MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for UROPASS AS 12/14FR X 38 CM 5/BX 61238BX manufactured by Teleflex Medical Oem.
[121590408]
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined. However, the 61238bx instruction manual warns users? Avoid contact with sharp objects as the device can be easily nicked, thereby increasing the potential for breakage. Upon completion of the procedure, gently withdraw the sheath.?
Patient Sequence No: 1, Text Type: N, H10
[121590409]
Olympus was informed that at the conclusion of an unspecified procedure, while withdrawing the access sheath 2-3 inches of the sheath? S tip broke off in the patient. The device fragment was successfully retrieved. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00566 |
| MDR Report Key | 7900292 |
| Date Received | 2018-09-21 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-07-13 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2018-09-21 |
| 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 12/14FR X 38 CM 5/BX |
| Generic Name | UROPASS URETERAL ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2018-09-21 |
| Model Number | 61238BX |
| Catalog Number | 61238BX |
| Lot Number | 09G1400007 |
| 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 | 2018-09-21 |