• 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 image, illumination, fiberoptic, for endoscope
Product CodeFFS
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 17 17
2020 56 56
2021 57 57
2022 10 10
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 52 52
Overheating of Device 47 47
Protective Measures Problem 16 16
Unexpected Shutdown 15 15
Insufficient Information 10 10
Power Problem 6 6
Adverse Event Without Identified Device or Use Problem 2 2
Smoking 2 2
Electrical /Electronic Property Problem 2 2
No Apparent Adverse Event 2 2
Image Display Error/Artifact 1 1
Melted 1 1
Poor Quality Image 1 1
Device Emits Odor 1 1
Defective Component 1 1
Sparking 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Optical Obstruction 1 1
Break 1 1
No Display/Image 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88 88
No Patient Involvement 33 33
No Known Impact Or Consequence To Patient 19 19
No Information 3 3
Full thickness (Third Degree) Burn 2 2
No Consequences Or Impact To Patient 2 2
Laceration(s) 1 1
Partial thickness (Second Degree) Burn 1 1
Insufficient Information 1 1

-
-