MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-27 for FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET G17323 AQ-022610 manufactured by Cook Inc.
[140152381]
(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
[140152382]
It has been reported that a (b)(6) year old female underwent a percutaneous nephrolithotomy. This case utilized cook's flexi-tip dual-lumen ureteral access set (gpn: g17323). A nephroscope was used concomitantly with the cook set. During this procedure it was discovered that pieces of the dual lumen sheared off in the patient's kidneys. The pieces were flushed out of the kidneys with saline and no additional procedures were required. The procedure was completed. The patient did not experience any adverse effects due to this occurrence and was discharged with no issues. The device is not available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00663 |
| MDR Report Key | 8458558 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-27 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-05-06 |
| Device Manufacturer Date | 2019-01-10 |
| Date Added to Maude | 2019-03-27 |
| 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 | FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET |
| Generic Name | EYB CATHETER, URETERAL, GASTRO-UROLOGY |
| Product Code | EYB |
| Date Received | 2019-03-27 |
| Model Number | G17323 |
| Catalog Number | AQ-022610 |
| Lot Number | 9435863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-27 |