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