MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-01-02 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS G46168 FUS-120045 manufactured by Cook Inc.
[178331743]
(b)(6). Pma/510k #: k172217. 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
[178331744]
It was reported that during a ureteroscopic lithotripsy, the outer sheath of a flexor ureteral access sheath cracked and caused the ureteral mucosa to bleed. The quantity of blood lost was unspecified. The ureteral bleeding resulted surgical vision loss. The surgery was suspended until a another ureteral sheath was obtained to complete the procedure. No additional consequences to the patient were reported as a result of this occurrence. Additional information has been requested regarding the patient and event. At this time, not additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00028 |
| MDR Report Key | 9538502 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-05-03 |
| Date Added to Maude | 2020-01-02 |
| 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 | UNK JENNIFER CANADA |
| 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 | FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY |
| Product Code | FED |
| Date Received | 2020-01-02 |
| Model Number | G46168 |
| Catalog Number | FUS-120045 |
| Lot Number | 9714067 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-02 |