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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device snare, non-electrical
Product CodeFGX
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2015 4 4
2016 4 4
2017 4 4
2018 15 15
2019 26 26
2020 40 40
2021 19 19
2022 60 60
2023 48 48
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 71 71
Break 60 60
Detachment of Device or Device Component 26 26
Retraction Problem 23 23
Difficult to Open or Close 16 16
Material Twisted/Bent 11 11
Mechanical Problem 7 7
Entrapment of Device 6 6
Defective Device 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 5 5
Activation, Positioning or Separation Problem 4 4
Device Contamination with Chemical or Other Material 3 3
Activation Problem 3 3
Activation Failure 2 2
Appropriate Term/Code Not Available 2 2
Device Operates Differently Than Expected 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Fragmentation 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Separation 2 2
Use of Device Problem 2 2
Material Puncture/Hole 2 2
Difficult to Remove 2 2
Unsealed Device Packaging 1 1
Fracture 1 1
Detachment Of Device Component 1 1
Positioning Failure 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Device Handling Problem 1 1
Unintended Movement 1 1
Human-Device Interface Problem 1 1
Mechanics Altered 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 116 116
No Consequences Or Impact To Patient 47 47
No Known Impact Or Consequence To Patient 37 37
Insufficient Information 13 13
Hemorrhage/Bleeding 7 7
Hematoma 3 3
Foreign Body In Patient 2 2
No Information 2 2
Perforation 2 2
Tissue Damage 2 2
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1
Laceration(s) 1 1
Anxiety 1 1
Discomfort 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Jan-11-2014
3 Diversatek Healthcare II Sep-19-2022
4 Endo-Therapeutics, Inc. II Nov-18-2022
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