MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-09 for COOK OPEN-END URETERAL CATHETER G14818 manufactured by Cook Medical Inc.
[51497212]
Patient Sequence No: 1, Text Type: N, H10
[51497213]
While performing a cystoscopy the physician was using an open-ended ureteral catheter when the catheter end broke off during insertion into the scope and prior to insertion into the patient. All pieces were recovered, the complete catheter was retrieved and fluoro was used to ensure no pieces were in patient. The patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5856130 |
| MDR Report Key | 5856130 |
| Date Received | 2016-08-09 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-02-09 |
| Report Date | 2016-08-05 |
| Date Reported to FDA | 2016-08-05 |
| Date Reported to Mfgr | 2016-08-05 |
| Date Added to Maude | 2016-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | COOK OPEN-END URETERAL CATHETER |
| Generic Name | CATHETER, URETERAL, GASTRO-UROLOGY |
| Product Code | EYB |
| Date Received | 2016-08-09 |
| Catalog Number | G14818 |
| Lot Number | 6150768 |
| ID Number | 020013 |
| Device Expiration Date | 2018-08-25 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-09 |