MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for ETHICON manufactured by Ethicon Endo-surgery Llc.
[71887022]
Ethicon stapler with reload locked up while in use. Ethicon representative was available to assist surgeon in releasing stapler and removal of the load. Replacement device was made available. No adverse event to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068892 |
| MDR Report Key | 6459777 |
| Date Received | 2017-04-03 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-22 |
| Date Added to Maude | 2017-04-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 |
| Generic Name | ECHELON FLEX POWERED PLUS STAPLER |
| Product Code | PLE |
| Date Received | 2017-04-03 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY LLC |
| Manufacturer Address | GUAYNABO PR 00969 US 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-03 |