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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscope, ac-powered and accessories
Product CodeGCP
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 19 19
2020 18 18
2021 12 12
2022 26 26
2023 100 100
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Break 103 103
Detachment of Device or Device Component 28 28
Adverse Event Without Identified Device or Use Problem 16 16
Fracture 10 10
Mechanical Problem 10 10
Material Fragmentation 9 9
Thermal Decomposition of Device 8 8
Contamination 7 7
Material Twisted/Bent 6 6
Obstruction of Flow 5 5
Crack 5 5
Difficult to Open or Close 4 4
Material Deformation 3 3
Physical Resistance/Sticking 3 3
Optical Problem 2 2
Scratched Material 2 2
Sparking 2 2
Material Separation 2 2
Difficult to Fold, Unfold or Collapse 2 2
Component Missing 2 2
Material Disintegration 2 2
Material Frayed 2 2
Image Display Error/Artifact 2 2
Melted 2 2
Poor Quality Image 2 2
Peeled/Delaminated 1 1
Pitted 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Fire 1 1
Corroded 1 1
Use of Device Problem 1 1
Defective Component 1 1
Failure to Align 1 1
Failure to Form Staple 1 1
Arcing 1 1
Material Integrity Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Advance 1 1
Device Handling Problem 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 161 161
Foreign Body In Patient 12 12
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 10 10
Bacterial Infection 4 4
Device Embedded In Tissue or Plaque 3 3
Tissue Damage 2 2
Urinary Incontinence 2 2
Insufficient Information 2 2
Burn(s) 2 2
Hemorrhage/Bleeding 2 2
Rupture 2 2
Burn, Thermal 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Perforation 1 1
Shock 1 1
Uterine Perforation 1 1
No Code Available 1 1
Hyponatremia 1 1
Urethral Stenosis/Stricture 1 1

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