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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
2017 18 18
2018 25 25
2019 39 39
2020 21 21
2021 17 17
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 64 64
Material Fragmentation 16 16
Fracture 13 13
Delivered as Unsterile Product 8 8
Contamination /Decontamination Problem 8 8
Material Integrity Problem 6 6
Detachment Of Device Component 5 5
Mechanical Problem 5 5
Detachment of Device or Device Component 5 5
Failure to Cut 5 5
Device Markings/Labelling Problem 3 3
Product Quality Problem 3 3
Material Separation 3 3
Inaccurate Information 3 3
Mechanical Jam 2 2
Device Fell 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Dull, Blunt 2 2
Defective Device 2 2
Component Missing 2 2
Structural Problem 2 2
Failure to Align 2 2
Device Slipped 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Separation Problem 1 1
Flaked 1 1
Loose or Intermittent Connection 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Discolored 1 1
Fire 1 1
Pitted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 41 41
No Clinical Signs, Symptoms or Conditions 29 29
No Consequences Or Impact To Patient 23 23
Foreign Body In Patient 13 13
No Patient Involvement 8 8
Device Embedded In Tissue or Plaque 5 5
No Information 4 4
Insufficient Information 4 4
Bowel Perforation 2 2
Pain 2 2
Swelling 1 1
Tissue Damage 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
Patient Problem/Medical Problem 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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