• 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 camera, television, endoscopic, without audio
Regulation Description Surgical camera and accessories.
Product CodeFWF
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 9 9
2019 40 40
2020 23 23
2021 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Intermittent Continuity 25 25
Intermittent Loss of Power 10 10
Display or Visual Feedback Problem 8 8
Break 7 7
Electrical /Electronic Property Problem 7 7
Intermittent Capture 5 5
Power Problem 5 5
Failure to Power Up 5 5
Image Display Error/Artifact 4 4
Poor Quality Image 3 3
Use of Device Problem 3 3
Output Problem 3 3
Intermittent Energy Output 3 3
Operating System Becomes Nonfunctional 2 2
Detachment of Device or Device Component 2 2
Physical Resistance/Sticking 2 2
Intermittent Communication Failure 2 2
No Visual Prompts/Feedback 1 1
Unintended Movement 1 1
Computer Software Problem 1 1
Sensing Intermittently 1 1
Device Stops Intermittently 1 1
Device Contamination with Chemical or Other Material 1 1
Optical Distortion 1 1
Image Orientation Incorrect 1 1
Loose or Intermittent Connection 1 1
Device Operates Differently Than Expected 1 1
No Display/Image 1 1
Blocked Connection 1 1
Component or Accessory Incompatibility 1 1
Computer Operating System Problem 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 50 50
No Clinical Signs, Symptoms or Conditions 21 21
Not Applicable 16 16
No Code Available 5 5
No Known Impact Or Consequence To Patient 3 3
Tissue Damage 2 2
Intraoperative Pain 1 1
Laceration(s) 1 1

-
-