MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-08 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[97731799]
The device was available from the hospital for evaluation; an engineering device evaluation was performed on the returned product. The helical retractor control (retractor control knob, retractor system inner slide tube and a portion of the retractor drive cable) were confirmed to be separated from the device. There was evidence the retractor drive cable hockled prior to separation, though the root cause of the hockling is unknown at this time. A review of component records for the retractor control knob, retractor system inner slide tube and retractor drive cable indicate all components were conforming to their specifications. This complaint is being reported because if no intervention is performed, there is a risk of a sharp foreign body remaining inside the patient.
Patient Sequence No: 1, Text Type: N, H10
[97731800]
The user reported while attempting to disengage the helical retractor from tissue, the inner slide tube (with the retractor knob) separated from the retractor drive cable and pulled out of the device. As a result, the user intervened by accessing the remaining retractor drive cable and using hemostat clamps to disengage the helical retractor from tissue. The initial device was 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 | 3005473391-2018-00106 |
| MDR Report Key | 7173931 |
| Date Received | 2018-01-08 |
| Date of Report | 2018-01-08 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2017-11-28 |
| Device Manufacturer Date | 2017-03-20 |
| Date Added to Maude | 2018-01-08 |
| 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 | 2018-01-08 |
| Returned To Mfg | 2017-12-28 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| Lot Number | 402429 |
| Device Expiration Date | 2019-02-28 |
| 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 | 2018-01-08 |