MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for UROPASS AS 13/15FR X 46 CM 5/BX 61346BX manufactured by Teleflex Medical Oem.
[107089109]
The device was discarded by the user facility and will not be returned to olympus for evaluation. The cause of the reported event could not be determined. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly. Device was discarded
Patient Sequence No: 1, Text Type: N, H10
[107089110]
Uropass broken in patient. Customer had an issue when inserting the sheath over a guidewire into the ureter. When the middle section of the sheath was removed it was noted that the white tapered tip was split. The user was a registrar but they do use the product regularly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005975494-2018-00006 |
| MDR Report Key | 7458863 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-12-06 |
| Date Added to Maude | 2018-04-25 |
| 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 TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UROPASS AS 13/15FR X 46 CM 5/BX |
| Generic Name | UROPASS |
| Product Code | KNY |
| Date Received | 2018-04-25 |
| Model Number | 61346BX |
| Lot Number | 09M1500100 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-25 |