MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[46167945]
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
[46167946]
A tif procedure was performed and the procedure was completed successfully. The device was discarded per hospital policy. The patient was discharged the next day with no issues. Three days later the patient was readmitted with chest pain, became febrile, developed epigastric pain and had slight alterations of her vitals. A gastrografin swallow, showed a leak at the distal/posterior part of the esophagus. The ct scan showed a small perforation of 2 mm diameter. The patient had a laparoscopic procedure, during which, the perforation was repaired and a small mediastinal abscess that started to develop, was successfully drained. Two days later a bilateral pleural effusion was diagnosed and a drain tube was placed and was effective. The patient fully recovered. The physician speculated the patient may have pulled a fastener loose due to strain or retching after initial discharge from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2016-00097 |
| MDR Report Key | 5686321 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-05-27 |
| Date of Event | 2016-04-28 |
| Date Mfgr Received | 2016-04-28 |
| Date Added to Maude | 2016-05-27 |
| 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 | 2016-05-27 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| Lot Number | 402099 |
| Device Expiration Date | 2017-12-31 |
| 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; 2. Required No Informationntervention | 2016-05-27 |