• 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 Back To Search Results
Device device, thermal ablation, endometrial
Product CodeMNB
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
9 14 13 18 18 8 17 20 7 5 6

Device Problems
No Known Device Problem 541
Device handling issue 274
Fluid leak 246
Leak 228
Unknown (for use when the device problem is not known) 220
Other (for use when an appropriate device code cannot be identified) 70
Loss of power 44
Balloon leak(s) 35
Decrease in pressure 29
Not Applicable 29
Crack 26
Overheating of device or device component 25
No Information 20
Device operates differently than expected 19
Device Issue 19
Material perforation 17
Melted 17
Break 16
Alarm, audible 14
Normal 13
Balloon burst 12
Detachment of device component 11
Material puncture 10
Device displays error message 10
Smoking 9
Device stops intermittently 9
Device alarm system issue 8
Foreign material present in device 8
Alarm, error of warning 7
Burst 7
Burn of device or device component 6
Cool, failure to 6
Malfunction 6
Wire(s), breakage of 6
Device damaged prior to use 5
Overfill 5
Component(s), broken 5
Electrical issue 5
Device clogged 5
Component(s), overheating of 5
Tears, rips, holes in device, device material 5
Hole in material 5
Kinked 4
Unsealed device packaging 4
Mechanical issue 4
Failure to power-up 4
Increase in pressure 4
Bent 4
Use of Device Issue 4
No code available 3
No display or display failure 3
Foreign material 3
Material frayed 3
Sterility 3
Device inoperable 3
Pierce 3
Occlusion within device 2
Delivered as unsterile product 2
Loose or intermittent connection 2
Excess flow or overinfusion 2
Heat, failure to 2
Insufficient heating 2
Source, detachment from 2
Retraction problem 2
Material separation 2
Filling problem 2
Collapse 2
Device packaging compromised 2
Tear, rip or hole in device packaging 2
Defective component 2
Tube(s), defective 2
Seal, defective 2
Component missing 2
Out-of-box failure 1
Invalid sensing 1
High Readings 1
Improper or incorrect procedure or method 1
Electrical power problem 1
Expulsion 1
Device or device component damaged by another device 1
Failure to fire 1
Fluid/volume, increased 1
Chemical issue 1
Connection issue 1
Detachment of device or device component 1
Human-Device Interface Issue 1
Material deformation 1
Contamination during use 1
Alarm, failure of warning 1
Adaptor, failure of 1
Defective Alarm 1
Alarm, failure of low flow 1
Not audible alarm 1
Restricted flowrate 1
Difficult to fold or unfold 1
Failure to fold 1
Grounding malfunction 1
Heat 1
Material fragmentation 1
Emergency stop button or switch failure 1
Total Device Problems 2167

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 1 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Sep-22-2009
2 Boston Scientific Corporation II Mar-31-2007
3 Hologic, Inc II Feb-26-2014

-
-