MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-07 for ENTRIGUE ENTACT SEPTAL STAPLER * 601-00100 manufactured by Arthrocare Corporation.
[16224840]
When trying to fire the instrument, it malfunctioned and no staples were fired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3801910 |
| MDR Report Key | 3801910 |
| Date Received | 2014-05-07 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-05-06 |
| Report Date | 2014-05-07 |
| Date Reported to FDA | 2014-05-07 |
| Date Reported to Mfgr | 2014-05-09 |
| Date Added to Maude | 2014-05-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTRIGUE ENTACT SEPTAL STAPLER |
| Generic Name | SEPTAL STAPLER/ABSORBABLE STAPLES |
| Product Code | OLL |
| Date Received | 2014-05-07 |
| Model Number | * |
| Catalog Number | 601-00100 |
| Lot Number | 401012 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORPORATION |
| Manufacturer Address | 12672 SILICON DRIVE SUITE 150 SAN ANTONIO TX 78249 US 78249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-07 |