MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-11 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[49235006]
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
[49235007]
The customer reported that a successful tif and hiatal hernia procedure was completed. The day after the procedure, the patient returned to the hospital with unspecified symptoms. Indication of low hematocrit anemia and hematochezia was noted and the patient was given an unspecified amount of blood. An egd procedure was performed and blood was found in the stomach along with a hematoma with extravasated tissue. The extravasated tissue was successfully cauterized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2016-00098 |
| MDR Report Key | 5784375 |
| Date Received | 2016-07-11 |
| Date of Report | 2016-07-11 |
| Date of Event | 2016-07-05 |
| Date Mfgr Received | 2016-07-07 |
| Date Added to Maude | 2016-07-11 |
| 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 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 | ESOPHYX2 HD |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2016-07-11 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| Lot Number | 402163 |
| Device Expiration Date | 2018-01-25 |
| 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. Required No Informationntervention | 2016-07-11 |