| Device |
clip, implantable |
| Regulation Description |
Implantable clip. |
| Product Code | FZP |
| Regulation Number |
878.4300
|
|---|
| Device Class |
2
|
| Device Problems |
| Failure to form staple |
623 |
| Replace |
537 |
| Sticking |
232 |
| Mechanical jam |
180 |
| Malfunction |
169 |
| Difficult to open or close |
157 |
| Break |
152 |
| Component falling |
128 |
| Unintended ejection |
112 |
| Misfire |
108 |
| Detachment of device component |
93 |
| Difficult to remove |
92 |
| Device Issue |
86 |
| Failure to fire |
80 |
| Failure to deploy |
71 |
| Other (for use when an appropriate device code cannot be identified) |
71 |
| Failure to advance |
63 |
| Device, removal of (non-implant) |
48 |
| Device operates differently than expected |
47 |
| Clips, scissored |
43 |
| Leak |
37 |
| Unknown (for use when the device problem is not known) |
35 |
| Device inoperable |
34 |
| Dislodged or dislocated |
28 |
| Device maintenance issue |
27 |
| Loose |
25 |
| Slippage of device or device component |
23 |
| Failure to align |
23 |
| Close, difficult to |
16 |
| Tip breakage |
14 |
| Device Difficult to Setup or Prepare |
11 |
| No Information |
10 |
| Tear, rip or hole in device packaging |
10 |
| Defective item |
9 |
| Bent |
9 |
| Device or device fragments location unknown |
8 |
| Failure to disconnect |
8 |
| Failure to deliver |
7 |
| Fracture |
7 |
| Component(s), broken |
7 |
| Implant, removal of |
6 |
| Dislodged |
6 |
| Performance |
6 |
| Defective component |
5 |
| Physical resistance |
5 |
| Detachment of device or device component |
5 |
| Difficult to insert |
5 |
| Material separation |
5 |
| Difficult or delayed activation |
5 |
| Out-of-box failure |
5 |
| Difficult to deploy |
5 |
| Excessive Manipulation |
5 |
| Entrapment of device or device component |
4 |
| Tears, rips, holes in device, device material |
4 |
| Mechanical issue |
4 |
| Noise |
3 |
| Component missing |
3 |
| Failure to separate |
3 |
| Self-activation or keying |
3 |
| Difficult to position |
3 |
| Material twisted |
3 |
| Failure to Adhere or Bond |
3 |
| No code available |
3 |
| Twisting |
2 |
| Difficult to advance |
2 |
| Disconnection |
2 |
| Metal shedding debris |
2 |
| Blockage within device or device component |
2 |
| Positioning Issue |
2 |
| Migration of device or device component |
2 |
| Device, or device fragments remain in patient |
2 |
| Use of Device Issue |
2 |
| Material puncture |
2 |
| Premature deployment |
2 |
| Malposition of device |
2 |
| Loose or intermittent connection |
2 |
| Retraction problem |
2 |
| Hole in material |
2 |
| Improper or incorrect procedure or method |
2 |
| Dislocated |
1 |
| Material discolored |
1 |
| System fails to activate |
1 |
| Fluid leak |
1 |
| Low sensing threshold |
1 |
| Coiled |
1 |
| Device stops intermittently |
1 |
| Fitting problem |
1 |
| Device packaging compromised |
1 |
| Misshaped Lens (Warped, not round) |
1 |
| Patient-device incompatibility |
1 |
| Agglutinate, failure to |
1 |
| Delivery system failure |
1 |
| Difficult to open or remove packaging material |
1 |
| Resistance, loss of |
1 |
| Particulates |
1 |
| Device damaged prior to use |
1 |
| Suture line separation |
1 |
| Device-device incompatibility |
1 |
| Normal |
1 |
| Foreign material |
1 |
| Total Device Problems |
3592 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
1 |
2 |
0 |
1 |
0 |
1 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
