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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 2

Device Problems
No Known Device Problem 515
Device handling issue 274
Leak 228
Fluid leak 224
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 25
Overheating of device or device component 25
Device Issue 19
Material perforation 17
No Information 17
Melted 17
Alarm, audible 14
Normal 13
Break 12
Balloon burst 12
Detachment of device component 11
Material puncture 10
Device displays error message 10
Device operates differently than expected 9
Device stops intermittently 9
Alarm, error of warning 7
Burst 7
Smoking 7
Cool, failure to 6
Foreign material present in device 6
Wire(s), breakage of 6
Burn of device or device component 6
Device alarm system issue 6
Malfunction 6
Device damaged prior to use 5
Component(s), broken 5
Hole in material 5
Device clogged 5
Tears, rips, holes in device, device material 5
Component(s), overheating of 5
Overfill 5
Use of Device Issue 4
Electrical issue 4
Increase in pressure 4
Failure to power-up 4
Unsealed device packaging 4
Mechanical issue 4
Kinked 4
Material frayed 3
No display or display failure 3
Device inoperable 3
Sterility 3
Bent 3
Foreign material 3
Pierce 3
Defective component 2
Tube(s), defective 2
Retraction problem 2
No code available 2
Component missing 2
Insufficient heating 2
Delivered as unsterile product 2
Occlusion within device 2
Source, detachment from 2
Collapse 2
Filling problem 2
Heat, failure to 2
Material separation 2
Device packaging compromised 2
Excess flow or overinfusion 2
Seal, defective 2
Fluid/volume, increased 1
Material deformation 1
Cooling system, failure of 1
Disengaged 1
Difficult to fold or unfold 1
Therapy delivered to incorrect body area 1
Probe failure 1
Material fragmentation 1
Alarm, failure of warning 1
Expulsion 1
Device or device component damaged by another device 1
Out-of-box failure 1
Lead(s), fracture of 1
Pumping stopped 1
Detachment of device or device component 1
Loose or intermittent connection 1
Defective Alarm 1
Erratic display 1
Restricted flowrate 1
Grounding malfunction 1
Difficult to insert 1
Unintended system motion 1
Invalid sensing 1
High Readings 1
Failure to fold 1
Chemical issue 1
Connection issue 1
Electrical power problem 1
Heat 1
Total Device Problems 2091

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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