MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for ESOPHYX Z REF # R2006 manufactured by Endogastric Solutions.
[83648488]
Pt scheduled for an egd with transoral incisionless fundoplication with esophyx z device. During procedure, md inspected esophyx z device prior to inserting into pt's mouth. Once in esophagus, metal spike/needle on end of device would not retract properly. When device removed from pt's esophagus and mouth, esophageal tears noted on egd scope from device. Md visualized and decided not to proceed further with procedure. Device taken from the field, and the esophyx device rep called by central sterile and md. Device cleaned with caution and taken to central sterile to be returned to company and notified of adverse event. Pt extubated without problem. Md ordered upper gi which revealed esophageal tear, but no esophageal leak. Pt discharged to home same day. No add'l procedures required to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071773 |
| MDR Report Key | 6816519 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-08-10 |
| Date Added to Maude | 2017-08-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ESOPHYX Z |
| Generic Name | ESOPHYX Z |
| Product Code | ODE |
| Date Received | 2017-08-24 |
| Model Number | REF # R2006 |
| Lot Number | 402459 |
| Device Expiration Date | 2019-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS |
| Manufacturer Address | 18109 NE 76TH STREET STE 100 REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-24 |