MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for ESOPHYX2 R2006 manufactured by Endogastric Solutions.
[91812735]
Surgeon concerned that covidien eea stapler not functioning properly. Concern initiated after anastomosis completed but not able to identify 2 distinctive tissue donuts. Only the proxima donut was visualized, the distal donut could not be located. Surgeon had to re-anastomosis after this realization and could not attain original surgical goal of colostomy take down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073199 |
| MDR Report Key | 7013592 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-09-26 |
| Date Added to Maude | 2017-11-09 |
| 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 | ESOPHYX2 |
| Generic Name | ENDOSCOPIC SUTURE |
| Product Code | ODE |
| Date Received | 2017-11-09 |
| Returned To Mfg | 2017-10-30 |
| Model Number | R2006 |
| Lot Number | 402459 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS |
| Brand Name | EEA STAPLER |
| Generic Name | STAPLER |
| Product Code | GDG |
| Date Received | 2017-11-09 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-09 |