MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2020-02-25 for NCIRCLE TIPLESS STONE EXTRACTOR NTSE-022115-UDH manufactured by Cook Inc.
[180771127]
(b)(6). Occupation: other non-healthcare professional: coordinator. Pma/510k # exempt. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[180771128]
It was reported that prior to an unknown procedure, a ncircle tipless stone extractor was removed from the packaging and found to not open and close as intended. The product dud not make patient contact. It is currently unknown how the procedure was completed. No adverse effects to the patient have been reported due to this incident. Additional patient and event information has been requested. At this time, all known information is included. A follow up report will be submitted if additional details requested are received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00448 |
| MDR Report Key | 9749788 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2020-02-25 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2019-09-13 |
| Date Added to Maude | 2020-02-25 |
| 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 | 2020-02-25 |
| Catalog Number | NTSE-022115-UDH |
| Lot Number | 10010533 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-02-25 |