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 2018-11-01 for DRETLER URETEROSCOPY STENT SET 025506-S4 manufactured by Cook Inc.
[125910640]
Pma/510k # preamendment (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
[125910641]
It was reported, upon opening the dretler ureteroscopy stent set package, the physician noticed that an unidentified foreign matter was attaching on the tip of the catheter. The physician picked the foreign matter and pulled it back to remove it from the catheter, a 10cm string came out of the inner lumen then. The foreign matter was revealed to be a string, though from where it originated was unknown. It was replaced with another device and the procedure was completed successfully. No adverse events have been reported as a result of the alleged malfunction
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03245 |
| MDR Report Key | 8030234 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2018-07-25 |
| Date Added to Maude | 2018-11-01 |
| 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 | DRETLER URETEROSCOPY STENT SET |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-11-01 |
| Returned To Mfg | 2018-10-31 |
| Catalog Number | 025506-S4 |
| Lot Number | 9047086 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-01 |