MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-05 for ETHICON ECHELON FLEX POWERED PLUS STAPLER 60 PCEE60A manufactured by Ethicon, Assembled In Mexico Made In Puerto Rico.
| Report Number | 8874614 |
| MDR Report Key | 8874614 |
| Date Received | 2019-08-05 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-06-06 |
| Date Facility Aware | 2019-06-06 |
| Report Date | 2019-08-06 |
| Date Reported to FDA | 2019-08-01 |
| Date Added to Maude | 2019-08-08 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ETHICON ECHELON FLEX POWERED PLUS STAPLER |
| Generic Name | ETHICON ECHELON FLEX POWERED PLUS STAPLER |
| Product Code | GAG |
| Date Received | 2019-08-05 |
| Model Number | 60 PCEE60A |
| Catalog Number | 60 PCEE60A |
| Lot Number | T9262Z |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, ASSEMBLED IN MEXICO MADE IN PUERTO RICO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-05 |