MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-13 for UROPASS AS 12/14FR X 46 CM 5/BX 61246BX manufactured by Teleflex Medical Oem.
[100134518]
The device was not returned to olympus for evaluation. The exact cause of the reported event cannot be determined; however, based on similar reports the root cause for the reported event is substantial light exposure of the devices in the health care facility, which resulted in degradation and embrittlement of the dilator polymer.
Patient Sequence No: 1, Text Type: N, H10
[100134519]
Olympus was informed that during an unspecified procedure, the ureteral access sheath tip broke off and fell inside the patient. The device fragment was retrieved. The intended procedure was completed with a similar device. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00103 |
| MDR Report Key | 7267447 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-13 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2018-02-13 |
| 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 46 CM 5/BX |
| Generic Name | UROPASS AS 12/14FR X 46 CM 5/BX |
| Product Code | KNY |
| Date Received | 2018-02-13 |
| Returned To Mfg | 2018-02-21 |
| Model Number | 61246BX |
| Catalog Number | 61246BX |
| Lot Number | 09M1400189 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-02-13 |