| Device |
snare, flexible |
| Regulation Description |
Endoscopic electrosurgical unit and accessories. |
| Product Code | FDI |
| Regulation Number |
876.4300
|
|---|
| Device Class |
2
|
| Device Problems |
| Detachment of device component |
132 |
| Break |
110 |
| Other (for use when an appropriate device code cannot be identified) |
87 |
| Failure to deliver energy |
67 |
| Component(s), broken |
58 |
| Failure to cut |
56 |
| Wire(s), breakage of |
44 |
| Retraction problem |
33 |
| Bent |
26 |
| Cautery |
25 |
| Electrical issue |
24 |
| No code available |
21 |
| Entrapment of device or device component |
17 |
| Melted |
16 |
| Kinked |
14 |
| Device damaged prior to use |
11 |
| Split |
11 |
| Close, difficult to |
10 |
| Failure to advance |
8 |
| Unknown (for use when the device problem is not known) |
8 |
| Device inoperable |
8 |
| Failure to align |
7 |
| Torn material |
7 |
| Spark |
6 |
| Difficult to remove |
6 |
| Fracture |
6 |
| Balloon rupture |
5 |
| Burn of device or device component |
5 |
| No Known Device Problem |
5 |
| No Information |
5 |
| Defective item |
4 |
| Material frayed |
4 |
| Twisting |
4 |
| Normal |
4 |
| Mechanical issue |
4 |
| Device Issue |
3 |
| Handpiece break |
3 |
| Inflation issue |
3 |
| Knotted |
2 |
| Heat, failure to |
2 |
| Insufficient heating |
2 |
| Device expiration issue |
2 |
| Failure to conduct |
2 |
| Crack |
2 |
| Malfunction |
2 |
| Component missing |
2 |
| Shock, electrical |
2 |
| Loose or intermittent connection |
2 |
| Loose |
2 |
| Material separation |
2 |
| Unsealed device packaging |
2 |
| Tears, rips, holes in device, device material |
2 |
| Arcing |
2 |
| Connection issue |
2 |
| Detachment of device or device component |
2 |
| Difficult to advance |
1 |
| Difficult to open or close |
1 |
| Extrusion |
1 |
| Output issue |
1 |
| Device, removal of (non-implant) |
1 |
| Tip breakage |
1 |
| Performance |
1 |
| Device, or device fragments remain in patient |
1 |
| Shaft break |
1 |
| Source, detachment from |
1 |
| Sterility |
1 |
| Stretched |
1 |
| Device maintenance issue |
1 |
| Output energy incorrect |
1 |
| Overheating of device or device component |
1 |
| Seal, defective |
1 |
| Tear, rip or hole in device packaging |
1 |
| Unit inactivated |
1 |
| Material perforation |
1 |
| Unraveled material |
1 |
| Metal shedding debris |
1 |
| Noise |
1 |
| Application interface becomes non-functional or program exits abnormally |
1 |
| Difficult to deploy |
1 |
| Disassembly |
1 |
| Disconnection |
1 |
| Dislodged |
1 |
| Connection error |
1 |
| Contamination during use |
1 |
| Component incompatible |
1 |
| Blockage within device or device component |
1 |
| Charred |
1 |
| Foreign material |
1 |
| Material fragmentation |
1 |
| Electrode(s), failure of |
1 |
| Energy output to patient tissue incorrect |
1 |
| Heat |
1 |
| Leak |
1 |
| Intraprocedure, fire or flash during |
1 |
| Total Device Problems |
940 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
