MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-14 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[36476624]
Although there was no indication of an injury to the patient or a manufacturing process issue, this failure mode is now being reported due to previously establishing that if this malfunction were to reoccur, a serious injury may occur.
Patient Sequence No: 1, Text Type: N, H10
[36476625]
Surgeon was in the initial process of inserting device down the patient's esophagus. The device was in the proximal esophagus when the surgeon experienced some resistance in progressing down the esophagus. The physician extracted the device. Following removal it was noticed the elastic band which holds the distal tip of the endoscope in place against the distal tip of the device during insertion was broken. There were no adverse patient effects and a second device was opened and used to successfully complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2015-00094 |
| MDR Report Key | 5368436 |
| Date Received | 2016-01-14 |
| Date of Report | 2016-01-11 |
| Date of Event | 2015-12-16 |
| Date Mfgr Received | 2015-12-16 |
| Device Manufacturer Date | 2015-08-17 |
| Date Added to Maude | 2016-01-14 |
| 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 | ENDOGATRIC 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 | 2016-01-14 |
| Returned To Mfg | 2015-12-31 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| Lot Number | 402053 |
| Device Expiration Date | 2017-08-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-01-14 |