MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-04-19 for UROPASS AS 12/14FR X 24 CM 5/BX 61224BX manufactured by Teleflex Medical Oem.
[106743770]
The device was not returned to olympus for evaluation. The cause of the reported event could not be determined at this time. In addition, limited information was provided on the medwatch report. However, 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
[106743833]
Olympus received a medwatch (mw5075914) which states? Provider used a 24 cm 12/14 fr ureteral access sheath over a guide wire per routine. The sheath was intact when it was inserted in the patient however at the bladder neck the provider encountered difficulty passing the sheath over the wire. The provider removed the sheath and noticed that part of the tip had fragmented. He immediately inspected the entire urethra including the prostatic urethra and bladder neck and noticed 4 small white pieced of plastic. The provider drained the bladder and retrieved all the pieces through the cystoscope sheath. He further inspected these areas with the cystoscope and confirmed that there were no remaining pieces of plastic. The provider reports that the sheath has been used on numerous occasions without difficulty. This was reported to be a defective sheath. The second sheath was advanced without difficulty. No injuries to the patient or staff.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00259 |
| MDR Report Key | 7445687 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-04-19 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-04-05 |
| Date Added to Maude | 2018-04-19 |
| 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 | 3 |
| Brand Name | UROPASS AS 12/14FR X 24 CM 5/BX |
| Generic Name | UROPASS ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2018-04-19 |
| Model Number | 61224BX |
| Catalog Number | 61224BX |
| Lot Number | UNKNOWN |
| ID Number | UDI |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-04-19 |