| Device |
instrument, ultrasonic surgical |
| Product Code | LFL |
| Device Class |
Unclassified
|
| Device Problems |
| Replace |
987 |
| Device displays error message |
710 |
| Break |
348 |
| Device inoperable |
321 |
| Detachment of device component |
300 |
| Device Issue |
264 |
| Component falling |
194 |
| System fails to activate |
138 |
| Device operates differently than expected |
85 |
| Device, removal of (non-implant) |
75 |
| Tip breakage |
59 |
| Component(s), broken |
52 |
| Alarm, audible |
48 |
| Melted |
45 |
| Noise |
43 |
| Loose |
43 |
| Mechanical issue |
39 |
| Device or device fragments location unknown |
34 |
| Sticking |
31 |
| Crack |
29 |
| Failure, intermittent |
28 |
| Slippage of device or device component |
27 |
| Failure to cut |
27 |
| Overheating of device or device component |
27 |
| Unknown (for use when the device problem is not known) |
27 |
| Difficult or delayed activation |
25 |
| Smoking |
25 |
| Difficult to open or close |
23 |
| Repair |
22 |
| Detachment of device or device component |
20 |
| No Information |
19 |
| Malfunction |
15 |
| Failure to power-up |
15 |
| Mechanical jam |
14 |
| Defective component |
12 |
| Burn of device or device component |
11 |
| Agglutinate, failure to |
11 |
| Self-activation or keying |
10 |
| Component missing |
10 |
| Device stops intermittently |
10 |
| Material separation |
8 |
| Device damaged prior to use |
8 |
| Peeled |
8 |
| Prompts will not clear |
7 |
| Application interface becomes non-functional or program exits abnormally |
7 |
| Component(s), overheating of |
7 |
| Device alarm system issue |
7 |
| Temperature issue |
6 |
| Failure to deliver energy |
6 |
| Device emits odor |
5 |
| Device remains activated |
5 |
| Disconnection |
5 |
| Defective item |
5 |
| Material fragmentation |
5 |
| Tears, rips, holes in device, device material |
4 |
| Improper or incorrect procedure or method |
4 |
| Foreign material |
4 |
| No Known Device Problem |
4 |
| Failure to align |
4 |
| Dislodged or dislocated |
4 |
| Failure of device to self-test |
4 |
| Handpiece break |
4 |
| Normal |
4 |
| Connection error |
4 |
| Difficult to remove |
4 |
| Bent |
3 |
| Heat |
3 |
| Split |
3 |
| Error or warning message, failure to produce |
3 |
| Flaked |
3 |
| No display or display failure |
3 |
| Loss of power |
3 |
| Tear, rip or hole in device packaging |
3 |
| High impedance |
3 |
| Calibration error |
3 |
| Device, or device fragments remain in patient |
3 |
| Other (for use when an appropriate device code cannot be identified) |
3 |
| Material integrity issue |
2 |
| Component(s), worn |
2 |
| Out-of-box failure |
2 |
| Cut in material |
2 |
| Material deformation |
2 |
| Electrical issue |
2 |
| Material discolored |
2 |
| Seal, defective |
2 |
| Failure to fire |
2 |
| Connection issue |
2 |
| Material disintegration |
2 |
| Sharp/jagged/rough/etched/scratched |
2 |
| Blockage within device or device component |
2 |
| Close, difficult to |
2 |
| Torn material |
2 |
| Torqued |
2 |
| Unintended collision |
2 |
| Failure to Adhere or Bond |
2 |
| Incorrect or inadequate test results |
2 |
| Device maintenance issue |
2 |
| Failure to form staple |
2 |
| Coagulation in device or device ingredient |
2 |
| Locking mechanism failure |
2 |
| Total Device Problems |
4438 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
1 |
1 |
4 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
