MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for UROPASS AS 11/13FR X 46 CM 5/BX 61146BX manufactured by Teleflex Medical Oem.
[119538670]
The device has not been returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. Olympus is awaiting additional information from the original equipment manufacturer (oem). This report will be updated if additional information is received regarding the device malfunction or impact to the patient. To prevent injury to the patient, the device instructions for use document 08021 rev. Be warns? Do not insert this device if it has been kinked or damaged prior to use? Replace with undamaged product?. Also,? Avoid contact with sharp objects as the device can be easily nicked?. The document also warns not to advance the device if resistance is felt or the dilator is missing. The placement of the dilator/sheath assembly must also be confirmed via fluoroscopy. The instruction manual also specifies compatible guide wire dimensions.
Patient Sequence No: 1, Text Type: N, H10
[119538671]
Olympus was informed that during a therapeutic ureteroscopy and laser procedure, a longitudinal piece of the dilator tip of the device broke off into the patient? S bladder. The fragment was retrieved using grasping forceps. There was no reported patient injury. The procedure was completed with another similar device. It was reported that the clinician had noticed that the device tip was at an unusual angle prior to insertion of the device into the ureteral orifice. The device had then been inserted using a separate olympus ptfe guidewire, which was later also observed sticking out of the side of the dilator tip. It was reported that the device had been inspected prior to use with no anomalies found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00500 |
| MDR Report Key | 7839863 |
| Date Received | 2018-08-31 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-12-14 |
| Date Added to Maude | 2018-08-31 |
| 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 11/13FR X 46 CM 5/BX |
| Generic Name | UROPASS URETERAL ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2018-08-31 |
| Model Number | 61146BX |
| Lot Number | 09F1700104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |