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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 2017
9 14 13 18 18 8 17 20 7 5 1

Device Problems
No Known Device Problem 532
Device handling issue 274
Fluid leak 242
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 Issue 19
Material perforation 17
Melted 17
Device operates differently than expected 15
Break 14
Alarm, audible 14
Normal 13
Balloon burst 12
Detachment of device component 11
Material puncture 10
Device displays error message 10
Device stops intermittently 9
Device alarm system issue 8
Alarm, error of warning 7
Burst 7
Smoking 7
Foreign material present in device 7
Malfunction 6
Wire(s), breakage of 6
Burn of device or device component 6
Cool, failure to 6
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
Device damaged prior to use 5
Overfill 5
Use of Device Issue 4
Kinked 4
Unsealed device packaging 4
Mechanical issue 4
Failure to power-up 4
Increase in pressure 4
Bent 4
No display or display failure 3
Foreign material 3
Material frayed 3
Sterility 3
Device inoperable 3
Pierce 3
No code available 3
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
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
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
False reading from device non-compliance 1
Cooling system, failure of 1
Corrosion 1
Disengaged 1
Erratic display 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
Unintended system motion 1
Total Device Problems 2145

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

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