MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-15 for ARCUS STAPLE SYSTEM ARC-1310K manufactured by Nextremity Solutions.
| Report Number | 3009540749-2020-00006 |
| MDR Report Key | 9592632 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-15 |
| Date of Report | 2019-01-15 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-15 |
| 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 | ELISE FOX |
| Manufacturer Street | 210 NORTH BUFFALO STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| Manufacturer Phone | 5743762062 |
| Manufacturer G1 | NEXTREMITY SOLUTIONS |
| Manufacturer Street | 210 NORTH BUFFALO STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCUS STAPLE SYSTEM |
| Generic Name | STAPLE |
| Product Code | JDR |
| Date Received | 2020-01-15 |
| Model Number | ARC-1310K |
| Lot Number | 168525417A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEXTREMITY SOLUTIONS |
| Manufacturer Address | 210 NORTH BUFFALO STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |