MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for FLEXOR G34879 FUS-107035 manufactured by Cook Incorporated.
[117017246]
During ureteroscopy, the cook ureteral sheath frayed, leaving a shred of plastic in the urinary tract during ureteroscopy/ stone removal. Being that the shred was so small, several graspers did not work. The foreign body was finally removed prior to completion of procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7780282 |
| MDR Report Key | 7780282 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-05-29 |
| Report Date | 2018-07-19 |
| Date Reported to FDA | 2018-07-19 |
| Date Reported to Mfgr | 2018-08-14 |
| Date Added to Maude | 2018-08-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXOR |
| Generic Name | DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-08-14 |
| Model Number | G34879 |
| Catalog Number | FUS-107035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-14 |