MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS FUS-120045 manufactured by Cook Inc.
[116273312]
Concomitant medical products: semi-rigid and flexible scopes, motion hybrid wire guide. (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
[116273313]
It was reported the physician was using the flexor ureteral access sheath with the scope, and the inner? Liner? From the outside sheath peeled away. Case was completed as normal. Additional information was provided during follow up. The sheath was taken out of the patient and the stent was placed. No unintended section of the device remained inside the patient's body. The patient did not require any additional procedures due to this occurrence. There were no adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02437 |
| MDR Report Key | 7757486 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2017-06-22 |
| Date Added to Maude | 2018-08-07 |
| 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 | 2018-08-07 |
| Returned To Mfg | 2018-08-16 |
| Catalog Number | FUS-120045 |
| Lot Number | 8010615 |
| 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 | 2018-08-07 |