MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-01 for ENDOGATOR AUXILIARY WATER JET CONNECTOR 100310 manufactured by Medivators.
[84610964]
A facility reported that blood/fluid backflow was observed in the irrigation pump tubing during a procedure while using medivators endogator auxiliary water jet connector. The initial report included photographic evidence of the tubing and connector involved in this incident. It is unknown if the facility replaced/switched out both the tubeset and auxilliary connector after the procedure as instructed in medivators endogator endoscopy irrigation tubing ifu. There is potential cross contamination between patient procedures. Medivators was unable to confirm if the facility was using the endogator auxiliary water jet connector with medivators endogator tubing which it is specifically intended for use with, thus potential off label use of the device. To date, there have been no reported illnesses or injuries as a result of this incident. This complaint will continue to be monitored within medivators complaint system.
Patient Sequence No: 1, Text Type: N, H10
[84610965]
A facility reported blood/fluid backflow in the tubing to the pump during a procedure using medivators auxiliary water jet connector. There is potential for patient cross contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651395-2017-00002 |
| MDR Report Key | 6839309 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-01 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-08-02 |
| Device Manufacturer Date | 2017-04-25 |
| Date Added to Maude | 2017-09-01 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 3150 POLLOK DRIVE |
| Manufacturer City | CONROE TX 77303 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77303 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOGATOR AUXILIARY WATER JET CONNECTOR |
| Generic Name | AUXILIARY WATER JET CONNECTOR |
| Product Code | FEQ |
| Date Received | 2017-09-01 |
| Returned To Mfg | 2017-08-22 |
| Model Number | 100310 |
| Lot Number | 855261 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 3150 POLLOK DRIVE CONROE TX 77303 US 77303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-01 |