MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-19 for POWER CIRCULAR STAPLER (EEA) manufactured by Ethicon.
| Report Number | 8811608 |
| MDR Report Key | 8811608 |
| Date Received | 2019-07-19 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-05-24 |
| Date Facility Aware | 2019-05-30 |
| Report Date | 2019-06-10 |
| Date Reported to FDA | 2019-06-10 |
| Date Reported to Mfgr | 2019-06-10 |
| Date Added to Maude | 2019-07-22 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER CIRCULAR STAPLER (EEA) |
| Generic Name | STAPLER |
| Product Code | GAG |
| Date Received | 2019-07-19 |
| Returned To Mfg | 2019-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | 4545 CREEK ROAD CINCINNATI OH 45242 US 45242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-07-19 |