Dull, Blunt 26 26
Tear, Rip or Hole in Device Packaging 19 19
Material Integrity Problem 15 15
Mechanical Problem 13 13
Failure to Cut 11 11
Detachment Of Device Component 9 9
Manufacturing, Packaging or Shipping Problem 6 6
Device Operates Differently Than Expected 5 5
Fracture 5 5
Difficult to Remove 5 5
Material Fragmentation 4 4
Component Falling 4 4
Corroded 4 4
Detachment of Device or Device Component 4 4
Product Quality Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Packaging Problem 3 3
Material Discolored 3 3
Entrapment of Device 2 2
Hole In Material 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Packaging Compromised 2 2
Device Handling Problem 2 2
Material Split, Cut or Torn 1 1
Device Fell 1 1
Difficult to Advance 1 1
Material Deformation 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Disinfection Or Sterilization Issue 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Structural Problem 1 1
Unintended Ejection 1 1
Crack 1 1
Retraction Problem 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Incomplete or Missing Packaging 1 1
Device Contamination with Body Fluid 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 74 74
Foreign Body In Patient 61 61
No Information 31 31
No Clinical Signs, Symptoms or Conditions 31 31
No Consequences Or Impact To Patient 23 23
Injury 12 12
No Patient Involvement 11 11
Insufficient Information 9 9
Device Embedded In Tissue or Plaque 7 7
Laceration(s) 7 7
Tissue Damage 4 4
No Code Available 4 4
Patient Problem/Medical Problem 1 1
Nervous System Injury 1 1
Sedation 1 1
Pain 1 1
Burn(s) 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1

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