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 2020-01-03 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS 076000-F120035 manufactured by Cook Inc.
[178332773]
(b)(6). This device is not sold in the united states. There are similar devices sold in the united states, for example catalog number fus-095020. Information for fus-095020: common device name: fed endoscopic access overtube/gastroenterology-urology, , and pma/510(k) #: 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
[178332794]
It was reported, a foreign matter which appeared to be white plastic debris was observed inside the sealed packaging of a flexor ureteral access sheath and dilators. The issue was discovered during the incoming quality inspection at the hospital. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00050 |
| MDR Report Key | 9546542 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-01-03 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-10-28 |
| Date Added to Maude | 2020-01-03 |
| 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 | MRS. 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 |
| Product Code | FED |
| Date Received | 2020-01-03 |
| Returned To Mfg | 2020-01-15 |
| Catalog Number | 076000-F120035 |
| Lot Number | 10110276 |
| 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 | 2020-01-03 |