MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..
[72801339]
There was no reported injury to the patient. Device evaluation concluded there was indication of a material or manufacturing process issue. This failure mode is being reported as the presumption that the malfunction is likely to cause or contribute to a serious injury has been previously established.
Patient Sequence No: 1, Text Type: N, H10
[72801340]
The surgeon reported the endoscope retainer band broke during insertion of the device. No additional details were provided by the customer. The device was successfully and uneventfully removed and the case was aborted. There were no adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2017-00100 |
| MDR Report Key | 6487100 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2016-11-11 |
| 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 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 | 0 |
| Brand Name | ESOPHYX2 HD |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2017-04-12 |
| Returned To Mfg | 2017-04-04 |
| Model Number | C02042-01 |
| Catalog Number | R2005 |
| Lot Number | 402371 |
| Device Expiration Date | 2018-11-11 |
| 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 | 2017-04-12 |