• 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 light, catheter, fiberoptic, glass, ureteral
Product CodeFCS
Regulation Number 876.4020
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 8 8
2021 6 6
2022 19 19
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Packaging Problem 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Device Contamination with Chemical or Other Material 6 6
Output Problem 5 5
Contamination /Decontamination Problem 5 5
Device Unsafe to Use in Environment 4 4
Contamination 4 4
Use of Device Problem 3 3
Patient-Device Incompatibility 3 3
Insufficient Information 3 3
Therapeutic or Diagnostic Output Failure 2 2
Break 2 2
Structural Problem 2 2
Expiration Date Error 2 2
Fracture 2 2
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Device Contamination with Body Fluid 1 1
Electrical /Electronic Property Problem 1 1
Defective Device 1 1
Difficult to Advance 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Markings/Labelling Problem 1 1
Optical Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Insufficient Information 22 22
No Known Impact Or Consequence To Patient 7 7
Renal Failure 3 3
Hemorrhage/Bleeding 2 2
Genital Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Perforation 1 1
Uterine Perforation 1 1
Blood Loss 1 1
Burn(s) 1 1

-
-