MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-10 for UROPASS AS 12/14FR X 54 CM 5/BX 61254BX manufactured by Teleflex Medical Oem.
[80026787]
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[80026788]
Olympus was informed that during unspecified procedure, the sheath broke off and fell inside the patient. It is unknown if device fragments were retrieved. It is unknown if the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00445 |
| MDR Report Key | 6697940 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-10 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-08-22 |
| Date Added to Maude | 2017-07-10 |
| 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 54 CM 5/BX |
| Generic Name | UROPASS URETERAL ACCESS SHEALTH |
| Product Code | KYN |
| Date Received | 2017-07-10 |
| Returned To Mfg | 2017-07-20 |
| Model Number | 61254BX |
| Catalog Number | 61254BX |
| Lot Number | 09L1200106 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL OEM |
| Manufacturer Address | 3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MA 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-10 |