MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for UROPASS AS 11/13FR X 46 CM 5/BX 61146BX manufactured by Teleflex Medical Oem.
[90310540]
There was no record to indicate whether the device was returned to olympus for evaluation. The cause of the reported event could not be determined at this time. However, if additional information becomes available or if the device is returned for evaluation at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[90310541]
Olympus received a voluntary report (mw5071935) which states the tip at the distal end of the sheath split while performing a cysto-retrograde pyelogra. There was limited information regarding the reported event and the user facility/contact information was unidentified on the voluntary report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00674 |
| MDR Report Key | 6941194 |
| Date Received | 2017-10-11 |
| Date of Report | 2018-12-07 |
| Date of Event | 2017-08-18 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2017-10-11 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UROPASS AS 11/13FR X 46 CM 5/BX |
| Generic Name | UROPASS AS 11/13FR X 46 CM 5/BX |
| Product Code | KNY |
| Date Received | 2017-10-11 |
| Model Number | 61146BX |
| Catalog Number | 61146BX |
| Lot Number | 09F1600052 |
| ID Number | UDI |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL OEM |
| Manufacturer Address | 3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |