MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-13 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[75318870]
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 looped and captured in the tissue mold and the helix coil was elongated. 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 failure could not be determined. (b)(4). 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
[75318871]
After deploying two sets of fasteners in one location and moving to a second location, the user reported the helical retractor "felt loose" and "didn't feel right" and made an unsuccessful attempt to engage tissue. Upon visual inspection by the user, it was observed the helix was protruding 90-degrees from the distal end of the tissue mold. An attempt to straighten the helix using the endoscope was unsuccessful. The user subsequently attempted to straighten the helix using the endoscope grasper but was unsuccessful. After the unsuccessful attempts, the endoscope grasper was used to cover the helix to safely remove the device. A secondary r2005 device was used to successfully complete the procedure. There is no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2017-00102 |
| MDR Report Key | 6566068 |
| Date Received | 2017-05-13 |
| Date of Report | 2017-05-13 |
| Date of Event | 2017-04-14 |
| Date Mfgr Received | 2017-04-14 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2017-05-13 |
| 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 | 2017-05-13 |
| Returned To Mfg | 2017-04-28 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| Lot Number | 402400 |
| Device Expiration Date | 2019-01-12 |
| 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 | 1. Required No Informationntervention | 2017-05-13 |