| Device |
device, thermal ablation, endometrial |
| Product Code | MNB |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
9
|
14
|
13
|
18
|
18
|
8
|
6
|
|
| Device Problems |
| No Known Device Problem |
425 |
| Leak |
225 |
| Unknown (for use when the device problem is not known) |
220 |
| Device handling issue |
207 |
| Fluid leak |
198 |
| Other (for use when an appropriate device code cannot be identified) |
69 |
| Loss of power |
44 |
| Balloon leak(s) |
33 |
| Decrease in pressure |
28 |
| Not Applicable |
27 |
| Overheating of device or device component |
25 |
| Crack |
25 |
| Device Issue |
19 |
| Material perforation |
17 |
| Melted |
17 |
| Alarm, audible |
14 |
| Normal |
13 |
| Balloon burst |
12 |
| No Information |
11 |
| Device displays error message |
10 |
| Material puncture |
10 |
| Device stops intermittently |
9 |
| Detachment of device component |
9 |
| Alarm, error of warning |
7 |
| Break |
6 |
| Burn of device or device component |
6 |
| Cool, failure to |
6 |
| Smoking |
6 |
| Wire(s), breakage of |
6 |
| Device operates differently than expected |
6 |
| Overfill |
5 |
| Malfunction |
5 |
| Device damaged prior to use |
5 |
| Tears, rips, holes in device, device material |
5 |
| Component(s), broken |
5 |
| Device clogged |
5 |
| Component(s), overheating of |
5 |
| Device alarm system issue |
4 |
| Mechanical issue |
4 |
| Kinked |
4 |
| Use of Device Issue |
4 |
| Failure to power-up |
4 |
| Increase in pressure |
4 |
| Device inoperable |
3 |
| Sterility |
3 |
| Material frayed |
3 |
| Unsealed device packaging |
3 |
| Pierce |
3 |
| Bent |
3 |
| No display or display failure |
3 |
| Foreign material |
3 |
| Heat, failure to |
2 |
| Insufficient heating |
2 |
| Hole in material |
2 |
| Filling problem |
2 |
| Collapse |
2 |
| Occlusion within device |
2 |
| Delivered as unsterile product |
2 |
| Excess flow or overinfusion |
2 |
| Material separation |
2 |
| Source, detachment from |
2 |
| Defective component |
2 |
| Tube(s), defective |
2 |
| Seal, defective |
2 |
| Component missing |
2 |
| Foreign material present in device |
2 |
| Device packaging compromised |
2 |
| Electrical power problem |
1 |
| Expulsion |
1 |
| High Readings |
1 |
| Device operational issue |
1 |
| Device or device component damaged by another device |
1 |
| No code available |
1 |
| Out-of-box failure |
1 |
| Tear, rip or hole in device packaging |
1 |
| Failure to fire |
1 |
| Fluid/volume, increased |
1 |
| Chemical issue |
1 |
| Connection issue |
1 |
| Detachment of device or device component |
1 |
| Improper or incorrect procedure or method |
1 |
| Probe failure |
1 |
| Pumping stopped |
1 |
| Difficult to remove |
1 |
| Retraction problem |
1 |
| Difficult to insert |
1 |
| Grounding malfunction |
1 |
| Heat |
1 |
| Lead(s), fracture of |
1 |
| Loose or intermittent connection |
1 |
| Unintended system motion |
1 |
| Contamination during use |
1 |
| Defective Alarm |
1 |
| Alarm, failure of low flow |
1 |
| Not audible alarm |
1 |
| Alarm, failure of warning |
1 |
| Adaptor, failure of |
1 |
| Restricted flowrate |
1 |
| Emergency stop button or switch failure |
1 |
| False reading from device non-compliance |
1 |
| Total Device Problems |
1858 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
