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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device resectoscope, working element
Product CodeFDC
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 14 14
2020 10 10
2021 5 5
2022 5 5
2023 10 10
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Temperature Problem 5 5
Unintended Electrical Shock 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Material Separation 3 3
Overheating of Device 3 3
Fire 2 2
Mechanical Problem 2 2
Detachment of Device or Device Component 2 2
Sparking 1 1
Intermittent Energy Output 1 1
Smoking 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Difficult to Insert 1 1
Flare or Flash 1 1
Thermal Decomposition of Device 1 1
Device Handling Problem 1 1
Ambient Noise Problem 1 1
Electrical Shorting 1 1
Fracture 1 1
Power Problem 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Connection Problem 1 1
Loose or Intermittent Connection 1 1
Arcing of Electrodes 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 7 7
Insufficient Information 6 6
Foreign Body In Patient 3 3
Full thickness (Third Degree) Burn 3 3
Electric Shock 2 2
Burn, Thermal 2 2
No Known Impact Or Consequence To Patient 2 2
No Patient Involvement 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Perforation 1 1
Burn(s) 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1

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