| Device |
bronchoscope (flexible or rigid) |
| Regulation Description |
Bronchoscope (flexible or rigid) and accessories. |
| Product Code | EOQ |
| Regulation Number |
874.4680
|
|---|
| Device Class |
2
|
| Device Problems |
| Retraction problem |
73 |
| Bent |
44 |
| Other (for use when an appropriate device code cannot be identified) |
26 |
| Break |
19 |
| Kinked |
17 |
| Vacuum, loss of |
17 |
| No display or display failure |
16 |
| Detachment of device component |
15 |
| Leak |
13 |
| Difficult to remove |
12 |
| Material puncture |
11 |
| Suction issue |
10 |
| Failure to advance |
9 |
| Detachment of device or device component |
9 |
| No code available |
9 |
| Device Cleaning Issue |
9 |
| No Known Device Problem |
8 |
| Disinfection or Sterilization Issue at User Location |
7 |
| No Information |
6 |
| Component(s), broken |
6 |
| Crack |
5 |
| Needle, unsheathed |
5 |
| Peeled |
4 |
| Torn material |
4 |
| Device inoperable |
4 |
| Aspiration, incomplete |
3 |
| Unknown (for use when the device problem is not known) |
3 |
| Bacterial contamination of device |
3 |
| Wire(s), breakage of |
3 |
| Mechanical jam |
3 |
| Material separation |
3 |
| Loose or intermittent connection |
3 |
| Fracture |
3 |
| Material fragmentation |
3 |
| Flaked |
2 |
| Difficult to fold or unfold |
2 |
| Failure to disinfect |
2 |
| Dislodged |
2 |
| Foreign material present in device |
2 |
| Dislodged or dislocated |
2 |
| Fungus in device environment |
2 |
| Device damaged prior to use |
2 |
| Defective component |
1 |
| Tube(s), defective |
1 |
| Solder joint failure |
1 |
| Fitting problem |
1 |
| Device Issue |
1 |
| Dull |
1 |
| Malfunction |
1 |
| Obstruction within device |
1 |
| Cut in material |
1 |
| Flare or flash |
1 |
| Device operates differently than expected |
1 |
| Defective item |
1 |
| Device or device fragments location unknown |
1 |
| Close, difficult to |
1 |
| Buckled material |
1 |
| Maintenance does not comply to manufacturers recommendations |
1 |
| Material Protrusion |
1 |
| Burn of device or device component |
1 |
| Foreign material |
1 |
| Image resolution poor |
1 |
| Entrapment of device or device component |
1 |
| Device expiration issue |
1 |
| Fiberoptic break/separation |
1 |
| Unintended ejection |
1 |
| Loose |
1 |
| Mechanical issue |
1 |
| Misassembled |
1 |
| Misfocusing |
1 |
| Needle, separation |
1 |
| Source, detachment from |
1 |
| Syringe, defective |
1 |
| Tears, rips, holes in device, device material |
1 |
| Performance |
1 |
| Occlusion within device |
1 |
| Total Device Problems |
435 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
