MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-12 for ESOPHYX Z C02260-02 R2006 manufactured by Endogastric Solutions, Inc..
[72610913]
The procedure was completed successfully and the patient was admitted and discharged (b)(6) 2017 after an esophagram was performed and no issues were identified. The device was available from the hospital for evaluation; an engineering device evaluation was performed on the returned product. Although the customer alleged a device malfunction occurred, no device failure was confirmed during the engineering device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[72610914]
The user reported significant resistance while attempting to remove the device from the patient at the end of the procedure. The endoscope was also unable to be removed from the device. More lubricant was added to the device/endoscope interface but the endoscope remained unable to be removed. During this time, it was reported an orange color was seen on the endoscope monitor. A secondary endoscope was inserted and observed the device tissue mold stuck 25-35 degrees from fully open. The first endoscope was able to be pulled back out of the tissue mold after manipulating the endoscope controls. The device was then successfully removed from the patient. During the post-procedure egd, a 2-3 cm long laceration was seen on the esophagus located laterally above the gej (approximately 35-37 cm from the mouth of the patient). The user treated the laceration with 3 endoclips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2017-00101 |
| MDR Report Key | 6487127 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2016-11-04 |
| Date Added to Maude | 2017-04-12 |
| 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 | 2017-04-12 |
| Returned To Mfg | 2017-03-28 |
| Model Number | C02260-02 |
| Catalog Number | R2006 |
| Lot Number | 402370 |
| Device Expiration Date | 2018-11-04 |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-04-12 |