MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-09 for NCIRCLE TIPLESS STONE EXTRACTOR NTSE-022115-UDH manufactured by Cook Inc.
[182921926]
Pma/510k # exempt. 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
[182921927]
It was reported that during an unknown point of an unknown procedure, that the protective sheath of a ncircle tipless stone extractor separated from the handle. It is unknown how the procedure was completed. No adverse effects to the patient have been reported at this time. Additional information has been requested, but it was reported that information for this case would not be available for a "few weeks". A follow up report will be submitted if additional details become available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00570 |
| MDR Report Key | 9805778 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-09 |
| 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 | MRS. JENNIFER CANADA |
| 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 | NCIRCLE TIPLESS STONE EXTRACTOR |
| Generic Name | FFL DISLODGER, STONE, BASKET, URETERAL, METAL |
| Product Code | FFL |
| Date Received | 2020-03-09 |
| Catalog Number | NTSE-022115-UDH |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-09 |