| Device |
system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
| Product Code | MEQ |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
11
|
14
|
10
|
7
|
6
|
4
|
1
|
|
| 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 |
23 |
| 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 |
1047 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
