MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-23 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[106213110]
The device was available for evaluation. After conducting an engineering evaluation, the following items were noted: the endoscope retainer band failed due to a tensile fracture, no sharps were found on the device tissue mold/chassis. 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. No definitive root cause has been identified for the perforation.
Patient Sequence No: 1, Text Type: N, H10
[106213131]
The physician noted the silicone endoscope retainer band was broken immediately after device insertion and a portion of the retainer band had separated from the device and was laying in the patient's stomach. The physician decided not to retrieve the separated portion of the retainer band and successfully completed the tif procedure. During the post-procedure egd, an esophageal perforation (the size was not reported) was noted just proximal to the most proximal deployed fastener in the gej. The physician successfully treated the perforation using a stent and sutures. The patient was admitted to the hospital (b)(6) 2018 and was discharged (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2018-00110 |
| MDR Report Key | 7452100 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2017-02-28 |
| Date Added to Maude | 2018-04-23 |
| 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 | ESOPHYX2 HD |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2018-04-23 |
| Returned To Mfg | 2018-04-06 |
| 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 ST. SUITE 100 REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-23 |