MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-08-09 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS 076000-F140045 manufactured by Cook Inc.
[116719359]
(b)(6). Pma/510(k) #: this device is not sold in the u. S. However, there is a similar device manufactured by cook inc. That is marketed in the u. S. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[116719360]
It was reported the flexor ureteral access sheath and dilators was used for transurethral urinary stone removal. After placing the device in the urinary duct, a flexible-scope was advanced through the sheath to the urinary tract. Stone removal was performed though, foreign substances were confirmed during the procedure. The sheath was removed from the patient and the procedure was finished with the device. There have been no adverse effects to the patient reported and it is considered that the foreign substances do not remain inside the patient. The foreign substances were suspected to be scraped-off coating segments of the inner lumen of the sheath. As reported, there was no impact to the patient. Additional details of the event have been requested. At the time of this report no new information has been forthcoming.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02433 |
| MDR Report Key | 7768181 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-08-27 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2018-08-09 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXOR URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-08-13 |
| Catalog Number | 076000-F140045 |
| Lot Number | 6390859 |
| Device Expiration Date | 2018-11-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-09 |