MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for ENDOGATOR 100241 manufactured by Medivators Inc..
[176962148]
During numerous endoscopy's, the "endogator single use auxiliary water jet connector" that was connected to olympus gastroenterology endoscopes either broke off completely or began to leak while they were using the water jet. I talked to ambulatory care center (acc) nurses, and they said, between their unit and the operating room, over the last 4 to 6 weeks or so, they have had about a dozen of the endogator water jet connectors either fail or break. When the connectors would fail without breaking off, they would leak between the small seal and a connecting piece of plastic, causing limited water to be used in the cleaning process during the endoscopy. If the connector completely broke off, the procedure would need to be stopped until the broken piece could be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9646658 |
| MDR Report Key | 9646658 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-10 |
| Report Date | 2020-01-23 |
| Date Reported to FDA | 2020-01-23 |
| Date Reported to Mfgr | 2020-01-30 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOGATOR |
| Generic Name | ENDOSCOPIC IRRIGATION/SUCTION SYSTEM |
| Product Code | OCX |
| Date Received | 2020-01-30 |
| Model Number | 100241 |
| Catalog Number | 100241 |
| Lot Number | 440895 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | 14605 28TH AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |