• 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 urethroscope
Product CodeFGC
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 33 33
2023 346 346
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 273 273
Detachment of Device or Device Component 56 56
Crack 35 35
Poor Quality Image 18 18
Mechanical Problem 17 17
Loose or Intermittent Connection 16 16
Component Missing 15 15
Material Twisted/Bent 6 6
Material Deformation 4 4
Defective Component 3 3
Image Display Error/Artifact 3 3
No Display/Image 3 3
Display or Visual Feedback Problem 2 2
Disconnection 2 2
Optical Problem 2 2
Material Split, Cut or Torn 2 2
Device Fell 2 2
Separation Problem 2 2
Poor Visibility 1 1
Physical Resistance/Sticking 1 1
Scratched Material 1 1
Unintended Movement 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Thermal Decomposition of Device 1 1
Corroded 1 1
Fogging 1 1
Fracture 1 1
Material Separation 1 1
Unraveled Material 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 407 407
Hemorrhage/Bleeding 2 2
Laceration(s) 1 1
Perforation 1 1
Rupture 1 1
Unspecified Gastrointestinal Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ecchymosis 1 1

-
-