MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-13 for ESOPHYX 1111632 manufactured by Endogastric Solutions.
[70253383]
During the transoral incisionless fundoplication dr (b)(6) experienced a malfunction of the esophyx delivery device. The posterior side of the device was unable to be reloaded to fire another fastener. The anterior side was still functioning and the remaining fasteners were fired from it to complete the case. No apparent harm was caused to the patient. Diagnosis or reason for use: gerd. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068503 |
| MDR Report Key | 6410696 |
| Date Received | 2017-03-13 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-09-12 |
| Date Added to Maude | 2017-03-16 |
| 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 |
| 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 | 0 |
| Brand Name | ESOPHYX |
| Generic Name | ESOPHYX DELIVERY DEVICE |
| Product Code | ODE |
| Date Received | 2017-03-13 |
| Returned To Mfg | 2012-09-12 |
| Model Number | 1111632 |
| Lot Number | 402255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-13 |