| Device |
ligator, esophageal |
| Regulation Description |
Hemorrhoidal ligator. |
| Product Code | MND |
| Regulation Number |
876.4400
|
|---|
| Device Class |
2
|
| Device Problems |
| Failure to separate |
616 |
| Failure to deploy |
596 |
| Premature deployment |
378 |
| Failure to advance |
290 |
| Failure to disconnect |
270 |
| Other (for use when an appropriate device code cannot be identified) |
250 |
| Detachment of device component |
178 |
| Material separation |
170 |
| No code available |
134 |
| Difficult to deploy |
108 |
| Break |
104 |
| Misfire |
100 |
| Bent |
92 |
| Fracture |
84 |
| Device maintenance issue |
76 |
| Migration of device or device component |
57 |
| Component(s), broken |
46 |
| Kinked |
22 |
| Close, difficult to |
22 |
| No Known Device Problem |
21 |
| Mechanical issue |
20 |
| Improper or incorrect procedure or method |
17 |
| Difficult to open or close |
17 |
| Device operates differently than expected |
15 |
| Deployment issue |
12 |
| Failure to fire |
11 |
| Component missing |
11 |
| User used incorrect product for intended use |
11 |
| Difficult to remove |
10 |
| Difficult to position |
10 |
| Device Issue |
10 |
| Device inoperable |
9 |
| Failure to Adhere or Bond |
9 |
| Suction issue |
8 |
| Unknown (for use when the device problem is not known) |
8 |
| Excessive Manipulation |
8 |
| Malposition of device |
8 |
| Detachment of device or device component |
7 |
| Device, or device fragments remain in patient |
7 |
| Device-device incompatibility |
6 |
| No Information |
6 |
| Mechanical jam |
5 |
| Dislodged or dislocated |
5 |
| Fitting problem |
5 |
| Shelf life exceeded |
5 |
| Failure to deliver |
5 |
| Wire(s), breakage of |
5 |
| Dislodged |
5 |
| Entrapment of device or device component |
5 |
| Device expiration issue |
5 |
| Component falling |
4 |
| Difficult to insert |
4 |
| Defective item |
4 |
| Cut in material |
3 |
| Source, detachment from |
3 |
| Vacuum, loss of |
3 |
| Device damaged prior to use |
3 |
| Misassembled |
3 |
| Normal |
3 |
| Torn material |
3 |
| Incompatibility problem |
2 |
| Device, removal of (non-implant) |
2 |
| Lens (IOL), defective, problem not specified |
2 |
| Loose |
2 |
| Decrease in suction |
2 |
| Accessory incompatible |
2 |
| Defective component |
2 |
| Sticking |
2 |
| Stretched |
2 |
| Suture line separation |
2 |
| Tears, rips, holes in device, device material |
2 |
| Slippage of device or device component |
2 |
| pH, low |
2 |
| Failure to align |
1 |
| Inaccurate delivery |
1 |
| Malfunction |
1 |
| Device or device fragments location unknown |
1 |
| Physical resistance |
1 |
| Increased sensitivity |
1 |
| Split |
1 |
| Unstable |
1 |
| Twisting |
1 |
| Seal, defective |
1 |
| Abnormal |
1 |
| Loss of or failure to bond |
1 |
| Cautery |
1 |
| Deflation issue |
1 |
| Fluid leak |
1 |
| Foreign material |
1 |
| Inability to irrigate |
1 |
| Material fragmentation |
1 |
| Handpiece break |
1 |
| Replace |
1 |
| Retraction problem |
1 |
| Material puncture |
1 |
| Component or accessory incompatibility |
1 |
| Device misassembled during manufacturing or shipping |
1 |
| Material Protrusion |
1 |
| Material twisted |
1 |
| Difficult to advance |
1 |
| Total Device Problems |
3965 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2016 |
2017 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
