MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-08 for ESOPHYX2 HD R2005 manufactured by Endogastric Solutions, Inc..
[107606105]
Patient Sequence No: 1, Text Type: N, H10
[107606106]
Risk: pt scheduled for esophagogastroduodenoscopy (egd) with transoral incisionless fundoplication (tif). Pt arrived in pre-op at 0920. Pt brought in procedure room at 1233. Procedure started at 1256 and ended at 1731. First device of tif malfunctioned and second device also malfunctioned. Procedure aborted causing perforation. Doctor overstitched perforation site and placed an esophageal stent. Pt sent to main post anesthesia care unit (pacu) and then admitted. Both devices were taken with reps from endogastric solution to send to their quality control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7494268 |
| MDR Report Key | 7494268 |
| Date Received | 2018-05-08 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-03-29 |
| Report Date | 2018-04-13 |
| Date Reported to FDA | 2018-04-13 |
| Date Reported to Mfgr | 2018-04-13 |
| Date Added to Maude | 2018-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHYX2 HD |
| Generic Name | ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD) |
| Product Code | ODE |
| Date Received | 2018-05-08 |
| Model Number | R2005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Address | 18109 NE 76TH ST. STE 100 REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-08 |