MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-22 for ENTACT SEPTAL STAPLER, 3-PACK 601-00100 manufactured by Arthrocare Corp..
[95851386]
Patient Sequence No: 1, Text Type: N, H10
[95851387]
It was reported that while using an entact stapler (601-00100) on monday and the tip of the stapler broke. They said it was just a piece of plastic that broke off when they went to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2017-00439 |
| MDR Report Key | 7142029 |
| Date Received | 2017-12-22 |
| Date of Report | 2018-03-01 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2017-09-21 |
| Date Added to Maude | 2017-12-22 |
| 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 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 | 0 |
| Brand Name | ENTACT SEPTAL STAPLER, 3-PACK |
| Generic Name | SEPTAL STAPLER/ABSORBABLE STAPLES |
| Product Code | OLL |
| Date Received | 2017-12-22 |
| Returned To Mfg | 2018-01-16 |
| Model Number | 601-00100 |
| Catalog Number | 601-00100 |
| Lot Number | 708018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-12-22 |