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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urethroscope
Product CodeFGC
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
PERCUVISION LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 1 1
2021 2 2
2022 33 33
2023 346 346
2024 288 288

Device Problems MDRs with this Device Problem Events in those MDRs
Break 435 435
Detachment of Device or Device Component 92 92
Crack 48 48
Loose or Intermittent Connection 27 27
Poor Quality Image 24 24
Component Missing 24 24
Mechanical Problem 17 17
Material Twisted/Bent 15 15
Material Integrity Problem 6 6
Failure to Align 5 5
Display or Visual Feedback Problem 4 4
No Display/Image 4 4
Material Deformation 4 4
Defective Component 4 4
Material Separation 4 4
Thermal Decomposition of Device 4 4
Disconnection 3 3
Poor Visibility 3 3
Optical Problem 3 3
Image Display Error/Artifact 3 3
Degraded 3 3
Scratched Material 2 2
Device Fell 2 2
Material Split, Cut or Torn 2 2
Separation Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Unraveled Material 1 1
Fogging 1 1
Material Fragmentation 1 1
Unintended Movement 1 1
Incomplete or Inadequate Connection 1 1
Pitted 1 1
Physical Resistance/Sticking 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Excessive Heating 1 1
Overheating of Device 1 1
Optical Obstruction 1 1
Naturally Worn 1 1
Corroded 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 666 666
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Gastrointestinal Problem 1 1
Perforation 1 1
Rupture 1 1
Ecchymosis 1 1
Laceration(s) 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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