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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
2014 29 29
2015 12 12
2016 1 1
2017 9 9
2018 4 4
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 39 39
Sparking 10 10
Material Fragmentation 9 9
Temperature Problem 5 5
Fracture 4 4
Electrical /Electronic Property Problem 4 4
Fire 3 3
Mechanical Problem 3 3
Grounding Malfunction 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Material Separation 3 3
Unintended Electrical Shock 3 3
Unintended Power Up 3 3
Overheating of Device 3 3
Detachment Of Device Component 3 3
Thermal Decomposition of Device 2 2
Inadequate Service 2 2
Detachment of Device or Device Component 2 2
Device Handling Problem 2 2
Bent 2 2
Device Stops Intermittently 2 2
Arcing of Electrodes 2 2
Connection Problem 1 1
Melted 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Smoking 1 1
Intermittent Energy Output 1 1
Flare or Flash 1 1
Use of Device Problem 1 1
Material Discolored 1 1
Component Missing 1 1
Failure To Service 1 1
Therapy Delivered to Incorrect Body Area 1 1
Component Falling 1 1
Loose or Intermittent Connection 1 1
Device Issue 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Appropriate Term/Code Not Available 1 1
Power Problem 1 1
Excessive Heating 1 1
Device Operates Differently Than Expected 1 1
Ambient Noise Problem 1 1
Electrical Shorting 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Damaged by Another Device 1 1
Degraded 1 1
Difficult to Insert 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 35 35
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 13 13
Foreign Body In Patient 12 12
Electric Shock 6 6
Insufficient Information 6 6
Burn, Thermal 3 3
Flashers 3 3
No Patient Involvement 3 3
Hemorrhage/Bleeding 3 3
Lead(s), Burn(s) From 3 3
Full thickness (Third Degree) Burn 3 3
No Code Available 2 2
Burn(s) 2 2
Laceration(s) 2 2
Shock 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Hearing Loss 1 1
Perforation 1 1
Blood Loss 1 1
Twitching 1 1
Electrocution 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Fibrosis 1 1
Device Embedded In Tissue or Plaque 1 1

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