MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-13 for ESOPHYX Z+ C02419-01 R2007 manufactured by Endogastric Solutions, Inc..
[105386892]
The device was available for evaluation; an engineering device evaluation was performed, and the following items were noted: the helical retractor drive cable was bent 35? -45? And the retractor helix was bent 30? -40?. No manufacturing defect was found and no assignable cause was identified. No definitive root cause was identified for the bend in the retractor drive cable immediately after device insertion. As the customer was able to complete the procedure with the initial device, the bend in the retractor helix is likely to have occurred towards the end of the procedure as tissue cannot be appropriately captured in the bent condition. 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.
Patient Sequence No: 1, Text Type: N, H10
[105386893]
Prior to device insertion, the helical retractor control was verified in it's safe home position with the retractor lock in the locked position. The physician began inserting both the device and endoscope. Sometime during insertion (around the patient's pharynx area) the physician handed the endoscope to the endoscope operator. The physician then completed insertion of the device. Once in the stomach, the endoscope was retroflexed and the distal portion of the helical retractor was seen outside of the device tissue mold, the helical retractor lock was in the unlocked position and the retractor control was partially advanced into the handle of the device. The retractor drive cable was seen bent approximately 35? -45? Just proximal to the helical retractor hub. After considering all options (e. G. Abort procedure, obtain a new device, etc. ) the physician decided to continue the procedure with the initial device. The physician successfully completed the procedure and uneventfully removed the device with the helical retractor safely stowed. A post-procedure egd was completed and a 4 cm esophageal tear present approximately 26-30 cm from the patient's incisors. The physician is not alleging any product malfunction causing or contributing to the reported patient injury. Due to medical necessity, the patient was kept in the hospital following the procedure. The patient's discharge was delayed due to other health issues unrelated to the tif procedure. The patient was discharged after 8 days, though the physician stated the patient's stay would've been 3-5 days without the additional health issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005473391-2018-00108 |
| MDR Report Key | 7428525 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-03-12 |
| Date Mfgr Received | 2018-03-12 |
| Device Manufacturer Date | 2017-11-16 |
| Date Added to Maude | 2018-04-13 |
| 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 | ESOPHYX Z+ |
| Generic Name | ODE |
| Product Code | ODE |
| Date Received | 2018-04-13 |
| Returned To Mfg | 2018-03-28 |
| Model Number | C02419-01 |
| Catalog Number | R2007 |
| Lot Number | 402556 |
| Device Expiration Date | 2019-11-16 |
| 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 | 2018-04-13 |