MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-06-22 for ESOPHYX Z C02260-02 R2006 manufactured by Endogastric Solutions, Inc..
[78229275]
The user verbally stated there is no allegation of device malfunction. The device was received and evaluated by egs and no trouble was found with the device.
Patient Sequence No: 1, Text Type: N, H10
[78229276]
Prior to device insertion, the user reported issues with video output from the endoscope. Insertion of the device was initially attempted without endoscopic visualization of the esophagus and the user reported difficulty inserting the device. An egs representative present at the procedure, reported the user used an abnormally large amount of force during insertion. On the third attempt, the device was successfully inserted into the patient but was quickly removed as no endoscopic visualization could be achieved. After fixing the endoscope video issue, the user reinserted the endoscope into the patient and noted blood present in the esophagus. In an attempt to locate the source of the bleeding, the user externally opened the patient's abdomen and neck. A perforation was found in the proximal esophagus mid-chest approximately in the same location as resistance was felt during device insertion. The perforation was successfully treated and the patient was admitted to the icu (b)(6) 2017. As of (b)(6) 2017, the patient was still in the icu in stable condition and continues to improve. The user verbally stated there is no allegation of device malfunction.
Patient Sequence No: 1, Text Type: D, B5
[96514826]
Errors listed below were found in the initial report and are being corrected in this follow-up report: incorrect brand name was provided (esophyx2 hd) and has been updated to esophyx z. Model #, catalog #, and unique identifier (udi) # were incorrect identified as c02042-01, r2005, and(b)(4). These three fields have been corrected to c02260-02, r2006, and (b)(4) respectively. Pma/510(k) was incorrectly identified as k142113. This has been corrected to k171307.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005473391-2017-00104 |
| MDR Report Key | 6662379 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-06 |
| Date Mfgr Received | 2017-06-06 |
| Device Manufacturer Date | 2016-10-18 |
| Date Added to Maude | 2017-06-22 |
| 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 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 | 3 |
| Brand Name | ESOPHYX Z |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2017-06-22 |
| Returned To Mfg | 2017-06-20 |
| Model Number | C02260-02 |
| Catalog Number | R2006 |
| Lot Number | 402375 |
| Device Expiration Date | 2018-11-23 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-06-22 |