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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scissors, general, surgical
Product CodeLRW
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 39 39
2020 21 21
2021 17 17
2022 16 16
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Material Fragmentation 17 17
Fracture 13 13
Material Integrity Problem 5 5
Mechanical Problem 5 5
Detachment of Device or Device Component 4 4
Device Markings/Labelling Problem 3 3
Product Quality Problem 3 3
Inaccurate Information 3 3
Mechanical Jam 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 2 2
Material Separation 2 2
Component Missing 2 2
Structural Problem 2 2
Failure to Align 2 2
Failure to Cut 2 2
Defective Device 2 2
Difficult to Open or Close 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Dull, Blunt 1 1
Device Slipped 1 1
Pitted 1 1
Material Discolored 1 1
Flaked 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 22 22
No Consequences Or Impact To Patient 13 13
No Patient Involvement 7 7
Foreign Body In Patient 7 7
Insufficient Information 7 7
Device Embedded In Tissue or Plaque 3 3
Bowel Perforation 2 2
Injury 1 1
Ambulation Difficulties 1 1
Fall 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Pain 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
2 Steris Corporation II Jan-17-2024
3 Stradis Medical, LLC dba Stradis Healthcare II Aug-18-2022
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