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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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 38 38
Sparking 10 10
Material Fragmentation 9 9
Temperature Problem 5 5
Electrical /Electronic Property Problem 4 4
Fracture 4 4
Inappropriate/Inadequate Shock/Stimulation 3 3
Overheating of Device 3 3
Material Separation 3 3
Unintended Power Up 3 3
Detachment Of Device Component 3 3
Grounding Malfunction 3 3
Fire 3 3
Mechanical Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Unintended Electrical Shock 3 3
Device Handling Problem 2 2
Detachment of Device or Device Component 2 2
Bent 2 2
Thermal Decomposition of Device 2 2
Inadequate Service 2 2
Device Stops Intermittently 2 2
Arcing of Electrodes 2 2
Component Missing 1 1
Device Issue 1 1
Defective Device 1 1
Use of Device Problem 1 1
Ambient Noise Problem 1 1
Connection Problem 1 1
Smoking 1 1
Failure To Service 1 1
Therapy Delivered to Incorrect Body Area 1 1
Component Falling 1 1
Degraded 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Melted 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Integrity Problem 1 1
Excessive Heating 1 1
Output Problem 1 1
Power Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 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 14 14
No Known Impact Or Consequence To Patient 13 13
Foreign Body In Patient 12 12
Insufficient Information 6 6
Electric Shock 6 6
Burn, Thermal 3 3
Full thickness (Third Degree) Burn 3 3
Lead(s), Burn(s) From 3 3
Flashers 3 3
Hemorrhage/Bleeding 3 3
No Patient Involvement 3 3
No Code Available 2 2
Laceration(s) 2 2
Shock 2 2
Burn(s) 2 2
Death 1 1
Electrocution 1 1
Hearing Loss 1 1
Tissue Damage 1 1
Twitching 1 1
Perforation 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Blood Loss 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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