MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[75927681]
The device was available from the hospital for evaluation; an engineering device evaluation was performed on the returned product. The retractor control cable was found encumbered by the scope retainer band and the helix and centering needle were bent. The tissue mold was fully operational although some drag was noted when opening/closing the tissue mold. The drag was caused by the helical control cable being wedged in the tissue mold as the result of being encumbered by the scope retainer band. A review of the dhr indicates the materials and assembly process were to specifications and passed all final testing criteria. The root cause of the helical control cable caught in the scope retainer band could not be definitively determined. This is the second reported occurrence in 17,245 procedures (0. 012%). There is no reported patient injury; however, if the failure were to recur, it may require intervention to prevent serious injury.
Patient Sequence No: 1, Text Type: N, H10
[75927682]
The user reported the tissue mold would not open or close as expected. As a result, the user was unable to manipulate the tissue mold to properly position tissue. The initial device was uneventfully removed and the procedure was successfully completed with a secondary r2005 device. There is no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2017-00103 |
| MDR Report Key | 6586499 |
| Date Received | 2017-05-23 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-24 |
| Device Manufacturer Date | 2016-10-18 |
| Date Added to Maude | 2017-05-23 |
| 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 980525022 |
| Manufacturer Country | US |
| Manufacturer Postal | 980525022 |
| Manufacturer Phone | 4253079233 |
| Manufacturer G1 | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Street | 18109 NE 76TH STREET SUITE 100 |
| Manufacturer City | REDMOND WA 980525022 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 980525022 |
| 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 | 2017-05-23 |
| Returned To Mfg | 2017-05-02 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| Lot Number | 402355 |
| Device Expiration Date | 2018-10-18 |
| 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 | 2017-05-23 |