MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-05 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[51344184]
The device was discarded per hospital policy.
Patient Sequence No: 1, Text Type: N, H10
[51344185]
The customer reported a tif procedure was initiated with 6 fasteners successfully deployed in the ge junction. Loss of insufflation was noted. Omentum tissue was observed endoscopically and an exploratory laparotomy procedure was initiated to determine cause of loss of insufflation. A perforation in the greater curvature was found and resolved. Physician speculates the helical tissue retractor either perforated or tore the tissue during tissue retraction. It was also reported that the patients stomach tissue appeared thin and may have contributed to the perforation. Patient was admitted to the hospital (b)(6) 2016 and was discharged (b)(6) 2016. The patient was seen (b)(6) 2016 by the physician and is reported to be doing very well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2016-00099 |
| MDR Report Key | 5852023 |
| Date Received | 2016-08-05 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-07-07 |
| Date Mfgr Received | 2016-07-22 |
| Date Added to Maude | 2016-08-05 |
| 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 | 2016-08-05 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| Lot Number | UNKNOWN |
| 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 | 2016-08-05 |