| Device |
forceps, biopsy, non-electric |
| Regulation Description |
Gastroenterology-urology biopsy instrument. |
| Product Code | FCL |
| Regulation Number |
876.1075
|
|---|
| Device Class |
1
|
| Device Problems |
| Bent |
266 |
| No code available |
185 |
| Other (for use when an appropriate device code cannot be identified) |
160 |
| Break |
140 |
| No Known Device Problem |
113 |
| Detachment of device component |
71 |
| Close, difficult to |
60 |
| Difficult to remove |
50 |
| Wire(s), breakage of |
48 |
| Fracture |
42 |
| Normal |
22 |
| Unknown (for use when the device problem is not known) |
21 |
| Material Protrusion |
21 |
| Device damaged prior to use |
19 |
| Mechanical jam |
17 |
| Component(s), broken |
17 |
| Mechanical issue |
16 |
| Device operates differently than expected |
12 |
| Difficult to insert |
10 |
| Electrical issue |
8 |
| Difficult to open or close |
8 |
| No Information |
8 |
| Component missing |
7 |
| Retraction problem |
7 |
| Device inoperable |
7 |
| Failure to advance |
7 |
| Device, or device fragments remain in patient |
7 |
| Source, detachment from |
6 |
| Device or device fragments location unknown |
6 |
| Failure to cut |
5 |
| Packaging issue |
5 |
| Kinked |
5 |
| Dull |
5 |
| Foreign material |
4 |
| Human-Device Interface Issue |
4 |
| Defective component |
4 |
| Physical resistance |
3 |
| Entrapment of device or device component |
3 |
| Twisting |
2 |
| Loose or intermittent connection |
2 |
| Unsealed device packaging |
2 |
| Tear, rip or hole in device packaging |
2 |
| Arcing |
2 |
| Foreign material present in device |
2 |
| Fitting problem |
2 |
| Loose |
2 |
| Defective item |
2 |
| Detachment of device or device component |
2 |
| Material perforation |
2 |
| Heat, failure to |
2 |
| Collapse |
1 |
| Inadequate user interface |
1 |
| Split |
1 |
| Balloon rupture |
1 |
| Needle, separation |
1 |
| Contamination during use |
1 |
| Tip breakage |
1 |
| Incorrect device or component shipped |
1 |
| Failure to obtain samples |
1 |
| Failure to sterilize |
1 |
| Out-of-box failure |
1 |
| Lens, disc |
1 |
| Device Issue |
1 |
| Needle, dull |
1 |
| Residue after decontamination |
1 |
| Material frayed |
1 |
| Burn of device or device component |
1 |
| Difficult to deploy |
1 |
| Disconnection |
1 |
| Device markings issue |
1 |
| Scratched material |
1 |
| Total Device Problems |
1444 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
