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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
2019 26 26
2020 40 40
2021 19 19
2022 60 60
2023 48 48
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 75 75
Break 53 53
Detachment of Device or Device Component 25 25
Retraction Problem 17 17
Difficult to Open or Close 13 13
Material Twisted/Bent 12 12
Mechanical Problem 7 7
Entrapment of Device 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 5 5
Activation Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Device Contaminated During Manufacture or Shipping 2 2
Failure to Deliver Energy 2 2
Material Puncture/Hole 2 2
Difficult to Remove 2 2
Material Fragmentation 2 2
Tear, Rip or Hole in Device Packaging 2 2
Activation Failure 2 2
Material Separation 1 1
Use of Device Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Unsealed Device Packaging 1 1
Fracture 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Human-Device Interface Problem 1 1
Activation, Positioning or Separation Problem 1 1
Separation Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Unintended Movement 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 121 121
No Consequences Or Impact To Patient 43 43
No Known Impact Or Consequence To Patient 18 18
Insufficient Information 13 13
Hemorrhage/Bleeding 6 6
Hematoma 3 3
Perforation 2 2
Foreign Body In Patient 2 2
Unspecified Tissue Injury 2 2
No Code Available 1 1
Tissue Damage 1 1
Anxiety 1 1
Laceration(s) 1 1
Device Embedded In Tissue or Plaque 1 1
Discomfort 1 1
Bacterial Infection 1 1

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