MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for UROPASS AS 10/12FR X 24 CM 5/BX 61024BX manufactured by Teleflex Medical Oem.
[122461223]
The device was retained by the user facility. Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result. The cause of the reported event could not be determined at this time. If additional information becomes available or if the device is returned to olympus for evaluation, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[122461224]
Olympus was informed that during an unspecified procedure, the sheath broke in the patient. It is unknown if the device fragment was retrieved or if the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00588 |
| MDR Report Key | 7920935 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2018-09-10 |
| Date Added to Maude | 2018-09-28 |
| 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 | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UROPASS AS 10/12FR X 24 CM 5/BX |
| Generic Name | UROPASS ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2018-09-28 |
| Model Number | 61024BX |
| Catalog Number | 61024BX |
| Lot Number | 09B1800250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-09-28 |