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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
2018 25 25
2019 39 39
2020 21 21
2021 17 17
2022 16 16
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 55 55
Material Fragmentation 20 20
Fracture 14 14
Contamination /Decontamination Problem 8 8
Delivered as Unsterile Product 8 8
Detachment of Device or Device Component 6 6
Material Integrity Problem 6 6
Mechanical Problem 5 5
Product Quality Problem 3 3
Material Separation 3 3
Failure to Cut 3 3
Device Markings/Labelling 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
Defective Device 2 2
Structural Problem 2 2
Failure to Align 2 2
Component Missing 2 2
Dull, Blunt 1 1
Device Slipped 1 1
Pitted 1 1
Detachment Of Device Component 1 1
Material Discolored 1 1
Fire 1 1
Flaked 1 1
Separation Problem 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
No Known Impact Or Consequence To Patient 31 31
No Consequences Or Impact To Patient 22 22
Foreign Body In Patient 12 12
No Patient Involvement 8 8
Insufficient Information 5 5
Device Embedded In Tissue or Plaque 4 4
Bowel Perforation 2 2
Pain 2 2
Swelling 1 1
Tissue Damage 1 1
Patient Problem/Medical Problem 1 1
Injury 1 1
Numbness 1 1
Ambulation Difficulties 1 1
Fall 1 1
Headache 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Neurological Deficit/Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stradis Medical, LLC dba Stradis Healthcare II Aug-18-2022
2 Teleflex Medical Europe Ltd II Jun-14-2018
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