MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-02-27 for ESOPHYX Z C02260-02 R2006 manufactured by Endogastric Solutions, Inc..
[101119381]
On (b)(6) 2018, egs was notified the patient was diagnosed with a pneumothorax. The tif physician was unsure if the pneumothorax was caused by the medium thickness laceration or the hiatal hernia repair. It is the egs chief medical officer's medical opinion that a medium thickness esophageal laceration will not cause or contribute to air leaking into the chest cavity. The device was unavailable for evaluation; however, the customer verbally stated he is not alleging any product malfunction causing or contributing to the adverse event.
Patient Sequence No: 1, Text Type: N, H10
[101119382]
A hiatal hernia repair was performed concomitantly to a tif procedure. While inserting the esophyx z device with a pediatric endoscope, the customer noted the endoscope retroflexed in the patient's esophagus. The device and endoscope were removed from the patient. The customer attempted a second insertion with the endoscope extended past the end of the tissue mold approximately 1cm, when resistance was encountered. The device and endoscope were again removed from the patient. An egd was then performed and nothing was found, though an esophageal perforation was suspected approximately between 11-15cm from the patient's incisors. The procedure was aborted and the patient was transferred to another medical facility. A ct scan with contrast was performed (b)(6) 2018 and the results were interpreted as a full thickness esophageal perforation. A thoracic surgeon performed an exploratory surgery (b)(6) 2018 to inspect the esophagus. No perforation was found but a 4cm medium thickness esophageal laceration was noted. The thoracic surgeon left a drain and ng tube in the patient. The patient remained in the hospital as of (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2018-00107 |
| MDR Report Key | 7301764 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-02-27 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-01-29 |
| Date Mfgr Received | 2018-01-29 |
| Device Manufacturer Date | 2017-10-11 |
| Date Added to Maude | 2018-02-27 |
| 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 | ENDOGASTRIC 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 | 3 |
| Brand Name | ESOPHYX Z |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2018-02-27 |
| Model Number | C02260-02 |
| Catalog Number | R2006 |
| Lot Number | 402510 |
| Device Expiration Date | 2019-10-11 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS, INC. |
| Manufacturer Address | 18109 NE 76TH STREET SUITE 100 REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-02-27 |