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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 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Break 123 123
Detachment of Device or Device Component 31 31
Adverse Event Without Identified Device or Use Problem 16 16
Fracture 11 11
Mechanical Problem 10 10
Material Fragmentation 9 9
Thermal Decomposition of Device 8 8
Material Twisted/Bent 8 8
Contamination 7 7
Crack 6 6
Difficult to Open or Close 5 5
Obstruction of Flow 5 5
Material Deformation 4 4
Physical Resistance/Sticking 4 4
Poor Quality Image 4 4
Loose or Intermittent Connection 3 3
Sparking 3 3
Component Missing 3 3
Scratched Material 3 3
Material Separation 2 2
Electrical /Electronic Property Problem 2 2
Optical Problem 2 2
Degraded 2 2
Image Display Error/Artifact 2 2
Material Frayed 2 2
Melted 2 2
Material Disintegration 2 2
Difficult to Fold, Unfold or Collapse 2 2
Defective Component 1 1
Electro-Static Discharge 1 1
Failure to Clean Adequately 1 1
Material Integrity Problem 1 1
Unintended Electrical Shock 1 1
Device Markings/Labelling Problem 1 1
Difficult to Remove 1 1
Peeled/Delaminated 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Dent in Material 1 1
Failure to Align 1 1
Fire 1 1
Use of Device Problem 1 1
Material Split, Cut or Torn 1 1
Device Contaminated During Manufacture or Shipping 1 1
Pitted 1 1
Device Handling Problem 1 1
Failure to Form Staple 1 1
Difficult to Advance 1 1
Mechanical Jam 1 1
Arcing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 196 196
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
Burn(s) 3 3
Device Embedded In Tissue or Plaque 3 3
Urinary Incontinence 2 2
Rupture 2 2
Insufficient Information 2 2
Tissue Damage 2 2
Hemorrhage/Bleeding 2 2
Internal Organ Perforation 2 2
Uterine Perforation 1 1
Hyponatremia 1 1
No Code Available 1 1
Perforation 1 1
Burn, Thermal 1 1
Blood Loss 1 1
Urethral Stenosis/Stricture 1 1
No Patient Involvement 1 1
Shock 1 1

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