MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-12 for ESOPHYX2 R2006 manufactured by Endogastric Solutions, Inc..
[51976182]
Patient Sequence No: 1, Text Type: N, H10
[51976183]
Doctor was performing a transoral incisionless fundoplication surgery. Doctor said a cable "broke on the device". Staff opened a second device. Surgery completed, and there was no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5871260 |
| MDR Report Key | 5871260 |
| Date Received | 2016-08-12 |
| Date of Report | 2016-08-03 |
| Date of Event | 2016-07-21 |
| Report Date | 2016-08-03 |
| Date Reported to FDA | 2016-08-03 |
| Date Reported to Mfgr | 2016-08-03 |
| Date Added to Maude | 2016-08-12 |
| 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 | 3 |
| Brand Name | ESOPHYX2 |
| Generic Name | ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) |
| Product Code | ODE |
| Date Received | 2016-08-12 |
| Model Number | R2006 |
| Catalog Number | R2006 |
| Lot Number | 402230 |
| Device Expiration Date | 2018-04-27 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 2016-08-12 |