MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-05-01 for ENTACT SEPTAL STAPLER 601-00100 manufactured by Arthrocare Corporation.
[21803947]
It was reported via a voluntary medwatch that during a septoplasty procedure using the entact septal stapler, the stapler allegedly tore the patient's nasal septum. This incident required the surgeon to repair and reconstruct the septum. No additional details were provided regarding the event or the patient's recovery progress; however, no further complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2014-00123 |
| MDR Report Key | 3799199 |
| Report Source | 00 |
| Date Received | 2014-05-01 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-02-11 |
| Date Mfgr Received | 2014-03-31 |
| Device Manufacturer Date | 2013-10-29 |
| Date Added to Maude | 2014-05-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WENDY LAIRD |
| Manufacturer Street | 7000 W WILLIAM CANNON DR BLDG 1 |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585933 |
| Manufacturer G1 | ARTHROCARE COSTA RICA |
| Manufacturer Street | 7000 W WILLIAM CANNON DR |
| Manufacturer City | LA AURORA, HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTACT SEPTAL STAPLER |
| Generic Name | IMPLANTABLE STAPLER |
| Product Code | OLL |
| Date Received | 2014-05-01 |
| Catalog Number | 601-00100 |
| Lot Number | 310005 |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORPORATION |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-01 |