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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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 52 52
Detachment of Device or Device Component 52 52
Break 25 25
Difficult to Open or Close 19 19
Detachment Of Device Component 11 11
Material Frayed 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Material Deformation 6 6
Material Split, Cut or Torn 5 5
Difficult to Remove 5 5
Sticking 3 3
Entrapment of Device 2 2
Torn Material 2 2
Device Fell 2 2
Material Twisted/Bent 2 2
Packaging Problem 2 2
Material Separation 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Inoperable 2 2
Migration or Expulsion of Device 1 1
Difficult to Advance 1 1
Unsealed Device Packaging 1 1
Defective Device 1 1
Degraded 1 1
Shipping Damage or Problem 1 1
Delivered as Unsterile Product 1 1
Retraction Problem 1 1
Device Operates Differently Than Expected 1 1
Appropriate Term/Code Not Available 1 1
Loose or Intermittent Connection 1 1
Deformation Due to Compressive Stress 1 1
Component Falling 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 51 51
No Known Impact Or Consequence To Patient 18 18
Foreign Body In Patient 6 6
Insufficient Information 5 5
No Code Available 3 3
Pain 3 3
Device Embedded In Tissue or Plaque 3 3
Discomfort 2 2
Sepsis 1 1
Hematuria 1 1
Hematoma 1 1
Inflammation 1 1
Perforation 1 1
Laceration(s) of Esophagus 1 1
Obstruction/Occlusion 1 1
Urethral Stenosis/Stricture 1 1
Injury 1 1
Unspecified Kidney or Urinary Problem 1 1
Tissue Damage 1 1
Myocardial Infarction 1 1
Hemorrhage/Bleeding 1 1
Urinary Tract Infection 1 1

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