MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-15 for ESOPHYX Z C02162-01 R2006 manufactured by Endogastric Solutions, Inc..
[40401436]
Procedure was performed successfully and the device was discarded per hospital policy. There was no allegation of a product malfunction.
Patient Sequence No: 1, Text Type: N, H10
[40401437]
A successful tif procedure was performed on (b)(6) 2016 and the device was disposed of per hospital policy. Two days later the physician reported to the egs sales representative the patient was readmitted with chest pain. It was postulated a small leak developed during the procedure, allowing procedure insufflation gas into the mediastinum. A ct scan supported this as it did not show any any pleural effusion or sub-diaphragm air and indicated any leak had resolved on its own. Experience has shown the procedure gas used will absorb after two to three days in most cases. The physician took a position of expectant surveillance with no intervention. A few days later the physician reported the patient was doing well. The gas had absorbed and the patient was discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2016-00096 |
| MDR Report Key | 5502996 |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-03-03 |
| Date Added to Maude | 2016-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. JAMES BROOKS |
| Manufacturer Street | 18109 NE 76TH STREET SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4253079233 |
| Manufacturer G1 | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Street | 18109 NE 76TH STREET SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ESOPHYX Z |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2016-03-15 |
| Model Number | C02162-01 |
| Catalog Number | R2006 |
| Lot Number | NOT REPORTED |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Address | 18109 NE 76TH STREET SUITE 100 REDMOND WA 980525022 US 980525022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-03-15 |