MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-26 for ENTACT SEPTAL STAPLER, 3-PACK 601-00100 manufactured by Arthrocare Corp..
[51233729]
Patient Sequence No: 1, Text Type: N, H10
[51233730]
It was reported during a post operative visit following a septoplasty which involved the entact septal stapler, the surgeon noted that there was crusting on the staples which caused some obstruction. The surgeon debrided the crusting out. There were no additional patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[55337478]
Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. There are several factors that could contribute to the reported event. It is possible that an attempt was made to staple thick or hard tissue, placing the staple at the edge of cartilage, or an attempt to staple tissue in a constrained anatomical area which prevents the stapler arms from opening completely. The instructions for use for the device contains warning and precautionary measures regarding use of the device such as,? Placement of supporting sutures or other closure augmentation may be required to ensure closure integrity when excessive tension on the wound edge is or may be present.? Also, "possible adverse effects include but are not limited to wound complications including hematoma, site drainage, infection, toxic shock syndrome and other complications that are possible with any surgery. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2016-00173 |
| MDR Report Key | 5822708 |
| Date Received | 2016-07-26 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-06-20 |
| Date Mfgr Received | 2016-07-07 |
| Date Added to Maude | 2016-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 W WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTACT SEPTAL STAPLER, 3-PACK |
| Generic Name | SPLINT, INTRANASAL SEPTAL |
| Product Code | LYA |
| Date Received | 2016-07-26 |
| Catalog Number | 601-00100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-26 |