Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
Electrical /Electronic Property Problem 4 4
Fracture 4 4
Detachment Of Device Component 3 3
Overheating of Device 3 3
Material Separation 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Mechanical Problem 3 3
Fire 3 3
Grounding Malfunction 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Unintended Electrical Shock 3 3
Unintended Power Up 3 3
Thermal Decomposition of Device 2 2
Device Handling Problem 2 2
Bent 2 2
Inadequate Service 2 2
Detachment of Device or Device Component 2 2
Device Stops Intermittently 2 2
Arcing of Electrodes 2 2
Use of Device Problem 1 1
Component Missing 1 1
Device Damaged by Another Device 1 1
Connection Problem 1 1
Melted 1 1
Material Discolored 1 1
Flare or Flash 1 1
Smoking 1 1
Entrapment of Device 1 1
Defective Device 1 1
Output Problem 1 1
Material Integrity Problem 1 1
Degraded 1 1
Difficult to Insert 1 1
Insufficient Information 1 1
Ambient Noise Problem 1 1
Intermittent Energy Output 1 1
Device Disinfection Or Sterilization Issue 1 1
Electrical Shorting 1 1
Device Operates Differently Than Expected 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
Failure To Service 1 1
Therapy Delivered to Incorrect Body Area 1 1
Device Issue 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

-
-