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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 195 195

Device Problems MDRs with this Device Problem Events in those MDRs
Break 383 383
Detachment of Device or Device Component 75 75
Crack 43 43
Poor Quality Image 23 23
Loose or Intermittent Connection 20 20
Component Missing 18 18
Mechanical Problem 17 17
Material Twisted/Bent 10 10
Material Integrity Problem 5 5
Material Deformation 4 4
Thermal Decomposition of Device 4 4
No Display/Image 4 4
Display or Visual Feedback Problem 4 4
Degraded 3 3
Material Separation 3 3
Failure to Align 3 3
Image Display Error/Artifact 3 3
Defective Component 3 3
Optical Problem 3 3
Scratched Material 2 2
Material Split, Cut or Torn 2 2
Device Fell 2 2
Disconnection 2 2
Separation Problem 2 2
Poor Visibility 1 1
Unraveled Material 1 1
Pitted 1 1
Fogging 1 1
Fracture 1 1
Material Fragmentation 1 1
Detachment Of Device Component 1 1
Corroded 1 1
Incomplete or Inadequate Connection 1 1
Physical Resistance/Sticking 1 1
Unintended Movement 1 1
Naturally Worn 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 573 573
Hemorrhage/Bleeding 2 2
Laceration(s) 1 1
Perforation 1 1
No Consequences Or Impact To Patient 1 1
Rupture 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Gastrointestinal Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ecchymosis 1 1

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