MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-03-14 for ENTACT SEPTAL STAPLER 601-00100 manufactured by Arthrocare Corporation.
[19921859]
It was reported that during a sinus procedure using the entact septal stapler, the staples neglected to grip the septum properly and was suctioned. The surgeon opted to complete the procedure using a competitive suturing 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 | 3006524618-2014-00077 |
| MDR Report Key | 3938033 |
| Report Source | 07 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-02-13 |
| Date of Event | 2014-02-05 |
| Date Mfgr Received | 2014-02-13 |
| Device Manufacturer Date | 2013-12-11 |
| Date Added to Maude | 2014-07-28 |
| 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 787350000 |
| Manufacturer Country | US |
| Manufacturer Postal | 787350000 |
| Manufacturer Phone | 5123585933 |
| Manufacturer G1 | ARTHROCARE COSTA RICA |
| Manufacturer City | LA AURORA, HEREDIA |
| 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 | 2014-03-14 |
| 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 | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORPORATION |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-14 |