MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-15 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[40367956]
Procedure was performed successfully and the device was discarded per hospital policy. There was no allegation of a product malfunction. Bleeding was not identified until patient was back in room. Post operative scans and exam did not reveal the bleeding site, which resolved on its own. The physician reported the patient was doing well and was released on the fourth day.
Patient Sequence No: 1, Text Type: N, H10
[40367957]
The company sales rep reported that in an email correspondence with the physician, it was mentioned the tif patient, who would normally spend one night in the hospital following the procedure, had spent several more days due to bleeding. There was no allegation of device malfunction. The device was discarded by the hospital after the successful procedure. Bleeding was identified after the patient was back in her room. Post procedure exams/testing showed no further bleeding and no specific bleeder site was found. The bleeding resolved on its own.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2016-00095 |
| MDR Report Key | 5501638 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-02-26 |
| 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 | 3 |
| Brand Name | ESOPHYX2 HD |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2016-03-15 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| 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 |