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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dislodger, stone, flexible
Product CodeFGO
Regulation Number 876.4680
Device Class 2

MDR Year MDR Reports MDR Events
2014 4 4
2015 15 15
2016 21 21
2017 17 17
2018 14 14
2019 25 25
2020 19 19
2021 14 14
2022 18 18
2023 14 14
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 52 52
Detachment of Device or Device Component 50 50
Break 24 24
Difficult to Open or Close 19 19
Detachment Of Device Component 11 11
Material Frayed 6 6
Material Deformation 6 6
Material Split, Cut or Torn 5 5
Difficult to Remove 5 5
Sticking 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Packaging Problem 2 2
Torn Material 2 2
Material Twisted/Bent 2 2
Device Fell 2 2
Entrapment of Device 2 2
Device Inoperable 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Separation 2 2
Shipping Damage or Problem 1 1
Retraction Problem 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Component Falling 1 1
Degraded 1 1
Device Operates Differently Than Expected 1 1
Difficult to Advance 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 87 87
No Clinical Signs, Symptoms or Conditions 47 47
No Known Impact Or Consequence To Patient 18 18
Foreign Body In Patient 6 6
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 3 3
No Code Available 3 3
Discomfort 2 2
Pain 2 2
Tissue Damage 1 1
Urinary Tract Infection 1 1
Hemorrhage/Bleeding 1 1
Myocardial Infarction 1 1
Injury 1 1
Laceration(s) of Esophagus 1 1
Hematuria 1 1
Unspecified Kidney or Urinary Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 US Endoscopy Group Inc II Oct-03-2012
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