MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-22 for ESOPHYX Z+ C02419-01 R2007 manufactured by Endogastric Solutions, Inc..
[106141118]
The device was available for evaluation. After conducting an engineering evaluation, the following items were noted: deformation was present on the chamfers of the left pusher skive (posterior channel). No issues found with the operation of the tissue mold. No sharp edges were found on the device. No manufacturing defects were found. A review of the product dhr indicates all components used in this product lot are within specification and the device passed normal manufacturing final acceptance testing. The posterior channel failure did not cause a patient injury. Based on the location of the laceration, the inside bend of the chassis/tissue mold would be in contact with the tissue and not the overlapping device links. It is unlikely tissue caught between the device tissue mold/chassis links caused this injury. No definitive root cause has been identified for the laceration.
Patient Sequence No: 1, Text Type: N, H10
[106141119]
After device insertion, the customer reported the posterior channel of the device became jammed when attempting to load fasteners. The customer decided to remove the device, and felt they were unable to fully open the tissue mold. While attempting to completely open the tissue mold, the device was re-positioned via rotation, retraction and insertion within the stomach with no avail. The customer re-oriented the device for device removal and the tissue mold remained unable to fully open. The endoscope was then advanced to the tip of the tissue mold and the tissue mold reportedly straightened out and the device was removed. During the post device removal egd, a 4cm esophageal laceration located longitudinal to the length of the esophagus on the anterior side of the esophagus just proximal to the gej was noted. The physician suspects tissue was "caught" between the tissue mold chassis links upon opening the tissue mold. The customer placed two endoclips to treat the laceration, the patient was admitted to the hospital and was subsequently discharged soon after (the exact date was not reported).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2018-00109 |
| MDR Report Key | 7449774 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-22 |
| Date of Report | 2018-04-22 |
| Date of Event | 2018-03-24 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2018-02-05 |
| Date Added to Maude | 2018-04-22 |
| 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 ST 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 ST 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 | 3 |
| Brand Name | ESOPHYX Z+ |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2018-04-22 |
| Returned To Mfg | 2018-04-03 |
| Model Number | C02419-01 |
| Catalog Number | R2007 |
| Lot Number | 402581 |
| 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 ST. SUITE 100 REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-22 |