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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Product CodeMEQ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
11 14 10 7 6 4 2 4 2 0

Device Problems
Balloon leak(s) 181
Alarm, error of warning 113
Unknown (for use when the device problem is not known) 70
Low readings 60
False reading from device non-compliance 55
Sensor problems 41
Pressure, insufficient 40
Leak 39
Balloon rupture 36
Other (for use when an appropriate device code cannot be identified) 33
Deflation issue 32
Device displays error message 30
Difficult to insert 26
No Known Device Problem 24
Decrease in pressure 22
Folded 21
Inflation issue 18
Bent 15
Loss of power 15
High Readings 13
Tears, rips, holes in device, device material 12
Difficult to position 11
Unable to obtain readings 9
Balloon burst 7
Computer software issue 6
Pressure issue 6
Kinked 5
Device stops intermittently 5
Failure to power-up 4
Component(s), broken 4
Migration of device or device component 4
Delivered as unsterile product 3
False device output 3
Fluid leak 3
Crack 3
Break 3
Increased pump speed 3
Smoking 3
Device Issue 3
Failure to advance 3
Balloon pinhole 3
Pumping issue 2
Tear, rip or hole in device packaging 2
Failure to read input signal 2
Sensing intermittently 2
Failure to sense 2
Increase in pressure 2
Decreased pump speed 2
Performance 2
Changes in ambient temperature in device environment 2
Connection error 2
Alarm, audible 2
Filling problem 2
Heat, failure to 2
Insufficient heating 2
Output above specifications 2
Loose or intermittent connection 2
Device maintenance issue 1
Mechanical issue 1
Output, high 1
Unsealed device packaging 1
Inaccurate flowrate 1
Detachment of device component 1
Dislodged 1
No display or display failure 1
Electrical issue 1
Failure to deliver energy 1
Inability to autofill 1
Burst 1
Blank screen 1
Prep, failure to 1
Pressure sensor failure 1
Pumping stopped 1
Material puncture 1
Difficult to remove 1
Retraction problem 1
Material rupture 1
Device inoperable 1
Noise 1
Cut in material 1
Defective component 1
Out-of-box failure 1
Wire(s), breakage of 1
Catheter withdrawal interference 1
Applicator failure 1
Failure to align 1
Total Device Problems 1048

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 1 1 0 0 0 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 Jul-28-2009
2 Urologix, Inc. II Jun-30-2011
3 Urologix, Inc. II Mar-19-2010
4 Urologix, Inc. II Apr-05-2007

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