MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-09 for ESOPHYX2 HD SYSTEM R2005 manufactured by Endogastric Solutions Inc..
[25227256]
Patient Sequence No: 1, Text Type: N, H10
[25227257]
Doctor performing transoral incision-less fundoplication. Esophyx2 hd device was in use, springs broke on the device making the fasteners unusable. A second esophyx2 hd was opened and doctor was able to complete the procedure. Company rep was in room at the time of malfunction. Manufacturer response for fastener delivery system, esophyx 2 hd (per site reporter): unknown, rep aware at time of surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5063646 |
| MDR Report Key | 5063646 |
| Date Received | 2015-09-09 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-08-28 |
| Report Date | 2015-09-02 |
| Date Reported to FDA | 2015-09-02 |
| Date Reported to Mfgr | 2015-09-02 |
| Date Added to Maude | 2015-09-09 |
| 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 HD SYSTEM |
| Generic Name | ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) |
| Product Code | ODE |
| Date Received | 2015-09-09 |
| Catalog Number | R2005 |
| Lot Number | 401977 |
| Device Expiration Date | 2017-04-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-09-09 |