MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for ENDOGATOR SINGLE USE AUXILIARY WATER JET CONNECTOR FOR PENTAX GI ENDOSCOPES 100242 manufactured by Medivators.
[60748487]
The facility called to report that the endogator auxiliary water jet connector for pentax gi endoscopes was leaking because oring on the plastic connector that connects to the endoscope was too big. It was reported that the physician got sprayed with irrigation fluid when he activated the irrigation system. There is potential for cross contamination exposure. Medivators quality assurance team inspected the returned connectors from this lot and the issue could not be duplicated. The water that is sprayed from the connector would have been from the sterile water bottle when used in conjunction with the irrigation pump. There was no reported injury to the physician. This complaint will continue to be monitored within medivators complaint system.
Patient Sequence No: 1, Text Type: N, H10
[60748488]
The case states that a single use auxiliary water jet connector for pentax endoscopes was leaking and sprayed the physician performing the procedure. There is potential for cross contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651395-2016-00007 |
| MDR Report Key | 6123023 |
| Date Received | 2016-11-22 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-10-25 |
| Device Manufacturer Date | 2016-09-03 |
| Date Added to Maude | 2016-11-22 |
| 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 | MEGAN DICKEY |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533327 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 3150 POLLOK DR |
| Manufacturer City | CONROE TX 77303 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77303 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOGATOR SINGLE USE AUXILIARY WATER JET CONNECTOR FOR PENTAX GI ENDOSCOPES |
| Generic Name | AUXILIARY WATER JET CONNECTOR |
| Product Code | FEQ |
| Date Received | 2016-11-22 |
| Returned To Mfg | 2016-11-08 |
| Model Number | 100242 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 3150 POLLOK DR CONROE TX 77303 US 77303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-22 |