MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-07-26 for UROPASS AS 12/14FR X 38 CM 5/BX 61238BX manufactured by Teleflex Medical Oem.
[81147119]
The device will be retained by the user facility; therefore, no evaluation can be performed. The cause the reported event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[81147120]
Olympus was informed that during a therapeutic robotic nephroureterectomy procedure, the device broke and fell into the patient as the surgeon was retrieving biopsies. The device fragment was retrieved and the sheath was withdrawn from the patient using x-ray. There was no bleeding reported. The intended procedure was completed with a similar device. There was no patient injury reported. Additionally, the user facility reported that no resistance was felt during the insertion of the device into the scope. The device was inspected prior to use with no anomalies found. The device was stored in a closed cabinet that is surrounded with fluorescent lighting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00493 |
| MDR Report Key | 6745268 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-07-26 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-06-12 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2017-07-26 |
| 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 38 CM 5/BX |
| Generic Name | UROPASS URETERAL ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2017-07-26 |
| Model Number | 61238BX |
| Catalog Number | 61238BX |
| Lot Number | 09G1600102 |
| ID Number | UDI |
| 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 | 2017-07-26 |