• 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
2017 19 19
2018 19 19
2019 17 17
2020 56 56
2021 57 57
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 57 57
Failure to Power Up 52 52
Protective Measures Problem 16 16
Unexpected Shutdown 13 13
Power Problem 9 9
Insufficient Information 8 8
Loss of Power 6 6
Noise, Audible 4 4
Device Displays Incorrect Message 4 4
Electrical Shorting 3 3
Thermal Decomposition of Device 3 3
No Display/Image 2 2
Melted 2 2
Device Emits Odor 2 2
Defective Component 2 2
Inadequate Lighting 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Operates Differently Than Expected 2 2
No Apparent Adverse Event 2 2
Break 2 2
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Electrical Power Problem 1 1
Sparking 1 1
Optical Obstruction 1 1
Device Issue 1 1
Smoking 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
No Device Output 1 1
Poor Quality Image 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Image Display Error/Artifact 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
No Known Impact Or Consequence To Patient 46 46
No Patient Involvement 33 33
No Information 8 8
No Consequences Or Impact To Patient 5 5
Full thickness (Third Degree) Burn 3 3
Blurred Vision 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Jun-05-2017
-
-