MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-11-29 for OPEN-END FLEXI-TIP URETERAL CATHETER 021305 manufactured by Cook Inc.
[129345439]
Pma/510k # pre-amendment. (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
[129345440]
The user facility report # mw5080534 was received and the report showed the customer reported, a piece of the open-end flexi-tip ureteral catheter sheared off during case. It is believed that all pieces were removed from the patient. This is now the 3rd device issue with this product. Reference mdr # 1820334-2018-03442 and mdr# 1820334-2018-03444 for the other devices reported to have the same alleged malfunction. No adverse event have been reported as a result of the alleged malfunction. Additional information has been requested regarding the patient and the event. At the time of this report, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03443 |
| MDR Report Key | 8115721 |
| Report Source | OTHER |
| Date Received | 2018-11-29 |
| Date of Report | 2018-12-26 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2018-11-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | OPEN-END FLEXI-TIP URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-11-29 |
| Catalog Number | 021305 |
| Lot Number | UNKNOWN |
| 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 | 2018-11-29 |