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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, thermal ablation, endometrial
Product CodeMNB
Device Class 3

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

Device Problems
No Known Device Problem 529
Device handling issue 274
Fluid leak 236
Leak 228
Unknown (for use when the device problem is not known) 220
Other (for use when an appropriate device code cannot be identified) 71
Loss of power 44
Balloon leak(s) 35
Decrease in pressure 29
Not Applicable 29
Crack 26
Overheating of device or device component 25
Device Issue 19
No Information 18
Material perforation 17
Melted 17
Break 14
Alarm, audible 14
Normal 13
Balloon burst 12
Detachment of device component 11
Device operates differently than expected 11
Device displays error message 10
Material puncture 10
Device stops intermittently 9
Device alarm system issue 8
Alarm, error of warning 7
Burst 7
Smoking 7
Burn of device or device component 6
Cool, failure to 6
Foreign material present in device 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
Use of Device Issue 4
Sterility 3
Device inoperable 3
Pierce 3
Bent 3
No display or display failure 3
Foreign material 3
Material frayed 3
Filling problem 2
Collapse 2
Occlusion within device 2
Delivered as unsterile product 2
Excess flow or overinfusion 2
Heat, failure to 2
Insufficient heating 2
Source, detachment from 2
Retraction problem 2
Material separation 2
Defective component 2
Tube(s), defective 2
Seal, defective 2
Component missing 2
No code available 2
Device packaging compromised 2
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
Out-of-box failure 1
Invalid sensing 1
Improper or incorrect procedure or method 1
High Readings 1
Tear, rip or hole in device packaging 1
Probe failure 1
Pumping stopped 1
Therapy delivered to incorrect body area 1
Difficult to remove 1
Hose line rupture 1
IV pole, detachment of parts from 1
Difficult to insert 1
Lead(s), fracture of 1
Loose or intermittent connection 1
Unintended system motion 1
Contamination during use 1
Alarm, failure of warning 1
Adaptor, failure of 1
Defective Alarm 1
Total Device Problems 2126

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

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