MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-08-20 for ENTACT SEPTAL STAPLER, 3-PACK 601-00100 manufactured by Arthrocare Corporation.
[4899016]
It was reported that during a nasal procedure using an entact septal stapler, the stapler was not functioning properly and the staples were coming out after deployed. Two additional staplers were opened, however, these yielded the same results. The surgeon opted to complete the procedure using a competitive device. There were no significant delays or patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2014-00274 |
| MDR Report Key | 4062837 |
| Report Source | 01,06 |
| Date Received | 2014-08-20 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2014-07-24 |
| Device Manufacturer Date | 2013-12-11 |
| Date Added to Maude | 2014-09-10 |
| 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 | 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 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, 3-PACK |
| Generic Name | IMPLANTABLE STAPLER |
| Product Code | OLL |
| Date Received | 2014-08-20 |
| Catalog Number | 601-00100 |
| Lot Number | 310022 |
| Device Expiration Date | 2016-11-01 |
| 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. Other | 2014-08-20 |