MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-03 for ESOPHYX Z R2007 manufactured by Endogastric Solutions, Inc..
[177933913]
The physician is not alleging a device malfunction caused or contributed to the patient injury. The physician is alleging the tif procedure caused or contributed to the patient's injury. The physician did confirm that the placement of the endoclips were medically necessary and the patient was hospitalized. The returned device was evaluated by endogastric solutions. The retractor system functioned as intended. A review of manufacturing records for the product lot indicate no manufacturing non-conformances were written for this product lot. No root cause has been identified for the noted failure. This is being reported due to patient adverse event and intervention that was medically necessary to preclude permanent damage to a bodily function or structure.
Patient Sequence No: 1, Text Type: N, H10
[177933914]
During a tif procedure, the customer engaged the helix into the tissue following normal tif protocol but the helix pulled out of the tissue. The customer was engaging the helix into a large blood blot on the lip of the gej. The blood clot was washed off the gej and a hole was seen in the lip of the gej. The procedure was stopped and 8 endoclips were placed on the gej to treat the hole and associated bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2020-00129 |
| MDR Report Key | 9662512 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-09-13 |
| Date Added to Maude | 2020-02-03 |
| 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. VISHNU VENKATESAN |
| Manufacturer Street | 18109 NE 76TH ST SUITE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4253079248 |
| 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 | ESOPHYX Z |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2020-02-03 |
| Returned To Mfg | 2020-01-28 |
| Model Number | R2007 |
| Catalog Number | R2007 |
| Lot Number | 402842 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-02-03 |