MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for ENTACT SEPTAL STAPLER, 1-PACK 601-00100S manufactured by Arthrocare Corporation.
[115778999]
Patient Sequence No: 1, Text Type: N, H10
[115779000]
It was reported that the first stapler failed to dispense any sutures, back up device was used and sutures did not stay in the septum. A delay greater than 30 minutes was reported. No patient injuries were reported. Local anesthesia was used. A backup was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2018-00395 |
| MDR Report Key | 7736259 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-05-25 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2017-10-23 |
| Date Added to Maude | 2018-07-31 |
| 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 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | ARTHROCARE CORPORATION |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| 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 | 0 |
| Brand Name | ENTACT SEPTAL STAPLER, 1-PACK |
| Generic Name | SEPTAL STAPLER/ABSORBABLE STAPLES |
| Product Code | OLL |
| Date Received | 2018-07-31 |
| Model Number | 601-00100S |
| Catalog Number | 601-00100S |
| Lot Number | VN11446 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORPORATION |
| Manufacturer Address | 7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |