MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-06 for ESOPHYX Z+ R2007 manufactured by Endogastric Solutions, Inc..
| Report Number | 8864069 |
| MDR Report Key | 8864069 |
| Date Received | 2019-08-06 |
| Date of Report | 2019-07-27 |
| Date of Event | 2019-03-21 |
| Report Date | 2019-07-27 |
| Date Reported to FDA | 2019-07-27 |
| Date Reported to Mfgr | 2019-08-06 |
| Date Added to Maude | 2019-08-06 |
| 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 | ESOPHYX Z+ |
| Generic Name | ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) |
| Product Code | ODE |
| Date Received | 2019-08-06 |
| Returned To Mfg | 2019-04-23 |
| Model Number | R2007 |
| Catalog Number | R2007 |
| Lot Number | 402656 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Address | 18109 NE 76TH ST SUITE 100 REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-06 |