MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-06-11 for ESOPHYX2 R2000 manufactured by Endogastric Solutions, Inc..
[110703476]
This serious adverse event was discovered during a literature review on 06/01/2018. In a follow-up conversation, the physician stated he "... Pushed the endoscope into the esophageal wall thinking [the endoscope] was passing through the hiatus. I was not visualizing the image at the time". The physician did not allege a device malfunction caused or contributed to the adverse event.
Patient Sequence No: 1, Text Type: N, H10
[110703477]
An esophageal perforation occurred during the introduction of the esophyx device. The perforation was treated with endoclips and the procedure was uneventfully aborted. The patient was hospitalized and a nissen fundoplication was performed the day after. The patient was discharged two days later without further complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2018-00111 |
| MDR Report Key | 7589610 |
| Report Source | LITERATURE |
| Date Received | 2018-06-11 |
| Date of Report | 2018-06-11 |
| Date of Event | 2010-06-02 |
| Date Mfgr Received | 2018-06-01 |
| Device Manufacturer Date | 2017-02-28 |
| Date Added to Maude | 2018-06-11 |
| 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 ST 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 ST 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 | 3 |
| Brand Name | ESOPHYX2 |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2018-06-11 |
| Catalog Number | R2000 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-11 |