• 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 rongeur, powered
Regulation Description Powered rongeur.
Product CodeHAD
Regulation Number 882.4845
Device Class 2

MDR Year MDR Reports MDR Events
2015 15 15
2016 10 10
2017 4 4
2018 4 4
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Detachment of Device or Device Component 5 5
Use of Device Problem 3 3
Difficult to Open or Close 2 2
Naturally Worn 1 1
Tip 1 1
Separation Failure 1 1
Physical Resistance 1 1
Device Operates Differently Than Expected 1 1
Mechanical Problem 1 1
Material Separation 1 1
Air Leak 1 1
Bent 1 1
Shaft 1 1
Jaw 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Loose or Intermittent Connection 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 24 24
No Consequences Or Impact To Patient 7 7
Tissue Damage 2 2
No Code Available 2 2

-
-